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

Baylor College of Medicine

Status: Completed

Conditions: Postoperative Pain

Treatments: Procedure: Local infiltration; Procedure: TAP Block

Study type: Interventional

Funder types: Other

Identifiers

NCT01204892

H-27128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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80 participants in 2 patient groups

TAP Block

Active Comparator group

Description:

Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia

Treatment:

Procedure: TAP Block

Local infiltration

Active Comparator group

Description:

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

Treatment:

Procedure: Local infiltration