Trocar-site Infiltration Versus TAP-block

Tunis University

Status: Unknown

Conditions: Laparoscopic Cholecystectomy

Treatments: Procedure: TAP block placebo; Procedure: Trocar site infiltration placebo; Procedure: Trocar-site infiltration; Procedure: TAP block

Study type: Interventional

Funder types: Other

Identifiers

NCT05094193

HTHEC-2021-29

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Trocar-site infiltration

Experimental group

Description:

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

Treatment:

Procedure: TAP block placebo

Procedure: Trocar-site infiltration

TAP block

Active Comparator group

Description:

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

Treatment:

Procedure: TAP block

Procedure: Trocar site infiltration placebo