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The Effect of Pre-Operative Transversus Abdominis Plane (TAP) Block in the Post Operative Opioid Consumption in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study

Primary Purpose

Pain, Obesity, Surgery

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Placebo

(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.

About this trial

This is an interventional prevention trial for Pain focused on measuring TAP Block, Pain, Obesity, Surgery, Laparoscopic Banding

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: 18-65 years
BMI >35 Kg/m2
Surgery: laparoscopic gastric bypass surgery
ASA status: I, II and III
Fluent in English

Exclusion Criteria:

History of allergy to local anesthetics
Chronic opioid use
Pregnant patients
Patients who remained intubated after surgery

Drop-out criteria:

Patient or surgeon request Complications related to the procedure or conversion to open route Patient requiring mechanical ventilation after surgery

Sites / Locations

Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Active comparator

Arm Description

(control group) will receive sterile normal saline in the block

(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.

Outcomes

Primary Outcome Measures

Quality of Recovery 40 Score

Quality of Recovery 40 Score at 24 hours postoperative.

Secondary Outcome Measures

24 Hour Total Opioid Consumption.

24 Hour total opioid consumption translated into IV morphine equivalents.

Full Information

NCT ID

NCT01075087

First Posted

February 23, 2010

Last Updated

May 23, 2014

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT01075087

Brief Title

The Effect of Pre-Operative Transversus Abdominis Plane (TAP) Block in the Post Operative Opioid Consumption in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study

Official Title

TAP) Block in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The use of preoperative TAP block in laparoscopic bariatric surgery can improve the postoperative pain and quality of recovery in patients undergoing these procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Obesity, Surgery

Keywords

TAP Block, Pain, Obesity, Surgery, Laparoscopic Banding

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

(control group) will receive sterile normal saline in the block

Arm Title

Active comparator

Arm Type

Active Comparator

Arm Description

(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Bilateral TAP block using sterile normal saline.

Intervention Type

Drug

Intervention Name(s)

(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.

Intervention Description

(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.

Primary Outcome Measure Information:

Title

Quality of Recovery 40 Score

Description

Quality of Recovery 40 Score at 24 hours postoperative.

Time Frame

24 hours post operatively

Secondary Outcome Measure Information:

Title

24 Hour Total Opioid Consumption.

Description

24 Hour total opioid consumption translated into IV morphine equivalents.

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 18-65 years BMI >35 Kg/m2 Surgery: laparoscopic gastric bypass surgery ASA status: I, II and III Fluent in English Exclusion Criteria: History of allergy to local anesthetics Chronic opioid use Pregnant patients Patients who remained intubated after surgery Drop-out criteria: Patient or surgeon request Complications related to the procedure or conversion to open route Patient requiring mechanical ventilation after surgery

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gildasio DeOliveira, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11179243

Citation

Mun EC, Blackburn GL, Matthews JB. Current status of medical and surgical therapy for obesity. Gastroenterology. 2001 Feb;120(3):669-81. doi: 10.1053/gast.2001.22430.

Results Reference

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PubMed Identifier

6691724

Citation

Peiser J, Lavie P, Ovnat A, Charuzi I. Sleep apnea syndrome in the morbidly obese as an indication for weight reduction surgery. Ann Surg. 1984 Jan;199(1):112-5. doi: 10.1097/00000658-198401000-00020.

Results Reference

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PubMed Identifier

9717428

Citation

Kyzer S, Charuzi I. Obstructive sleep apnea in the obese. World J Surg. 1998 Sep;22(9):998-1001. doi: 10.1007/s002689900506.

Results Reference

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PubMed Identifier

8652329

Citation

Rosenberg-Adamsen S, Kehlet H, Dodds C, Rosenberg J. Postoperative sleep disturbances: mechanisms and clinical implications. Br J Anaesth. 1996 Apr;76(4):552-9. doi: 10.1093/bja/76.4.552. No abstract available.

Results Reference

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PubMed Identifier

3354874

Citation

Alexander CM, Gross JB. Sedative doses of midazolam depress hypoxic ventilatory responses in humans. Anesth Analg. 1988 Apr;67(4):377-82.

Results Reference

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PubMed Identifier

10475322

Citation

Dhonneur G, Combes X, Leroux B, Duvaldestin P. Postoperative obstructive apnea. Anesth Analg. 1999 Sep;89(3):762-7. doi: 10.1097/00000539-199909000-00045.

Results Reference

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PubMed Identifier

6751498

Citation

Chung F, Crago RR. Sleep apnoea syndrome and anaesthesia. Can Anaesth Soc J. 1982 Sep;29(5):439-45. doi: 10.1007/BF03009406.

Results Reference

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PubMed Identifier

19700053

Citation

Passannante AN, Tielborg M. Anesthetic management of patients with obesity with and without sleep apnea. Clin Chest Med. 2009 Sep;30(3):569-79, x. doi: 10.1016/j.ccm.2009.05.009.

Results Reference

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PubMed Identifier

10718794

Citation

Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. doi: 10.1046/j.1365-2168.2000.01374.x.

Results Reference

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PubMed Identifier

10910857

Citation

Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032.

Results Reference

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PubMed Identifier

11703235

Citation

Shaw IC, Stevens J, Krishnamurthy S. The influence of intraperitoneal bupivacaine on pain following major laparoscopic gynaecological procedures. Anaesthesia. 2001 Nov;56(11):1041-4. doi: 10.1046/j.1365-2044.2001.02215.x.

Results Reference

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