Comparison of Ultrasound Guided Erector Spinae Plane Block and Ultrasound Guided Pericapsular Nerve Group Block for Pediatric Hip Surgery

November 23, 2022 updated by: tarek abdel hay mostafa, Tanta University
Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia. The reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization. Regional anesthetic techniques seem to be a better choice for improving acute pain management in these patients, with fewer adverse effects.

Study Overview

Detailed Description

Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia. The reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization.

Regional anesthetic techniques seem to be a better choice for improving acute pain management in these patients, with fewer adverse effects. The erector spinae block is a recently described ultrasound-guided technique in which local anesthetics is injected into a fascial plane between the tips of the thoracic transverse processes and the overlying erector spinae muscle (longissimus thoracis).

Pericapsular nerve group (PENG) block has been recently recommended by Girón-Arango et al. for use as postoperative analgesia in hip surgeries. It is a new regional anesthesia technique in the region between the anterior inferior iliac spine (AIIS) and ilio-pubic eminence (IPE).

The anterior capsule is the most richly innervated section of the joint suggesting these nerves should be the main targets for hip analgesia.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • El Gharbyia
      • Tanta, El Gharbyia, Egypt, 31527
        • Tarek Abdel Hay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children of both genders
  • American Society of Anaestheologists (ASA) physical activity I, II
  • aged more than one year
  • admitted for elective pediatric hip surgery

Exclusion Criteria:

  • Children with severe systemic disease with American Society of Anaestheologists (ASA) III or IV,
  • children with previous neurological or spinal disorders,
  • coagulation disorder,
  • infection at the block injection site,
  • history of allergy to local anesthetics
  • bilateral hip surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ESP group
Under ultrasound guidance, patients of this group will receive (0.5ml/kg) plain bupivacaine 0.25%with adrenaline 2.5 µg/ml injected beneath the erector spinae muscle sheath at the level of the transverse process of the second lumbar vertebrae
the patient will be placed in the lateral position with the surgical side up for performing erector spinae plane block. After skin preparation, superficial (5-12 MHz) ultrasound transducer will be placed in a longitudinal orientation 1-2cm lateral to the midline at the sacral level. The L2 level will be identified by counting upward from the sacrum. Following identification of the erector spinae muscle (ESM) and transverse process, a 21 G needle will be inserted deep to the erector spinae muscle (ESM) in a cranio-caudal direction. After negative aspiration, the correct needle position will be confirmed with the administration of 0.5-1ml LA. A total volume of 0.5 mL/kg local anesthetic solution will be injected interfascial plane between erector spinae muscle and transverse process for block performance.
EXPERIMENTAL: PENG group
Under ultrasound guidance, patients of this group will receive (0.5ml/kg) plain bupivacaine 0.25%with adrenaline 2.5 µg/ml injected as the tip of the needle in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly
the patient will be in supine position. The ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be visualized using a linear ultrasound probe. A 22-gauge, 50-mm needle will be introduced in a lateral to medial fashion in an in-plane approach to place the tip of the needle in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, a total volume of 0.5 mL/kg local anesthetic solution will be injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first rescue analgesic demand
Time Frame: postoperative first day
Time to first rescue analgesic requirement: measured from the end of surgery till patient require analgesia.
postoperative first day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total doses of intraoperative fentanyl consumption
Time Frame: intraoperative
Total doses of intraoperative fentanyl consumption
intraoperative
Total analgesic consumption
Time Frame: postoperative first day
Total analgesic consumption If pain score more than 3, the child will be given intravenous morphine as rescue analgesia will be given in a dose 0.1mg/kg.
postoperative first day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2020

Primary Completion (ACTUAL)

September 1, 2022

Study Completion (ACTUAL)

October 1, 2022

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

May 1, 2020

First Posted (ACTUAL)

May 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 23, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ESP block and PENG block

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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