Efficacy and safety of perioperative analgesia in PENG block for children undergoing hip surgery with developmental dysplasia: study protocol for a randomized, double-blinded, non-inferiority trial (2025)

  • Study protocol
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  • Mingzhe Xu1,2,
  • Yi He1,2,
  • Zhi Li3 &
  • Bin Du1,2

Trials volume26, Articlenumber:19 (2025) Cite this article

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Abstract

Background

Surgical intervention is critical in the treatment of hip developmental dysplasia in children. Perioperative analgesia, usually based on high opioid dosages, is frequently used in these patients. In some circumstances, regional anesthetic procedures such as caudal block and lumbar plexus block have also been used. Previous research has shown that pericapsular nerve group (PENG) block provides excellent anesthetic efficacy during open hip surgery in adults. PENG block is thought to provide a similar analgesia effect comparable to caudal block.

Methods

This study is a single-center, prospective, randomized, double-blinded, non-inferiority experiment that enrolled children aged 6months to 7years who were scheduled for developmental dysplasia hip surgery. Following general anesthesia and regional blocks (0.25% ropivacaine at a dose of 2.5mg·kg−1 with epinephrine at a concentration of 1:200,000), 48 individuals will be randomly assigned to either the PENG or caudal groups. The primary outcome measure is the highest FLACC (face, legs, activity, crying, consolability) score achieved within 24h of surgery. Secondary outcomes include intraoperative opioid consumption, analgesic dosage within 24h of surgery, time to start rescue analgesia, number of PCA pump activations, time to remove SLIPA (streamlined liner of the pharynx airway), duration of regional block procedures, incidence of adverse events, plasma ropivacaine concentrations, and hospital stays and costs. All data will be collected by blinded investigators. The trial’s final results will be published in a peer-reviewed scientific journal.

Discussion

We expect this trial to provide some evidences that PENG block is safe and effective for perioperative analgesia in pediatric patients undergoing open hip surgery.

Trial registration

Chinese Clinical Trial Registry ChiCTR2100053128. Registered on November 12, 2021.

Peer Review reports

Background

Developmental dysplasia of the hip (DDH) refers to a group of developmental abnormalities that affect the hip joint and cause impairment in children [1]. The reported frequency of clinical hip instability in newborns ranges from 1.6 to 28.5‰ [1]. The treatment strategy for DDH seeks to achieve concentric hip reduction of the hip while also assuring functional and anatomical outcomes. To overcome anatomic impediments impeding concentric reduction, an open surgical procedure is advised, particularly for children aged 12 to 18months or younger children who have not responded to closed reduction [2]. Surgical intervention entails open hip and pelvic osteotomies, which can cause severe or significant immediate postoperative pain in pediatric patients. Postoperative pain may be linked with restlessness, making postoperative immobilization with a hip spica cast difficult and hinder recovery. Furthermore, acute pain has the potential to develop into chronic pain, reducing future quality of life.

Unrelieved pain during childhood has both immediate and long-term effects on sensory perception, stress response, and emotional well-being as seen by reduced sensitivity towards acute versus chronic and/or severe stimuli [3]. Adequate postoperative pain treatment is essential for achieving excellent surgical outcomes by decreasing complications and fostering faster recovery rates. Because of its effective analgesic qualities and stable hemodynamic profile, opioid-based analgesia has been used for perioperative pain control [4]. Opioids, on the other hand, are associated with complex problems in children such as respiratory depression, acute urinary retention, atelectasis, and so on [5].

Multimodal anesthesia, which includes regional anesthetic and NSAIDs, has been advocated and developed to minimize postoperative pain [6]. Caudal block is a frequent perioperative pain control technique in children undergoing hip surgery, accounting for 34–40% of pediatric regional anesthesia [7, 8]. On the other hand, the age-dependent efficacy of analgesia poses a substantial barrier to caudal block, particularly in hip surgery. According to several studies, caudal block is typically provided to children aged 12months to 3years [7, 8], making it unsuitable for older children. Furthermore, urinary retention poses significant problems in these patients. Ultrasound-guided procedures are increasingly being used in clinical practice, particularly in regional anesthesia programs. Lumbar plexus block (LPB) with ultrasound guidance has been presented as a preferable alternative to caudal block [9], delivering effective unilateral analgesia while decreasing urinary retention. Nonetheless, potential adverse effects and serious complications, such as lumbar artery puncture with or without intra-arterial injection, neuraxial spread, bilateral diffusion, and proximity [10], limit the use of LPB.

