Cholecystitis; GallstoneNCT04276285
Laparoscopic Versus US-Guided Subcostal TAP Block After Laparoscopic Cholecystectomy
A study testing Laparoscopic TAP and US TAP in people with Cholecystitis; Gallstone, run by Mansoura University at 1 site in Egypt.
Trial summary
Zaghiyan et al hypothesized that Laparoscopic TAP was noninferior to US-TAP and performed a randomized clinical trial comparing Laparoscopic TAP, US-TAP, and no TAP in minimally invasive colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholecystitis; Gallstone
- What is being tested?
- Laparoscopic TAP and US TAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Feb 2020to 30 Mar 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive adult patients of either gender who will undergo laparoscopic cholecystectomy will be recruited to the study.
Who cannot join
- Pregnant women
- Patients who will undergo open cholecystectomy
- Patients who will need conversion to conventional open cholecystectomy
- Patients with ASA III classification or higher
- Patients who will undergo laparoscopic cholecystectomy together with other abdominal interventions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516
Sameh Emile, M.D, 01006267150, sameh200@hotmail.com
Sameh H Emile, M.D.
About this study
Official title: Impact of Laparoscopic Versus Ultrasound-Guided Subcostal Transversus Abdominis Plane Block on Pain and Recovery After Laparoscopic Cholecystectomy: A Randomized Double-Blinded Controlled Study
Zaghiyan et al hypothesized that Laparoscopic TAP was noninferior to US-TAP and performed a randomized clinical trial comparing Laparoscopic TAP, US-TAP, and no TAP in minimally invasive colorectal surgery. The authors reported that LTAP was superior to UTAP in achieving pain control and minimizing opioid use in the first 24 hours after colorectal surgery.
This prospective randomized, controlled trial will be performed to assessed the efficacy of laparoscopic subcostal TAP block (LSTAP) compared to ultrasound-guided subcostal TAP (USTAP) block after laparoscopic cholecystectomy regarding postoperative pain scores in the first 24-hours after the intervention and analgesic requirements.
- Conditions
- Cholecystitis; Gallstone
- Being tested
- Laparoscopic TAP, US TAP
- Medical subject headings
- Cholecystitis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic TAPProcedure or surgery
Subcostal TAP block will be performed after surgery under laparoscopic guidance
US TAPProcedure or surgery
Subcostal TAP block will be performed after surgery under US guidance
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic TAP | Active comparator | Subcostal TAP block will be performed after surgery under laparoscopic guidance Receives: Procedure: Laparoscopic TAP |
| US TAP | Active comparator | Subcostal TAP block will be performed after surgery under ultrasound guidance Receives: Procedure: US TAP |
| No TAP | No intervention | No TAP block will be performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
pain will be assessed with visual analogue scale from 0-10
Measured: 24 hours after cholecystectomy
Secondary outcomes (1)
Analgesic requirement
the need for intravenous analgesia after surgery calculated as the cumulative dose of analgesic administered over 24 hours
Measured: 24 hours after cholecystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start17 Feb 2020
- Primary completion28 Feb 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis; GallstoneStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh H Emile, M.D., Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276285
- Sponsor's protocol ID
- Mansoura124
- Status last verified
- Aug 2020
- First submitted
- 17 Feb 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- 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 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Laparoscopic Versus Ultrasound-Guided Subcostal Transversus Abdominis Plane Block on Pain and Recovery After Laparoscopic Cholecystectomy: A Randomized Double-Blinded Controlled Study
- ClinicalTrials.gov ID
- NCT04276285
- Acronym / sponsor ID
- Mansoura124
- Conditions
- Cholecystitis; Gallstone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 19 Feb 2020 (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.
Zaghiyan et al hypothesized that Laparoscopic TAP was noninferior to US-TAP and performed a randomized clinical trial comparing Laparoscopic TAP, US-TAP, and no TAP in minimally invasive colorectal surgery. The authors reported that LTAP was superior to UTAP in achieving pain control and minimizing opioid use in the first 24 hours after colorectal surgery.
This prospective randomized, controlled trial will be performed to assessed the efficacy of laparoscopic subcostal TAP block (LSTAP) compared to ultrasound-guided subcostal TAP (USTAP) block after laparoscopic cholecystectomy regarding postoperative pain scores in the first 24-hours after the intervention and analgesic requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic TAP | Active comparator | Procedure: Laparoscopic TAPSubcostal TAP block will be performed after surgery under laparoscopic guidance |
| US TAP | Active comparator | Procedure: US TAPSubcostal TAP block will be performed after surgery under ultrasound guidance |
| No TAP | No intervention | –No TAP block will be performed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive adult patients of either gender who will undergo laparoscopic cholecystectomy will be recruited to the study.
Key exclusion criteria (5 listed)
- Pregnant women
- Patients who will undergo open cholecystectomy
- Patients who will need conversion to conventional open cholecystectomy
- Patients with ASA III classification or higher
- Patients who will undergo laparoscopic cholecystectomy together with other abdominal interventions.
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 |
|---|---|---|
| Laparoscopic TAPSubcostal TAP block will be performed after surgery under laparoscopic guidance | Procedure or surgery | Laparoscopic TAP |
| US TAPSubcostal TAP block will be performed after surgery under US guidance | Procedure or surgery | US TAP |
Primary outcome
Pain score
Time frame: 24 hours after cholecystectomy
pain will be assessed with visual analogue scale from 0-10
1 secondary outcome
Analgesic requirement
Time frame: 24 hours after cholecystectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- 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.
Sameh H Emile, M.D. principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic TAP and US TAP in people with Cholecystitis; Gallstone, run by Mansoura 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 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: status not confirmed, as of the sponsor's last update on 20 Aug 2020. 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 Sameh H Emile, M.D. (+201006267150, sameh200@hotmail.com), 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 after cholecystectomy). 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 Aug 2020.