Pain After Laparoscopic Cholecystectomy With Bilateral Tranversus Abdominis Plane (TAP) Block Versus Local Anesthetic Infiltration

Study Overview
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Brief Summary
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The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy. Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.

Detailed Description
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The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy. Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.

Official Title
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Postoperative Pain After Laparoscopic Cholecystectomy in Patients Receiving Bilateral Ultrasound-guided Transverse Abdominis Plane Block Compared With Local Anesthetic Infiltration of Trochar Insertion Sites With Ropivacaine 0.5%

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: TAP Block
* Procedure: Local infiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ages 18-64 American Society of Anesthesiology Physical Status I, II or III Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital Exclusion Criteria: Open cholecystectomy - excluded due to increased levels of pain in open procedures Scheduled for ambulatory surgery Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection Allergy or contraindication to any of the study medications or anesthetic agents Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder) Pregnancy Prisoners Patient or surgeon refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP Block<br>Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia | Procedure: TAP Block<br>* Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia<br>|
| Active Comparator: Local infiltration<br>20 ml of Ropivacaine 0.5% will be injected at port sites after induction of general anesthesia. 7 ml each for 10 mm ports, 3 ml each of 5 mm ports | Procedure: Local infiltration<br>* 20 ml of Ropivacaine 0.5% will be injected at port sites after induction of general anesthesia. 7 ml each for 10 mm ports, 3 ml each of 5 mm ports<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain scores on NAS scale (0-10) at the following times: Preop, Time 0, Time 1, Time 2, Time 4, Time 8, Time 12, Time 24 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PONV (Postoperative nausea and vomiting) | PONV events in first 24 hours | 24 hours | 
| Narcotics use | Fentanyl, morphine, and hydrocodone/apap total for 24 hours | 24 hours |