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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: TAP Block; Procedure: Local infiltration

• Registration Number: NCT01204892
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-11
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patient ages 18-64
2. American Society of Anesthesiology Physical Status I, II or III
3. Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital

Exclusion Criteria

1. Open cholecystectomy - excluded due to increased levels of pain in open procedures
2. Scheduled for ambulatory surgery
3. Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
4. Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection
5. Allergy or contraindication to any of the study medications or anesthetic agents
6. Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
7. Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
8. Pregnancy
9. Prisoners
10. Patient or surgeon refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAP Block	TAP Block	Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia
Local infiltration	Local infiltration	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

Primary Outcome Measures

Name	Time	Method
Pain	24 hours	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

Secondary Outcome Measures

Name	Time	Method
PONV (Postoperative nausea and vomiting)	24 hours	PONV events in first 24 hours
Narcotics use	24 hours	Fentanyl, morphine, and hydrocodone/apap total for 24 hours

Trial Locations

Locations (1)

Ben Taub General Hospital; 🇺🇸 Houston, Texas, United States