Postoperative AnalgesiaPhase 4NCT04720287
Ultrasound Guided Quadratus Lumborum Block Compared to Caudal Bupivacaine/ Neostigmine in Pediatric Lower Abdominal Surgeries
A Phase 4 study testing bupivacaine/ neostigmine. in people with Postoperative Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the postoperative pain control in children undergoing lower abdominal surgeries receiving QL block with those receiving caudal bupivacaine/ neostigmine. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- bupivacaine/ neostigmine.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 30 Apr 2021
- Phase
- Phase 4
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients American Society of Anesthesiologists physical status (ASA) I or II.
- Consent from parents or legal guardian(s).
- Lower abdominal surgeries.
Who cannot join
- Parents' refusal or legal guardian's refusal.
- Infection at the injection site.
- Known allergy to bupivacaine and/or neostigmine.
- Contraindications to regional anesthesia (including coagulopathy and local infection).
- Anatomical anomalies at the site of the block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Quadratus Lumborum Block Compared to Caudal Bupivacaine/ Neostigmine in Pediatric Lower Abdominal Surgeries, a Randomized Controlled Trial
The aim of this study is to compare the postoperative pain control in children undergoing lower abdominal surgeries receiving QL block with those receiving caudal bupivacaine/ neostigmine.
- Conditions
- Postoperative Analgesia
- Being tested
- bupivacaine/ neostigmine.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine/ neostigmine.Drug
will receive bilateral ultrasound guided QLB
bupivacaine/ neostigmine.Drug
will receive ultrasound guided CB.
| Study group | Role | What they receive |
|---|---|---|
| Group 1(QL group) | Active comparator | Not described Receives: Drug: bupivacaine/ neostigmine. |
| Group 2 (CB group) | Active comparator | Not described Receives: Drug: bupivacaine/ neostigmine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total amount of paracetamol doses (mg)
The total amount of paracetamol doses (mg)
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Feb 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720287
- Sponsor's protocol ID
- FMASU MS 728/2020/2021
- Status last verified
- May 2021
- First submitted
- 19 Jan 2021
- Last updated
- 27 May 2021
- Results posted
- No
- 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 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Quadratus Lumborum Block Compared to Caudal Bupivacaine/ Neostigmine in Pediatric Lower Abdominal Surgeries, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04720287
- Acronym / sponsor ID
- FMASU MS 728/2020/2021
- Conditions
- Postoperative Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 22 Jan 2021 (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.
The aim of this study is to compare the postoperative pain control in children undergoing lower abdominal surgeries receiving QL block with those receiving caudal bupivacaine/ neostigmine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1(QL group) | Active comparator | Drug: bupivacaine/ neostigmine. |
| Group 2 (CB group) | Active comparator | Drug: bupivacaine/ neostigmine. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients American Society of Anesthesiologists physical status (ASA) I or II.
- Consent from parents or legal guardian(s).
- Lower abdominal surgeries.
Key exclusion criteria (5 listed)
- Parents' refusal or legal guardian's refusal.
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 |
|---|---|---|
| bupivacaine/ neostigmine.will receive bilateral ultrasound guided QLB | Drug | Group 1(QL group) |
| bupivacaine/ neostigmine.will receive ultrasound guided CB. | Drug | Group 2 (CB group) |
Primary outcome
The total amount of paracetamol doses (mg)
Time frame: 24 hours postoperatively
The total amount of paracetamol doses (mg)
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 27 May 2021.
- 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.
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 Phase 4 study testing bupivacaine/ neostigmine. in people with Postoperative Analgesia, 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 3 inclusion and 5 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 27 May 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 total amount of paracetamol doses (mg) (time frame: 24 hours postoperatively). 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 27 May 2021.