Postoperative PainNCT05774132
Ultrasound Guided Subgluteal Sciatic Nerve Block Versus Caudal Analgesia for Cerebral Palsy Patients Undergoing Lower Limb Corrective Surgeries
A study testing ultrasound guided Subgluteal sciatic nerve block and ultrasound guided Caudal block in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ultrasound guided Subgluteal sciatic nerve block and ultrasound guided Caudal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2023to 27 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient with spastic cerebral palsy
- Age 2 -12 years
- Both gender
- ASA ( American society of anesthesiologists) physical status II
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Postoperative Pain
- Being tested
- ultrasound guided Subgluteal sciatic nerve block, ultrasound guided Caudal block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided Subgluteal sciatic nerve blockProcedure or surgery
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 .
ultrasound guided Caudal blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided Subgluteal sciatic nerve block group | Active comparator | using 0.25% bupivacaine ( 0.3ml/Kg ) Receives: Procedure: ultrasound guided Subgluteal sciatic nerve block |
| ultrasound guided Caudal block group | Active comparator | using 0.25% bupivacaine ( 1ml/Kg) Receives: Procedure: ultrasound guided Caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time till the first postoperative analgesia demand
Measured: within 24 hours after surgery
Secondary outcomes (14)
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
Measured: 2 hours postoperative
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
Measured: 4 hours postoperative
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
Measured: 6 hours postoperative
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
Measured: 8 hours postoperative
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
Measured: 10 hours postoperative
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
Measured: 12 hours postoperative
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
Measured: 15 hours postoperative
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
Measured: 18 hours postoperative
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
Measured: 21 hours postoperative
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
Measured: 24 hours postoperative
Total postoperative paracetamol
Measured: one day after surgery
total postoperative Ketorolac
Measured: one day after surgery
number of participants developed complications
Measured: one day after operation
The satisfaction of the parents about the postoperative analgesia
parent satisfaction score 1= very unsatisfied 2=unsatisfied 3= satisfied 4= very satisfied
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start20 Mar 2023
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany magdy fahim, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774132
- Sponsor's protocol ID
- FMASU R24/ 2023
- Status last verified
- Sep 2023
- First submitted
- 4 Mar 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05774132
- Acronym / sponsor ID
- FMASU R24/ 2023
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided Subgluteal sciatic nerve block group | Active comparator | Procedure: ultrasound guided Subgluteal sciatic nerve blockusing 0.25% bupivacaine ( 0.3ml/Kg ) |
| ultrasound guided Caudal block group | Active comparator | Procedure: ultrasound guided Caudal blockusing 0.25% bupivacaine ( 1ml/Kg) |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient with spastic cerebral palsy
- Age 2 -12 years
- Both gender
- ASA ( American society of anesthesiologists) physical status II
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound guided Subgluteal sciatic nerve blockPatients 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 . | Procedure or surgery | ultrasound guided Subgluteal sciatic nerve block group |
| ultrasound guided Caudal blockPatients 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. | Procedure or surgery | ultrasound guided Caudal block group |
Primary outcome
The time till the first postoperative analgesia demand
Time frame: within 24 hours after surgery
14 secondary outcomes
Postoperative revised FLACC scores
Time frame: 2 hours postoperative
Postoperative revised FLACC scores
Time frame: 4 hours postoperative
Postoperative revised FLACC scores
Time frame: 6 hours postoperative
Postoperative revised FLACC scores
Time frame: 8 hours postoperative
Postoperative revised FLACC scores
Time frame: 10 hours postoperative
Postoperative revised FLACC scores
Time frame: 12 hours postoperative
Postoperative revised FLACC scores
Time frame: 15 hours postoperative
Postoperative revised FLACC scores
Time frame: 18 hours postoperative
Postoperative revised FLACC scores
Time frame: 21 hours postoperative
Postoperative revised FLACC scores
Time frame: 24 hours postoperative
Total postoperative paracetamol
Time frame: one day after surgery
total postoperative Ketorolac
Time frame: one day after surgery
number of participants developed complications
Time frame: one day after operation
The satisfaction of the parents about the postoperative analgesia
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided Subgluteal sciatic nerve block and ultrasound guided Caudal block in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time till the first postoperative analgesia demand (time frame: within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.