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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
erector spinae plane block
pericapsular nerve group block
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

1 Year - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tarek Abdel Hay

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ESP group

PENG group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total doses of intraoperative fentanyl consumption
Total doses of intraoperative fentanyl consumption
Total analgesic consumption
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.

Full Information

First Posted
April 28, 2020
Last Updated
November 23, 2022
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04373577
Brief Title
Comparison of Ultrasound Guided Erector Spinae Plane Block and Ultrasound Guided Pericapsular Nerve Group Block for Pediatric Hip Surgery
Official Title
Comparison of Ultrasound Guided Erector Spinae Plane Block and Ultrasound Guided Pericapsular Nerve Group Block for Pediatric Hip Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP group
Arm Type
Experimental
Arm Description
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
Arm Title
PENG group
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
erector spinae plane block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
pericapsular nerve group block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to first rescue analgesic demand
Description
Time to first rescue analgesic requirement: measured from the end of surgery till patient require analgesia.
Time Frame
postoperative first day
Secondary Outcome Measure Information:
Title
Total doses of intraoperative fentanyl consumption
Description
Total doses of intraoperative fentanyl consumption
Time Frame
intraoperative
Title
Total analgesic consumption
Description
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.
Time Frame
postoperative first day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tarek Abdel Hay
City
Tanta
State/Province
El Gharbyia
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

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

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