Clinical trial NCT01204892: Pain After Laparoscopic Cholecystectomy With Bilateral Tranversus Abdominis Plane (TAP) Block Versus Local Anesthetic Infiltration
Official title: 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%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2010-09-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: 24 hours
Secondary outcomes:
measure: PONV (Postoperative nausea and vomiting)
timeFrame: 24 hours
measure: Narcotics use
timeFrame: 24 hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
Study officials:
affiliation: Batylor College of Medicine
name: Jaime Ortiz, MD
role: PRINCIPAL_INVESTIGATOR
References: