Trocar-site Infiltration Versus TAP-block

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.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Procedure: Trocar-site infiltration; Procedure: TAP block placebo; Procedure: TAP block; Procedure: Trocar site infiltration placebo

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DAGHMOURI Mohamed Aziz, M.D; Phone Number: 0029442474; Email: aziz.daghmouri@gmail.com

Study Locations

• Tunisia
  • Tunis, Tunisia
    • Recruiting
    • Habib Thameur Hospital
    • Contact: Mohamed Aziz Daghmouri; Email: aziz.daghmouri@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: October 3, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Laparoscopic cholecystectomy; Ropivacaine; TAP-block; Acute pain management; Trocar-site infiltration
• Other Study ID Numbers: HTHEC-2021-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No