Ultrasound-guided pericapsular nerve group (PENG) block, first described by Giron in 2018, targets the articular branches of the femoral, obturator, and accessory obturator nerves, which give sensory innervation to the anterior hip capsule [11]. PENG block has been reported to be beneficial for hip-related analgesia, which including hip fractures, hip surgery, and so on [12]. Fortunately, no major complications or needle-related organ injury have been documented [12]. PENG block has been studied in randomized controlled trials for elective hip surgery in adults [13, 14] and case reports for its application in children [15].

PENG block versus caudal block for analgesia during hip surgery in children with developmental dysplasia of the hip (DDH) is compared in this randomized non-inferiority research. The primary goal is to assess the efficacy, safety, and feasibility of PENG block application in this population while ropivacaine plasma concentrations will be assessed as a safety indicator to compare the two blocks’ local anesthetic absorption.

Methods/design

Study design and setting

A prospective, double-blind, randomized, single-center non-inferiority parallel-group 2-arm study with a 1:1 allocation ratio was conducted at West China Hospital in China. Figure1 depicts the study flow chart, and the protocol corresponds to the SPIRIT 2013 statement [16]. Table 1 shows the participant timeline for patient enrollment and assessment.

The flow chart of this study. DDH, developmental dysplasia of the hip; PENG, pericapsular nerve group; FLACC, face, leg, activity, cry, consolability; PCA, patient-controlled analgesia; SLIPA, pharyngeal airway

Full size image
Full size table

Ethics and dissemination

The Ethics Committee on Biomedical Research, West China Hospital of Sichuan University approved the study on January 13, 2022 (2021–1607). The study was registered with the Chinese Clinical Trial Registry (ChiCTR2100053128) on 12 November, 2021. The study findings will be published in peer-reviewed journals.

Participant and informed consent

An impartial investigator will undertake recruitment on the ward 1day before surgery, based on pre-defined inclusion and exclusion criteria. Table 2 summarizes the study’s eligibility requirements. The investigator will describe the study’s objective, procedures, benefits, and potential risks to participants’ guardians before obtaining informed permission. Guardians have access to all relevant information throughout the trial period and may revoke their consent at any moment. We have not implemented any additional measures to promote participant retention.

Full size table

Randomization and blinding

A random number produced by Excel will be used to assign patients to either the caudal block or PENG block groups, with a 1:1 allocation ratio maintained. The group assignment for each member will be sealed in an envelope. The randomization process will be conducted by an independent statistician who will not involve in data analysis. Individual anesthesiologists will provide regional anesthesia (he will not take part in management of perioperative period and follow-up visit), and a specialized anesthesiologist in charge of monitor intraoperative care, while postoperative follow-up researchers will be barred from accessing the operating room. Allocation blinding will be maintained for the anesthesiologists (in charge of intraoperative care and follow-up), participants, surgeons, and statisticians will all be allocated blind until the final analyses are completed. Unless a research-related serious adverse event occurs, the principal investigator will report any unblinding immediately if necessary; otherwise, we will not unblind.

Interventions

All participants will be given general anesthesia using our standard anesthetic program, while an experienced anesthesiologist will administer regional anesthesia and a designated pediatric surgeon will perform surgical procedures using the same technique. All medications were administered in accordance with the protocol; no concomitant medications were allowed in our study.

