Trocar-site Infiltration Versus TAP-block

Sponsor

Tunis University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05094193

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

24.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Cholecystectomy	Procedure: Trocar-site infiltration Procedure: TAP block Procedure: Trocar site infiltration placebo Procedure: TAP block placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Trocar-site Infiltration With Ropivacaine Versus Tranversus Abdominis Plane Block Following Laparoscopic Cholecystectomy: a Double-blinded, Randomized-controlled Trial

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trocar-site infiltration 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	Procedure: Trocar-site infiltration 20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 6 mm trocar site) Procedure: TAP block placebo bilateral ultrasound-guided TAP block with 20 mL of normal saline in each side
Active Comparator: TAP block Trocar-site infiltration with 20 mL of normal saline associated with bilateral TAP block with 20 mL of ropivacaine 0.375% in each side	Procedure: TAP block bilateral ultrasound-guided TAP block with 20 mL of ropivacaine 0.375% in each side Procedure: Trocar site infiltration placebo 20 mL of normal saline

Arm

Intervention/Treatment

Experimental: Trocar-site infiltration

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

Procedure: Trocar-site infiltration

20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 6 mm trocar site)

Procedure: TAP block placebo

bilateral ultrasound-guided TAP block with 20 mL of normal saline in each side

Active Comparator: TAP block

Trocar-site infiltration with 20 mL of normal saline associated with bilateral TAP block with 20 mL of ropivacaine 0.375% in each side

Procedure: TAP block

bilateral ultrasound-guided TAP block with 20 mL of ropivacaine 0.375% in each side

Procedure: Trocar site infiltration placebo

20 mL of normal saline

Outcome Measures

Primary Outcome Measures

Acute postoperative pain [up to 24 hours]
Visual analog scale (VAS) 0: "no pain" to 10: "severe pain" at rest and cough
Total opioid consumption [Day 1]

Secondary Outcome Measures

Length of hospital stay [up to 1 week]
postoperative nausea and vomiting [Day 1]
Patient satisfaction and quality of recovery [Day 1]
QoR-40 questionnaire
Incidence of shoulder pain [Day 1]
Postoperative complication [up to 1 week]
Ileus, wound infection, wound abscess

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

BMI < 30 kg/m2
Scheduled for laparoscopic cholecystectomy
ASA grade I, II and III

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Habib Thameur Hospital	Tunis		Tunisia

Sponsors and Collaborators

Tunis University

Investigators

Study Director: BEN FADHEL Kamel, M.D, Habib Thameur Hospital of Tunis, Department of Anesthesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daghmouri Mohamed Aziz, Principal investigator, Tunis University

ClinicalTrials.gov Identifier:

NCT05094193

Other Study ID Numbers:

HTHEC-2021-29

First Posted:

Oct 26, 2021

Last Update Posted:

Oct 26, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Daghmouri Mohamed Aziz, Principal investigator, Tunis University

Acute pain management

Ropivacaine

Trocar-site infiltration

TAP-block

Laparoscopic cholecystectomy

Study Results

No Results Posted as of Oct 26, 2021