Trocar-site Infiltration Versus TAP-block

Study Overview
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Brief Summary
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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.

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

Conditions
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Laparoscopic Cholecystectomy

Intervention / Treatment
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* Procedure: Trocar-site infiltration
* Procedure: TAP block
* Procedure: Trocar site infiltration placebo
* Procedure: TAP block placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute pain management, Ropivacaine, Trocar-site infiltration, TAP-block, Laparoscopic cholecystectomy