All patients are subjected to standard electrocardiography, pulse oximetry, and noninvasive blood pressure monitoring as soon as they reach the operation room. To ease insertion of a streamlined liner of the pharyngeal airway (SLIPA), both groups receive conventional general anesthesia consisting of intravenous midazolam 0.05mg·kg−1, sufentanil 0.3–0.5µg·kg−1, propofol 2–3mg·kg−1, and cis-atracurium0.1–0.2mgkg−1. Anesthesiologist skilled in PENG block and caudal blocks will conduct the relevant block according to the group at 1ml·kg−1 each utilizing a total of 0.25% ropivacaine with 1:200,000 epinephrine. They will not be involved in management of perioperative period and follow-up visit. Anesthesia is maintained with sevoflurane at a minimum alveolar concentration (MAC) level of 1.5 to keep that the bispectral index monitor (BIS) remains within the 40–60 range. Mechanical ventilation (6–8ml·kg−1) with a 50% air/oxygen mixture is used; goal end-tidal carbon dioxide (ETCO2) pressure is maintained between 35 and 45mmHg for both groups. An independent anesthesiologist who does not participate in regional anesthesia procedures manages hemodynamic parameters during surgery providing sufentanil and muscle relaxant drugs as needed by while keeping them within the preoperative baseline levels. A patient-controlled analgesia (PCA) pump will be activated 30min prior to completion of surgery. The SLIPA removal will be thoroughly assessed by anesthesiologists immediately after surgery in the operating room.

Ultrasound-guided pericapsular nerve group block

The patient is positioned supine with 90° abduction of the hip and knee, followed by adequate skin disinfection. The PENG block is performed using the ultrasound-guided technique described by Giron [11]. A 6–14MHz linear transducer is placed in the transverse plane across the anterior inferior iliac spine (AIIS) and then rotated 30–45° to align with the pubic ramus [12]. AIIS, iliopubic eminence (IPE), iliopsoas tendon (IPT) are easily visible anatomical landmarks under ultrasound assistance. After positioning the ultrasound probe accurately, local anesthetic will be injected into the plane between IPE and IPT after negative aspiration utilizing an in-plane technique and a 22G*50mm atraumatic needle for peripheral nerve blocks.

Caudal block

The sacral hiatus can be detected using traditional anatomical landmarks in the left decubitus posture with flexed hips and knees. Firstly, by palpating the posterior superior iliac spines yields a line (known as Tuffier’s line) that forms the base of an equilateral triangle, with its tip identifying the position of the sacral hiatus [17]. A caudal needle is inserted at an approximate angle above the sacral hiatus under aseptic circumstances. Subsequently, changing to a flatter angle when the resistance is gone facilitates entrance into the epidural space. Above important, aspirating before injecting local anesthetic should be done with attention to avoid unintentional intravascular or spinal injection.

Ropivacaine concentration

The venous blood samples will be taken at 10, 30, and 60min after regional anesthesia. Following that, the plasma samples will be separated, frozen, and stored at − 80°C until they can be analyzed within 1h of collection. The amounts of ropivacaine will be measured by liquid chromatography tandem mass spectrometry [18].

Postoperative period

All patients received standardized procedures from our hospital for post-trial care to ensure the safety of all patients. Following the removal of SLIPA, patients will be transported to the post-anesthesia care unit (PACU) for continued anesthesia recovery and achieving an Aldrete score ≥ 9. In all patients, a PCA pump containing sufentanil 2μg·kg−1 and ondansetron 0.1mg·kg−1 diluted in 100ml of normal saline will be used for 72h after surgery. The background infusion rate is set at 2ml·h−1, with extra 0.5ml boluses accessible upon patient request; however, each subsequent button press will be locked within a 15-min time period. If the PCA pump fails to provide adequate coverage (face, leg, activity, cry, consolability [FLACC] scores ≥ 4), a rescue analgesic consisting of intravenous sufentanil at a dose of 0.1μg·kg−1 can be administered in the PACU or oral ibuprofen at a dose range between 5 and 10mg·kg−1 can be given in the ward as an alternative measure, and all rescue analgesic will be recorded and analyzed. Using an electronic pain management database system, all data related to PCA pump usage, including the number and timing of button presses as well as drug consumption, will be accurately recorded in real-time.

Outcomes

The primary objective of this study is to compare the analgesic efficacy of ultrasound-guided PENG block to caudal block in pediatric patients with DDH who are scheduled for hip surgery.

Primary outcome

The primary outcome of this study is the maximum FLACC score among the 5 time points (1h, 3h, 6h, 12h, and 24h after extubation postoperatively).

