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

NCT01075087 | Completed Results

• 1 other identifier: STU00023482
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Obesity; Surgery

Keywords

TAP Block; Pain; Obesity; Surgery; Laparoscopic Banding

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery 40 Score

  Quality of Recovery 40 Score at 24 hours postoperative.

  24 hours post operatively

Secondary Outcomes (1)

• 24 Hour Total Opioid Consumption.

  24 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

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.

Interventions

Placebo DRUG

Bilateral TAP block using sterile normal saline.

Placebo

(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.

Active comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (11)

• 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.

  PMID: 11179243 BACKGROUND

• 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.

  PMID: 6691724 BACKGROUND

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

  PMID: 9717428 BACKGROUND

• 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.

  PMID: 8652329 BACKGROUND

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

  PMID: 3354874 BACKGROUND

• 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.

  PMID: 10475322 BACKGROUND

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

  PMID: 6751498 BACKGROUND

• 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.

  PMID: 19700053 BACKGROUND

• 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.

  PMID: 10718794 BACKGROUND

• 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.

  PMID: 10910857 BACKGROUND

• 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.

  PMID: 11703235 BACKGROUND

MeSH Terms

Conditions

Pain; Obesity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Results Point of Contact

• Title: Gildasio De Oliveira MD,MS
• Organization: Northwestern University

g-jr@northwestern.edu

312-472-3573

Study Officials

• Gildasio DeOliveira, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 24, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 26, 2014
• Results First Posted: June 26, 2014

Record last verified: 2014-05

Locations

US (1)