Post Operative Pain, AcuteNCT05493085
Quadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients for Upper Abdominal Surgeries
A study testing Quadratus lumborum block and Caudal epidural injection in people with Post Operative Pain, Acute, run by Ain Shams University at 1 site in Egypt.
Trial summary
Compare between the analgesic effect of the Ultrasound-guided quadratus lumborum block and single Caudal epidural injection in pediatric patients undergoing surgeries with supraumbilical incisions. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- Quadratus lumborum block and Caudal epidural injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2022to Mar 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any pediatric patient aged from 2 to 8 years undergoing abdominal Surgery with Supraumbilical umbilical incision
Who cannot join
- parents refusal to participate in the study,
- previous history of allergy to local anesthetics
- hemodynamic instability
- Coagulopathy,
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university hospital
Cairo, Abbasia, 11213
Mohamed A Tolba, MD, 01156622298 ext. 002, Mohamedtolba@med.asu.edu.eg
Aya H Moussa, MD, 01114555939 ext. 002, Ayahisham@med.asu.edu.eg
About this study
Official title: Quadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients Undergoing Upper Abdominal Surgeries.
Compare between the analgesic effect of the Ultrasound-guided quadratus lumborum block and single Caudal epidural injection in pediatric patients undergoing surgeries with supraumbilical incisions.
- Conditions
- Post Operative Pain, Acute
- Being tested
- Quadratus lumborum block, Caudal epidural injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum blockProcedure or surgery
Ultrasound-guided quadratus lumborum block
Caudal epidural injectionProcedure or surgery
Single Caudal epidural injection
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum | Active comparator | Patients will receive Ultrasound-guided quadratus lumborum block Receives: Procedure: Quadratus lumborum block |
| Caudal epidural | Active comparator | Patients will receive single Caudal epidural injection Receives: Procedure: Caudal epidural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Face, leg, activity, cry and consolability score With score of 0 meaning no pain and requires no intervention and score of 10 indicating the worst imaginable pain requiring rescue analgesia
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start15 Jun 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherif Wadei, MD, Study chair, AinShams University, Anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493085
- Sponsor's protocol ID
- FMASU R 69/2022
- Status last verified
- Jan 2023
- First submitted
- 1 Jun 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients Undergoing Upper Abdominal Surgeries.
- ClinicalTrials.gov ID
- NCT05493085
- Acronym / sponsor ID
- FMASU R 69/2022
- Conditions
- Post Operative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 9 Aug 2022 (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.
Compare between the analgesic effect of the Ultrasound-guided quadratus lumborum block and single Caudal epidural injection in pediatric patients undergoing surgeries with supraumbilical incisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum | Active comparator | Procedure: Quadratus lumborum blockPatients will receive Ultrasound-guided quadratus lumborum block |
| Caudal epidural | Active comparator | Procedure: Caudal epidural injectionPatients will receive single Caudal epidural injection |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any pediatric patient aged from 2 to 8 years undergoing abdominal Surgery with Supraumbilical umbilical incision
Key exclusion criteria (4 listed)
- parents refusal to participate in the study,
- previous history of allergy to local anesthetics
- hemodynamic instability
- Coagulopathy,
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 |
|---|---|---|
| Quadratus lumborum blockUltrasound-guided quadratus lumborum block | Procedure or surgery | Quadratus Lumborum |
| Caudal epidural injectionSingle Caudal epidural injection | Procedure or surgery | Caudal epidural |
Primary outcome
Pain score
Time frame: 24 hours postoperative
Face, leg, activity, cry and consolability score With score of 0 meaning no pain and requires no intervention and score of 10 indicating the worst imaginable pain requiring rescue analgesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Sherif Wadei, MD study chair
AinShams University, Anesthesia department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus lumborum block and Caudal epidural injection in people with Post Operative Pain, Acute, 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Tolba, MD (0020 115 6622298, Mohamedtolba@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 24 hours postoperative). 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 20 Jan 2023.