Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Transversus abdominis plane (TAP) block has gained popularity for the control of postoperative pain in various surgeries. Three studies showed inconsistent result on pain control after TAP block in laparoscopic cholecystectomy. The TAP technique used in these studies was classic ultrasound guided TAP block. Besides periumbilical incision, sub-xiphoid incision is usually made during laparoscopic cholecystectomy. As typical posterior TAP rarely extend above T8, the investigators undergo subcostal TAP block for this type of surgery. The investigators are going to investigate the effect of subcostal TAP on early postoperative pain after laparoscopic cholecystectomy.

Official Title
-----------------
Effect of Subcostal Transversus Abdominis Plane Block on Early Postoperative Pain in Laparoscopic Cholecystectomy: Randomized, Controlled Trial

Conditions
-----------------
Laparoscopic Cholecystectomy, Postoperative Pain, Abdominal Muscles, Nerve Block

Intervention / Treatment
-----------------
* Procedure: Ultrasound guided subcostal TAP block
* Procedure: Placebo Ultrasound guided subcostal TAP block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II Age 20-65 patients scheduled elective laparoscopic cholecystectomy Exclusion Criteria: Patient refusal Allergy to ropivacaine Coagulopathy Morbid obesity (BMI>35 kg/m2) Previous abdominal surgery.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Control group receiving saline instead of ropivacaine | Procedure: Placebo Ultrasound guided subcostal TAP block<br>* Under ultrasound guidance saline 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.<br>|
| Experimental: TAP<br>TAP group receiving ropivacaine total of 150 mg at TAP under US | Procedure: Ultrasound guided subcostal TAP block<br>* Under ultrasound guidance0.375% ropivacaine 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (NRS) 15 min after entering recovery room |  | 15 min after entering recovery room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl consumption at recovery room |  | Up to 3 hours until discharge from recovery room | 
| Recovery room stay |  | Up to 3 hours from entering recovery room to discharge | 
| Incidence of postoperative nausea and vomiting (PONV) |  | Up to 3 hours during recovery room stay | 
| NRS at 4h, 24h, and 48 h after surgery |  | 4h, 24h, and 48 h after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic cholecystectomy, ultrasound, transversus abdominis plane block