Trocar-site Infiltration Versus TAP-block

Overview

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.

Full Title of Study: “Trocar-site Infiltration With Ropivacaine Versus Tranversus Abdominis Plane Block Following Laparoscopic Cholecystectomy: a Double-blinded, Randomized-controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2021

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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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
    • QoR-40 questionnaire
  • Incidence of shoulder pain
    • Time Frame: Day 1
  • Postoperative complication
    • Time Frame: up to 1 week
    • Ileus, wound infection, wound abscess

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tunis University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Daghmouri Mohamed Aziz, Principal investigator – Tunis University
  • Overall Official(s)
    • BEN FADHEL Kamel, M.D, Study Director, Habib Thameur Hospital of Tunis, Department of Anesthesia
  • Overall Contact(s)
    • DAGHMOURI Mohamed Aziz, M.D, 0029442474, aziz.daghmouri@gmail.com

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