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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jaime Ortiz, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01204892
First received: September 16, 2010
Last updated: July 11, 2012
Last verified: July 2012

September 16, 2010
July 11, 2012
September 2010
May 2011   (final data collection date for primary outcome measure)
Pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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

Same as current
Complete list of historical versions of study NCT01204892 on ClinicalTrials.gov Archive Site
  • PONV (Postoperative nausea and vomiting) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    PONV events in first 24 hours
  • Narcotics use [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Fentanyl, morphine, and hydrocodone/apap total for 24 hours
Same as current
Not Provided
Not Provided
 
Pain After Laparoscopic Cholecystectomy With Bilateral Tranversus Abdominis Plane (TAP) Block Versus Local Anesthetic Infiltration
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%

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain
  • 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
  • Procedure: 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
  • Active Comparator: TAP Block
    Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia
    Intervention: Procedure: TAP Block
  • Active Comparator: 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
    Intervention: Procedure: Local infiltration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01204892
H-27128
No
Jaime Ortiz, Baylor College of Medicine
Baylor College of Medicine
Not Provided
Principal Investigator: Jaime Ortiz, MD Batylor College of Medicine
Baylor College of Medicine
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP