Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Pediatric Hip Surgery

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05460442
Collaborator
(none)
75
1
3
12.5
6

Study Details

Study Description

Brief Summary

This compares the postoperative analgesic effect of ultrasound-guided pericapsular nerve group block (PENG) with ultrasound-guided fascia iliaca compartment block in pediatric patients undergoing hip surgery.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Caudal Block group
  • Procedure: Pericapsular nerve group block
  • Procedure: Fascia iliaca group
N/A

Detailed Description

Surgeries involving hip joints in pediatric patients are associated with severe intraoperative and postoperative pain despite the use of systemic opioids.

Caudal block is the most commonly used method of regional anesthesia in children to control intraoperative and postoperative pain in surgeries involving lower limbs. However, there have been many side effects of caudal block such as hypotension, urine retention, excessive motor block, technical failure, nausea, and vomiting which may limit its use.

There are several techniques of ultrasound-guided regional anesthesia that are used to control acute pain in hip surgery with fewer side effects such as a lumbar plexus block, femoral nerve block, or a fascia iliaca compartment block.

The fascia iliaca compartment block (FICB) was described in 1989. It remains a popular regional anesthetic technique for surgical procedures involving the hip joint and femur. Local anesthetic (LA) is injected proximally beneath the fascia iliaca to block the femoral nerve (FN), obturator nerve (ON), and lateral cutaneous nerve of the thigh (LCNT) simultaneously.

The pericapsular nerve group (PENG) block was introduced to block the articular branches of the femoral, obturator, and accessory obturator nerves which provide sensory innervation to the hip. This regional anesthetic technique was described in 2018 for acute analgesia related to hip fractures.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Ultrasound-Guided Pericapsular Nerve Group Block Versus Ultrasound-Guided Fascia Iliaca Block for Pediatric Hip Surgery
Actual Study Start Date :
Jul 15, 2022
Anticipated Primary Completion Date :
Jul 20, 2023
Anticipated Study Completion Date :
Jul 29, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Caudal Block group

25 patients will receive ultrasound-guided caudal block with bupivacaine 0.25% (0.5 mL/kg) after induction of anesthesia.

Procedure: Caudal Block group
Patients will be placed in the lateral decubitus position. After local sterilization with povidone-iodine, the sacral hiatus will be visualized at the level of the sacral Cornus by ultrasound. The needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament. At this level, after confirming the absence of blood or cerebrospinal fluid on aspiration, bupivacaine 0.25% (0.5 mL/kg) will be injected over 1 minute

Experimental: Pericapsular nerve group block

25 patients will receive ipsilateral ultrasound-guided Pericapsular nerve group block with bupivacaine 0.25% (0.5 mL/kg) after induction of anesthesia.

Procedure: Pericapsular nerve group block
Patients will receive ultrasound-guided Pericapsular nerve group block in the supine position after proper sterilization of the groin region. The needle will be inserted in-plane with the transducer. The Pericapsular nerve group block group will receive 0.5 mL/kg of (0.25%) bupivacaine after a negative aspiration

Experimental: Fascia iliaca group

25 patients will receive ipsilateral ultrasound-guided Fascia iliaca compartment block with bupivacaine 0.25% (0.5 m. L/kg) after induction of anesthesia.

Procedure: Fascia iliaca group
Patients will receive Ultrasound-Guided fascia iliaca compartment block in the supine position after sterilization of groin area. The needle will be inserted in-plane with the transducer. The needle tip will be advanced through the fascia iliaca and inserted further cephalad just below the fascia iliaca into the iliacus muscle. 0.5 mL/kg of (0.25%) bupivacaine will be injected and visualized moving cephalad away from the needle tip

Outcome Measures

Primary Outcome Measures

  1. Total Opioids consumption [24 hours postoperatively]

    Total Opioids consumption in first 24 hour postoperatively will be recorded

Secondary Outcome Measures

  1. Postoperative pain [At post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours.]

    Postoperative pain which will be assessed by face, legs, activity, and cry consolability scale [FLACC]

  2. Time to first rescue analgesia [24 hours Postoperatively]

    Time of administration of first rescue analgesia will be recorded.

  3. Adverse effects [24 hours Postoperatively]

    Adverse effects: hypotension, Bradycardia, hematoma, and local anesthetic toxicity will be observed and treated accordingly.

  4. Heart rate [Intraoperative then at post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours]

    Perioperative heart rate will be observed

  5. Mean arterial blood pressure [Intraoperative then at post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours.]

    Perioperative mean arterial blood pressure will be observed

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Pediatric patients

  • aged 1-6 years old

  • both sexes,

  • American Society of Anesthesiologists (ASA) physical activity class I-II

  • scheduled for elective hip surgery under general anesthesia.

Exclusion Criteria:
  • Children with the severe systemic disease with American Society of Anesthesiologists physical activity class III or IV.

  • Children with previous neurological or spinal disorders.

  • Coagulation disorder.

  • Infection at the block injection site.

  • History of allergy to local anesthetics.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta University hospitals Tanta Egypt

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Elsaied Mohamed Hosny Alam, Resident of Anesthesiology and Surgical Intensive Care and Pain Medicine, Tanta University
ClinicalTrials.gov Identifier:
NCT05460442
Other Study ID Numbers:
  • 35436/4/22
First Posted:
Jul 15, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 19, 2022