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

Postoperative Pain Clinical Trial

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%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204892
• Other study ID #: H-27128
• Status: Completed
• Phase: N/A
• First received: September 16, 2010
• Last updated: July 11, 2012
• Start date: September 2010
• Est. completion date: May 2011

Study information

• Verified date: July 2012
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• 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
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

Locations

Country	Name	City	State
United States	Ben Taub General Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	PONV (Postoperative nausea and vomiting)	PONV events in first 24 hours	24 hours	No
Secondary	Narcotics use	Fentanyl, morphine, and hydrocodone/apap total for 24 hours	24 hours	No