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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01075087
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Obesity; Surgery	Drug: Placebo; Drug: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: TAP) Block in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo (control group) will receive sterile normal saline in the block	Drug: Placebo; Bilateral TAP block using sterile normal saline.
Active Comparator: Active comparator (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.	Drug: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.; (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.

Outcome Measures

Primary Outcome Measures

1. Quality of Recovery 40 Score [24 hours post operatively]

   Quality of Recovery 40 Score at 24 hours postoperative.

Secondary Outcome Measures

1. 24 Hour Total Opioid Consumption. [24 hours]

   24 Hour total opioid consumption translated into IV morphine equivalents.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Gildasio DeOliveira, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Alexander CM, Gross JB. Sedative doses of midazolam depress hypoxic ventilatory responses in humans. Anesth Analg. 1988 Apr;67(4):377-82.
• Chung F, Crago RR. Sleep apnoea syndrome and anaesthesia. Can Anaesth Soc J. 1982 Sep;29(5):439-45. Review.
• Dhonneur G, Combes X, Leroux B, Duvaldestin P. Postoperative obstructive apnea. Anesth Analg. 1999 Sep;89(3):762-7.
• 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.
• Kyzer S, Charuzi I. Obstructive sleep apnea in the obese. World J Surg. 1998 Sep;22(9):998-1001. Review.
• Mun EC, Blackburn GL, Matthews JB. Current status of medical and surgical therapy for obesity. Gastroenterology. 2001 Feb;120(3):669-81. Review.
• 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. Review.
• 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.
• 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. Review.
• 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.
• Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. Review.

• Responsible Party: Gildasio De Oliveira, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT01075087
• Other Study ID Numbers: STU00023482
• First Posted: Feb 24, 2010
• Last Update Posted: Jun 26, 2014
• Last Verified: May 1, 2014

• Keywords provided by Gildasio De Oliveira, Principal Investigator, Northwestern University: TAP Block; Pain; Obesity; Surgery; Laparoscopic Banding
• Additional relevant MeSH terms: Obesity; Ropivacaine

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled consecutively from 03/2010 through 07/2012 in the pre operative area of the hospital.
Pre-assignment Detail	26 were assessed for eligibility. 7 were excluded ( 4 did not meet inclusion criteria and 3 refused to participate).

Arm/Group Title	Placebo	Active Comparator
Arm/Group Description	(control group) will receive sterile normal saline in the block Placebo: Bilateral TAP block using sterile normal saline.	(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
Period Title: Overall Study
STARTED	9	10
COMPLETED	9	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Active Comparator	Total
Arm/Group Description	(control group) will receive sterile normal saline in the block Placebo: Bilateral TAP block using sterile normal saline.	(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.	Total of all reporting groups
Overall Participants	9	10	19
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	50	47	48
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 100%	10 100%	19 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	7 77.8%	8 80%	15 78.9%
Male	2 22.2%	2 20%	4 21.1%
Region of Enrollment (participants) [Number]
United States	9 100%	10 100%	19 100%

Outcome Measures

1. Primary Outcome

Title	Quality of Recovery 40 Score
Description	Quality of Recovery 40 Score at 24 hours postoperative.
Time Frame	24 hours post operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator
Arm/Group Description	(control group) will receive sterile normal saline in the block Placebo: Bilateral TAP block using sterile normal saline.	(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
Measure Participants	9	10
Median (Inter-Quartile Range) [units on scale 40 (low) - 200 (high)]	170	175.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Active Comparator
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	-5.5
	Confidence Interval	(2-Sided) 90%; -26 to 3
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	24 Hour Total Opioid Consumption.
Description	24 Hour total opioid consumption translated into IV morphine equivalents.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator
Arm/Group Description	(control group) will receive sterile normal saline in the block Placebo: Bilateral TAP block using sterile normal saline.	(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
Measure Participants	9	10
Median (Inter-Quartile Range) [miligram IV morphine equivalents]	13	7.5

Adverse Events

Arm/Group Title	Placebo		Active Comparator
Arm/Group Description	(control group) will receive sterile normal saline in the block Placebo: Bilateral TAP block using sterile normal saline.		(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
All Cause Mortality
	Placebo		Active Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Active Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Active Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/9 (33.3%)		1/10 (10%)
Gastrointestinal disorders
Nausea	3/9 (33.3%)	3	1/10 (10%)	1
Vomiting	1/9 (11.1%)	1	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.