search
Back to results

Ultrasound Guided Subgluteal Sciatic Nerve Block Versus Caudal Analgesia for Cerebral Palsy Patients Undergoing Lower Limb Corrective Surgeries

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided Subgluteal sciatic nerve block
ultrasound guided Caudal block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient with spastic cerebral palsy Age 2 -12 years Both gender ASA ( American society of anesthesiologists) physical status II Exclusion Criteria: Parents' refusal to study participation. Patients with dyskinetic or ataxic cerebral palsy Patients need surgery for hip contracture/deformity Severe mental dysfunction Poor controlled epilepsy Advanced respiratory,renal or hepatic impairment Allergy to study medications Block contraindication as skin infection near to the block site, gross deformities and bleeding disorders.

Sites / Locations

  • Abassia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ultrasound guided Subgluteal sciatic nerve block group

ultrasound guided Caudal block group

Arm Description

using 0.25% bupivacaine ( 0.3ml/Kg )

using 0.25% bupivacaine ( 1ml/Kg)

Outcomes

Primary Outcome Measures

The time till the first postoperative analgesia demand

Secondary Outcome Measures

Postoperative revised FLACC scores
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Postoperative revised FLACC scores
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Postoperative revised FLACC scores
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Postoperative revised FLACC scores
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Postoperative revised FLACC scores
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Postoperative revised FLACC scores
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Postoperative revised FLACC scores
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Postoperative revised FLACC scores
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Postoperative revised FLACC scores
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Postoperative revised FLACC scores
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Total postoperative paracetamol
total postoperative Ketorolac
number of participants developed complications
The satisfaction of the parents about the postoperative analgesia
parent satisfaction score 1= very unsatisfied 2=unsatisfied 3= satisfied 4= very satisfied

Full Information

First Posted
March 4, 2023
Last Updated
September 27, 2023
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT05774132
Brief Title
Ultrasound Guided Subgluteal Sciatic Nerve Block Versus Caudal Analgesia for Cerebral Palsy Patients Undergoing Lower Limb Corrective Surgeries
Official Title
Ultrasound Guided Subgluteal Sciatic Nerve Block Versus Caudal Analgesia in Pediatric Patients With Spastic Cerebral Palsy Undergoing Lower Limb Multi-level Soft Tissue Corrective Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
September 27, 2023 (Actual)
Study Completion Date
September 27, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Both caudal and peripheral nerve blocks are widely used for postoperative analgesia in pediatric population .The safety of both techniques has been documented especially after the application of ultrasound guidance for their performance. Patients with cerebral palsy usually require lower limb orthopedic surgeries,that extend from minor soft tissue releases, like tenotomies, tendon lengthening or transfer, to major osteotomies for correction of their limb deformities. Study objective: to compare the efficacy of ultrasound guided caudal block with subgluteal sciatic nerve block for postoperative pain control in pediatric patients with cerebral palsy who will undergo soft tissue surgeries for knee and ankle deformities correction. Methods: This study patients will be randomly distributed to 2 Groups to receive either US guided caudal block or US subgluteal sciatic nerve block after induction of general anesthesia.
Detailed Description
After proper preoperative patients' anesthesia assessment; the study patients (15 per each group) will receive general anesthesia with either intravenous induction or inhalational induction if uncooperative under full monitoring of hemodynamics, temperature and oxygen saturation. In caudal group : Patients will be positioned in lateral decubitus and their sacral hiatus will be palpated under the scanning of the ultrasound using high frequency linear probe then approached via 5 cm block needle that pierce the sacrococcygeal ligament then will be advanced to caudal canal under ultrasound guidance after which Marcaine 0.25% (1 ml/kg) will be administered in increments. In subgluteal sciatic group : Patients will be positioned in lateral decubitus and the ultrasound scanning for the sciatic nerve in the subgluteal region will be started between the two bony landmarks (greater trochanter and ischial tuberosity ) using high frequency linear probe then approached via 5 cm block needle under ultrasound guidance after which Marcaine 0.25% (0.3 ml/kg) will be administered in increments . Anesthesia will be maintained with sevoflurane inhalational anesthesia and incremental rocuronium and fentanyl for muscle relaxation and intraoperative analgesia respectively . Muscle relaxation will be reversed at the end of surgery by atropine-neostigmine combination and patients will be extubated fully awake. Postoperative analgesia in the form of intravenous paracetamol 15 mg/kg will be administered if revised FLACC(face,legs,activity,cry and consolability) scores are ≥ 4 and intravenous infusion of ketorolac 0.5 mg/ kg will be given if pain persisted for 15 minutes after paracetamol injection