Secondary outcomes

This study also assesses the following secondary outcomes:

  1. (A)

    The total consumption of the opioids per weight intraoperative

  2. (B)

    Consumption of analgesic medication (morphine equivalent) within 24h postoperatively

  3. (C)

    The timing of the first application of rescue analgesia

  4. (D)

    Use of PCA pump (effective/ineffective pressing number)

  5. (E)

    Time of SLIPA removal post-surgery

  6. (F)

    The plasma concentration of ropivacaine

  7. (G)

    Operation time for two blocks

  8. (H)

    Possible related adverse events (urinary retention and vomiting, and block related)

  9. (I)

    Hospital expenses and lengths of stay

Sample size calculation

The max FLACC scores at rest within 24h postoperatively (1h, 3h, 6h, 12h, 24h after extubation) are used as the primary outcome for sample size calculation in this study, which is planned as a non-inferiority trial, utilizing PASS software V.15.0.5. Based on our preliminary experimental data, where the maximum pain score postoperatively after caudal block was found to be 2.25 (0.38), assuming that PENG block reduces the pain score with a standard deviation 0.5 and setting a non-inferiority margin of 0.4, we will include a total of 42 participants (N1 = N2 = 21) and achieve an alpha level of set at 0.025 and power of 80%. With a 15% dropout rate, we estimate that the final sample size will be 48 participants (NI = N2 = 24).

Data collection and administration

Each participant’s case report forms (CRFs) will be completed, covering the preoperative, intraoperative, and postoperative periods. Prior to surgery, demographic information (sex, age, height, weight) and baseline characteristics (diagnosis, comorbidities, preoperative medications, allergy history, baseline MAP/HR values) will be gathered. Intraoperative and postoperative data, including vital signs monitoring, medication administration records, and FLACC scores, will be recorded. Withdrawals from the trial will be recorded in the CRFs as well. Two independent research assistants will input the CRFs data into an electronic case report file and double-check the information supplied. Unique numbers are used to distinguish patients in database after follow-up, instead of patient identity information, which is used in statistics analysis and publication. After that, all original data will be coded and safely kept in our archives.

Statistics analysis

A statistician is in charge of data analysis with Statistical Product and Service Solutions (SPSS) Statistics for Windows, version 23.0. The analysis should consider all accessible data, with no exceptions for missing values. Patients with protocol non-adherence, such as those in the intention-to-treat group, will be reported in our research findings, for which intention-to-treat population analysis (ITT) and per-protocol analysis (PP) will be performed. When comparing two groups, normally distributed variables will be represented as mean (standard deviation, SD), while non-normally distributed variables will be provided as median [range]. Continuous variables will be given as mean (SD), whereas categorical variables will be reported as frequency or percentage. The T-test and rank-sum test will be used to compare measurement data between the two groups, while the χ2 test will be used to compare categorical data. The relative risk, as well as the 95% confidence interval (CI), will be determined. The pain score of the primary outcome will be compared between the two groups using repeated measure analysis of variance, with potential post hoc subgroup analyses undertaken if necessary. A significance level of P < 0.05 indicates statistically significant differences between the two groups.

Safety consideration

Regional anesthesia will be provided in the operating room after general anesthesia, with continuous monitoring of vital signs. Any changes in vital signs will be noticed and addressed as soon as possible, and any unforeseen serious incidents related to this study will be reported to both the principal investigator and the hospital patient safety board. We have drawn up contingency plans such as local anesthetic poisoning include detailed therapeutic regimen. Medical costs related to all adverse events are free and the compensation to those who suffer harm will be discussed according to the relevant laws of China.

Discussion

This is a randomized, parallel-group, double-blind, single-center trial designed to assess the safety, efficacy, and feasibility of PENG block as a non-inferior caudal block for perioperative pain management in younger children with developmental dysplasia undergoing hip surgery. Although the PENG block has showed excellent anesthetic outcomes in adults undergoing hip-related surgeries, there is minimal evidence and experience with its use in pediatric patients. To the best of our knowledge, this is the first randomized controlled trial investigating the use of PENG block for anesthesia during hip surgery in children with developmental dysplasia.

