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Trocar-site Infiltration Versus TAP-block

NCT05094193 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-10-26

No results posted yet for this study

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.

Conditions

  • Laparoscopic Cholecystectomy

Interventions

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

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

PROCEDURE

TAP block placebo

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

Sponsors & Collaborators

  • Tunis University

    lead OTHER

Principal Investigators

  • BEN FADHEL Kamel, M.D · Habib Thameur Hospital of Tunis, Department of Anesthesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2021-12-31
Completion
2022-01-31

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05094193 on ClinicalTrials.gov