Transversus Abdominis PlaneNCT06345248
Laparoscopic-assisted Versus Ultrasonography-guided Transversus Abdominis Plane Block in Laparoscopic Sleeve Gastrectomy
A study testing US-TAP and LAPTAP in people with Transversus Abdominis Plane, run by Cairo University at 1 site in Egypt.
Trial summary
The transversus abdominis plane (TAP) block, whereby local anesthetic is injected between the internal oblique and transversus abdominis fascia to facilitate blockade of somatic afferents nerves, is an effective, non-narcotic adjunct incorporated into many ERAS protocols. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transversus Abdominis Plane
- What is being tested?
- US-TAP and LAPTAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 May 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective laparoscopic sleeve gastrectomy aging > 18years BMI > 40 kg/m2, ASA score I-III
Who cannot join
- history of chronic opioid consumption suffering from contraindications to regional blocks suffering from allergy to study drugs, history of prior complex abdominal wall reconstruction
Trial locations and contacts
1 site in 1 country.
About this study
The transversus abdominis plane (TAP) block, whereby local anesthetic is injected between the internal oblique and transversus abdominis fascia to facilitate blockade of somatic afferents nerves, is an effective, non-narcotic adjunct incorporated into many ERAS protocols. We hypothesized that surgeon delivered LAP-TAPs would be non-inferior to anesthesia-delivered US-TAPs in terms of post-operative pain control
- Conditions
- Transversus Abdominis Plane
- Being tested
- US-TAP, LAPTAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-TAPProcedure or surgery
regional block team under ultrasound guidance
LAPTAPProcedure or surgery
performed TAP block under direct visualization with the laparoscope
| Study group | Role | What they receive |
|---|---|---|
| US-TAP group | Active comparator | Not described Receives: Procedure: US-TAP |
| LAPTAP group | Active comparator | Not described Receives: Procedure: LAPTAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine needed
mg
Measured: UP TO 24 HOURE
Secondary outcomes (3)
first analgesic request time
he time elapsed between the end of the operation till the first analgesic dose
Measured: up to 24 hours
patients' satisfaction
scale of 1-4 (1, poor; 2, acceptable; 3, satisfactory; and 4, excellent)
Measured: UP TO 24 HOURE
opioid-associated side effects
bradycardia and hypotesion
Measured: UP TO 24 HOURE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transversus Abdominis PlaneStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345248
- Sponsor's protocol ID
- 2024-854
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Still working
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic-assisted Versus Ultrasonography-guided Transversus Abdominis Plane Block in Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT06345248
- Acronym / sponsor ID
- 2024-854
- Conditions
- Transversus Abdominis Plane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 3 Apr 2024 (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 transversus abdominis plane (TAP) block, whereby local anesthetic is injected between the internal oblique and transversus abdominis fascia to facilitate blockade of somatic afferents nerves, is an effective, non-narcotic adjunct incorporated into many ERAS protocols. We hypothesized that surgeon delivered LAP-TAPs would be non-inferior to anesthesia-delivered US-TAPs in terms of post-operative pain control
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-TAP group | Active comparator | Procedure: US-TAP |
| LAPTAP group | Active comparator | Procedure: LAPTAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective laparoscopic sleeve gastrectomy aging > 18years BMI > 40 kg/m2, ASA score I-III
Key exclusion criteria (1 listed)
- history of chronic opioid consumption suffering from contraindications to regional blocks suffering from allergy to study drugs, history of prior complex abdominal wall reconstruction
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 |
|---|---|---|
| US-TAPregional block team under ultrasound guidance | Procedure or surgery | US-TAP group |
| LAPTAPperformed TAP block under direct visualization with the laparoscope | Procedure or surgery | LAPTAP group |
Primary outcome
morphine needed
Time frame: UP TO 24 HOURE
mg
3 secondary outcomes
first analgesic request time
Time frame: up to 24 hours
patients' satisfaction
Time frame: UP TO 24 HOURE
opioid-associated side effects
Time frame: UP TO 24 HOURE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Undecided. Still working
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COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTS OF ULTRASOUND-GUIDED QUADRO-ILIAC PLANE AND TRANSVERSUS ABDOMINIS PLANE BLOCKS IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY
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COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
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Subcostal TAP Block Versus Combined Subcostal TAP and Recto-Intercostal Fascial Plane Block for Analgesia After Laparoscopic Cholecystectomy
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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 US-TAP and LAPTAP in people with Transversus Abdominis Plane, run by Cairo 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 1 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 3 Apr 2024. 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?
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?
morphine needed (time frame: UP TO 24 HOURE). 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 3 Apr 2024.