Regional anesthesia has garnered considerable attention and respect among pediatric anesthesiologists due to the limitations of pediatric medication. The superior pain relief provided by PENG block can significantly reduce the need for analgesic drugs, particularly opioids, thereby minimizing drug-related side effects. Additionally, consistent observations have been made regarding urinary retention and motor changes in the lower limbs following caudal block. Furthermore, while caudal block may not provide satisfactory analgesia in some older children, it is may well-suited for PENG block. In terms of operative technique, PENG block is performed in a supine position instead of the left decubitus position used for caudal block placement. Moreover, the target position for PENG block is relatively shallow and easily identifiable under ultrasound guidance.

The limitations of this study are small number of patients, single center, single disease, and younger children. Thus, the direction of the next research is expanding the population in different medical center.

Building on prior research, this study aims to validate the suitability of PENG block as an alternative to caudal block in children with DDH undergoing open hip surgery. Our findings will give available evidence that PENG block is safe and effective for perioperative analgesia in pediatric patients undergoing open hip surgery. Furthermore, ongoing studies are investigating its applicability in older children and different diagnostic situations.

Trial status

The current protocol version 1.0 is dated 9.6.2024. The recruitment start date is 18th January 2022 and it is planned to be completed by December 2024. Our study is currently enrolling participants.

Data availability

The full protocol and statistical code used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

PENG:

Pericapsular nerve group

FLACC:

Face, legs, activity, crying, consolability

PCA:

Patient-controlled analgesia

SLIPA:

Streamlined liner of the pharynx airway

DDH:

Developmental dysplasia of the hip

LPB:

Lumbar plexus block

MAC:

Minimum alveolar concentration

BIS:

Bispectral index monitor

ETCO2:

End-tidal carbon dioxide

AIIS:

Anterior inferior iliac spine

IPE:

Iliopubic eminence

IPT:

Iliopsoas tendon

PACU:

Post-anesthesia care unit

CRFs:

Case report forms

SPSS:

Statistical Product and Service Solutions

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Acknowledgements

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Authors and Affiliations

  1. Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China

    Mingzhe Xu,Yi He&Bin Du

  2. The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, China

    Mingzhe Xu,Yi He&Bin Du

  3. Department of Critical Care Medicine, Cheng Du Shang Jin Nan Fu Hospital, West China Hospital of Sichuan University, Chengdu, China

    Zhi Li

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  1. Mingzhe Xu

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  2. Yi He

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Contributions

The trial concept was conceived by MZX and YH, while all authors (MZX, YH, ZL, and BD) participated in. MXZ drafted the manuscript which was subsequently revised by YH and BD. All authors have read and approved the manuscript and agree to be accountable for all aspects of this work.

Corresponding author

Correspondence to Bin Du.

Ethics declarations

Ethics approval and consent to participate

This study protocol is approved by Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (2021-1607). All significant protocol modifications must be approved by the Ethics Committee on Biomedical Research and communicated to relevant parties. The Ethics Committee on Biomedical Research at West China Hospital of Sichuan University will perform audits every 12 months, during which the study progress reports will be reviewed and recommendations for the next research plans will be provided. Guardians provide written, informed consent for their children to participate.

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Not applicable.

Competing interests

None.

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Efficacy and safety of perioperative analgesia in PENG block for children undergoing hip surgery with developmental dysplasia: study protocol for a randomized, double-blinded, non-inferiority trial (2)

Cite this article

Xu, M., He, Y., Li, Z. et al. Efficacy and safety of perioperative analgesia in PENG block for children undergoing hip surgery with developmental dysplasia: study protocol for a randomized, double-blinded, non-inferiority trial. Trials 26, 19 (2025). https://doi.org/10.1186/s13063-025-08725-w

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  • DOI: https://doi.org/10.1186/s13063-025-08725-w

Keywords

  • Perioperative analgesia
  • Pericapsular nerve group block
  • Developmental dysplasia
  • Hip surgery
  • Children
  • Randomized trial
Efficacy and safety of perioperative analgesia in PENG block for children undergoing hip surgery with developmental dysplasia: study protocol for a randomized, double-blinded, non-inferiority trial (2025)
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