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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrasound guided Subgluteal sciatic nerve block group
Arm Type
Active Comparator
Arm Description
using 0.25% bupivacaine ( 0.3ml/Kg )
Arm Title
ultrasound guided Caudal block group
Arm Type
Active Comparator
Arm Description
using 0.25% bupivacaine ( 1ml/Kg)
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided Subgluteal sciatic nerve block
Intervention Description
Patients will be positioned in lateral decubitus and the ultrasound scanning for the sciatic nerve in the subgluteal region will be started between the two bony landmarks (greater trochanter and ischial tuberosity ) using high frequency linear probe then approached via 5 cm block needle under ultrasound guidance after which bupivacaine 0.25% (0.3 ml/kg) will be administered in increments .
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided Caudal block
Intervention Description
Patients will be positioned in lateral decubitus and their sacral hiatus will be palpated under the scanning of the ultrasound using high frequency linear probe then approached via 5 cm block needle that pierce the sacrococcygeal ligament then will be advanced to caudal canal under ultrasound guidance after which bupivacaine 0.25% (1 ml/kg) will be administered in increments.
Primary Outcome Measure Information:
Title
The time till the first postoperative analgesia demand
Time Frame
within 24 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative revised FLACC scores
Description
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
2 hours postoperative
Title
Postoperative revised FLACC scores
Description
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
4 hours postoperative
Title
Postoperative revised FLACC scores
Description
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
6 hours postoperative
Title
Postoperative revised FLACC scores
Description
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
8 hours postoperative
Title
Postoperative revised FLACC scores
Description
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
10 hours postoperative
Title
Postoperative revised FLACC scores
Description
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
12 hours postoperative
Title
Postoperative revised FLACC scores
Description
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
15 hours postoperative
Title
Postoperative revised FLACC scores
Description
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
18 hours postoperative
Title
Postoperative revised FLACC scores
Description
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
21 hours postoperative
Title
Postoperative revised FLACC scores
Description
Revised FLACC score ( face,leg,activity, cry and consolability) score Behaviour 0 1 2 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Frequent to constant quivering chin, clenched jow Legs Normal position or relaxed Uneasy, restless, tense Kicking or legs drawn up Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Arched, rigid or jerking Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Crying steadily, screams, sobs, frequent complaints Consolability Content, relaxed Reassured by touching, hugging or being talked to, distractible Difficult to console or comfort 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
24 hours postoperative
Title
Total postoperative paracetamol
Time Frame
one day after surgery
Title
total postoperative Ketorolac
Time Frame
one day after surgery
Title
number of participants developed complications
Time Frame
one day after operation
Title
The satisfaction of the parents about the postoperative analgesia
Description
parent satisfaction score 1= very unsatisfied 2=unsatisfied 3= satisfied 4= very satisfied
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with spastic cerebral palsy Age 2 -12 years Both gender ASA ( American society of anesthesiologists) physical status II Exclusion Criteria: Parents' refusal to study participation. Patients with dyskinetic or ataxic cerebral palsy Patients need surgery for hip contracture/deformity Severe mental dysfunction Poor controlled epilepsy Advanced respiratory,renal or hepatic impairment Allergy to study medications Block contraindication as skin infection near to the block site, gross deformities and bleeding disorders.
Facility Information:
Facility Name
Abassia
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Ultrasound Guided Subgluteal Sciatic Nerve Block Versus Caudal Analgesia for Cerebral Palsy Patients Undergoing Lower Limb Corrective Surgeries

We'll reach out to this number within 24 hrs