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

NCT ID: NCT01075087

Last Updated: 2014-06-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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Conditions

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Pain Obesity Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Bilateral TAP block using sterile normal saline.

Active comparator

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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Placebo

Bilateral TAP block using sterile normal saline.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Gildasio De Oliveira

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gildasio DeOliveira, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11179243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6691724 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 9717428 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8652329 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3354874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10475322 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 6751498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19700053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10718794 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10910857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11703235 (View on PubMed)

Other Identifiers

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STU00023482

Identifier Type: -

Identifier Source: org_study_id

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