Laparoscopic CholecystectomyNCT05094193
Trocar-site Infiltration Versus TAP-block
A study testing Trocar-site infiltration and TAP block in people with Laparoscopic Cholecystectomy, run by Tunis University at 1 site in Tunisia.
Trial summary
For symptomatic gall bladder disorders (cholelithiasis and cholecystitis), laparoscopic cholecystectomy (LC) has been considered as the gold standard treatment. However, these minimally invasive technique is associated with acute moderate pain during the 24 hours postoperative, which is routinely managed using… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Trocar-site infiltration and TAP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Oct 2021to 31 Jan 2022
- 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
- BMI < 30 kg/m2
- Scheduled for laparoscopic cholecystectomy
- ASA grade I, II and III
Who cannot join
- Bile duct exploration, insertion of a T-drain or patients with acute cholecystitis
- Conversion to open cholecystectomy or if the surgery exceeded 200 minutes
- Severe systemic disease
- Patients on analgesics for any reason
- History of allergy to local anesthetics
- An ongoing pregnancy
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Habib Thameur Hospital
Tunis
Mohamed Aziz Daghmouri, aziz.daghmouri@gmail.com
About this study
Official title: Trocar-site Infiltration With Ropivacaine Versus Tranversus Abdominis Plane Block Following Laparoscopic Cholecystectomy: a Double-blinded, Randomized-controlled Trial
For symptomatic gall bladder disorders (cholelithiasis and cholecystitis), laparoscopic cholecystectomy (LC) has been considered as the gold standard treatment. However, these minimally invasive technique is associated with acute moderate pain during the 24 hours postoperative, which is routinely managed using opioids. The transversus abdominis plane (TAP) block has been used as part of a multimodal analgesia strategy. Besides, Wang et al found that TAP block is more effective than a conventional pain control, but not significatively different from another local incisional pain control that is port site infiltration.So, the aim of this study, is to compare the analgesic efficacy and safety of trocar-site infiltration with ropivacaine with ultrasound-guided TAP block following laparoscopic cholecystectomy when used as part of multimodal analgesia.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Trocar-site infiltration, TAP block, Trocar site infiltration placebo, TAP block placebo
- Keywords
- Acute pain management, Ropivacaine, Trocar-site infiltration, TAP-block, Laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trocar-site infiltrationProcedure or surgery
20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 6 mm trocar site)
TAP blockProcedure or surgery
bilateral ultrasound-guided TAP block with 20 mL of ropivacaine 0.375% in each side
Trocar site infiltration placeboProcedure or surgery
20 mL of normal saline
TAP block placeboProcedure or surgery
bilateral ultrasound-guided TAP block with 20 mL of normal saline in each side
| Study group | Role | What they receive |
|---|---|---|
| Trocar-site infiltration | Experimental | Trocar-site infiltration with 20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 5 mm trocar site) associated with bilateral TAP block with 20 mL of normal saline in each side Receives: Procedure: Trocar-site infiltration; Procedure: TAP block placebo |
| TAP block | Active comparator | Trocar-site infiltration with 20 mL of normal saline associated with bilateral TAP block with 20 mL of ropivacaine 0.375% in each side Receives: Procedure: TAP block; Procedure: Trocar site infiltration placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute postoperative pain
Visual analog scale (VAS) 0: "no pain" to 10: "severe pain" at rest and cough
Measured: up to 24 hours
Total opioid consumption
Measured: Day 1
Secondary outcomes (5)
Length of hospital stay
Measured: up to 1 week
postoperative nausea and vomiting
Measured: Day 1
Patient satisfaction and quality of recovery
QoR-40 questionnaire
Measured: Day 1
Incidence of shoulder pain
Measured: Day 1
Postoperative complication
Ileus, wound infection, wound abscess
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tunis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daghmouri Mohamed Aziz, Tunis University
- Investigators
- BEN FADHEL Kamel, M.D, Study director, Habib Thameur Hospital of Tunis, Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094193
- Sponsor's protocol ID
- HTHEC-2021-29
- Status last verified
- Oct 2021
- First submitted
- 3 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trocar-site Infiltration With Ropivacaine Versus Tranversus Abdominis Plane Block Following Laparoscopic Cholecystectomy: a Double-blinded, Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT05094193
- Acronym / sponsor ID
- HTHEC-2021-29
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- Acute pain management, Ropivacaine, Trocar-site infiltration, TAP-block, Laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tunis UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 26 Oct 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.
For symptomatic gall bladder disorders (cholelithiasis and cholecystitis), laparoscopic cholecystectomy (LC) has been considered as the gold standard treatment. However, these minimally invasive technique is associated with acute moderate pain during the 24 hours postoperative, which is routinely managed using opioids. The transversus abdominis plane (TAP) block has been used as part of a multimodal analgesia strategy. Besides, Wang et al found that TAP block is more effective than a conventional pain control, but not significatively different from another local incisional pain control that is port site infiltration.So, the aim of this study, is to compare the analgesic efficacy and safety of trocar-site infiltration with ropivacaine with ultrasound-guided TAP block following laparoscopic cholecystectomy when used as part of multimodal analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trocar-site infiltration | Experimental | Procedure: Trocar-site infiltration, Procedure: TAP block placeboTrocar-site infiltration with 20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 5 mm trocar site) associated with bilateral TAP block with 20 mL of normal saline in each side |
| TAP block | Active comparator | Procedure: TAP block, Procedure: Trocar site infiltration placeboTrocar-site infiltration with 20 mL of normal saline associated with bilateral TAP block with 20 mL of ropivacaine 0.375% in each side |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI < 30 kg/m2
- Scheduled for laparoscopic cholecystectomy
- ASA grade I, II and III
Key exclusion criteria (7 listed)
- Bile duct exploration, insertion of a T-drain or patients with acute cholecystitis
- Conversion to open cholecystectomy or if the surgery exceeded 200 minutes
- Severe systemic disease
- Patients on analgesics for any reason
- History of allergy to local anesthetics
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 |
|---|---|---|
| Trocar-site infiltration20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 6 mm trocar site) | Procedure or surgery | Trocar-site infiltration |
| TAP blockbilateral ultrasound-guided TAP block with 20 mL of ropivacaine 0.375% in each side | Procedure or surgery | TAP block |
| Trocar site infiltration placebo20 mL of normal saline | Procedure or surgery | TAP block |
| TAP block placebobilateral ultrasound-guided TAP block with 20 mL of normal saline in each side | Procedure or surgery | Trocar-site infiltration |
Primary outcome
Acute postoperative pain
Time frame: up to 24 hours
Visual analog scale (VAS) 0: "no pain" to 10: "severe pain" at rest and cough
Total opioid consumption
Time frame: Day 1
5 secondary outcomes
Length of hospital stay
Time frame: up to 1 week
postoperative nausea and vomiting
Time frame: Day 1
Patient satisfaction and quality of recovery
Time frame: Day 1
Incidence of shoulder pain
Time frame: Day 1
Postoperative complication
Time frame: up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
BEN FADHEL Kamel, M.D study director
Habib Thameur Hospital of Tunis, Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trocar-site infiltration and TAP block in people with Laparoscopic Cholecystectomy, run by Tunis University at 1 site in Tunisia.
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 7 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 26 Oct 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 Tunisia. 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 DAGHMOURI Mohamed Aziz, M.D (0029442474, aziz.daghmouri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute postoperative pain (time frame: up to 24 hours). The study lists 2 primary outcomes in all. 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 26 Oct 2021; AzTrials last refreshed its copy on 30 Oct 2026.