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

N/ACompletedNCT01204892

Baylor College of Medicine80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postoperative Pain

Interventions

TAP BlockPROCEDURE

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

Local infiltrationPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Ben Taub General Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

PONV (Postoperative nausea and vomiting)

PONV events in first 24 hours

Time frame: 24 hours

Narcotics use

Fentanyl, morphine, and hydrocodone/apap total for 24 hours

Time frame: 24 hours

Data from ClinicalTrials.gov

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