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

NCT04373577 | Completed DMC

• 1 other identifier: ESP block and PENG block
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Time to first rescue analgesic demand

  Time to first rescue analgesic requirement: measured from the end of surgery till patient require analgesia.

  postoperative first day

Secondary Outcomes (2)

• Total doses of intraoperative fentanyl consumption

  intraoperative

• Total analgesic consumption

  postoperative first day

Study Arms (2)

ESP group

EXPERIMENTAL

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

Procedure: erector spinae plane block

PENG group

EXPERIMENTAL

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

Procedure: pericapsular nerve group block

Interventions

erector spinae plane block PROCEDURE

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.

ESP group

pericapsular nerve group block PROCEDURE

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.

PENG group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tarek Abdel Hay

Tanta, El Gharbyia, 31527, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 4, 2020
• Study Start: May 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Locations

EG (1)