Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery

NCT01568437 | Completed Phase 3

• 1 other identifier: 11-0869-B
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic gastric-bypass surgery (LGBS) is one of the surgical treatments for morbid obesity, which is performed under general anesthesia. TAP block is an analgesic strategy covering the dermatomes from T6 to L1 and consists of injecting local anesthetic in the TAP between the costal margin and the iliac crest, where the thoracolumbar nerves (T6-L1) are located. As far as the investigators know, this analgesic technique has never been studied in LGBS. The investigators objective is to determine whether an ultrasound (US)-guided TAP block provides improved analgesia during the first 24 hours after laparoscopic gastric-bypass surgery, compared to conventional therapy only.

Conditions

Gastric-bypass Surgery; Opioid Consumption; Obesity

Keywords

Laparoscopic gastric-bypass surgery; TAP block

Outcome Measures

Primary Outcomes (1)

• Opioid consumption over the first 24 hours following LGBS.

  Opioid consumption will be expressed in terms of milligrams doses of PO morphine. If other opioids are used, doses will be converted to the equivalent PO morphine dose using standard opioid dosage conversion tables.

  24 hrs

Secondary Outcomes (7)

• Pain scores

  48 hours

• Opioid consumption at 48 hours

  48 Hours

• Duration of block

  48 hours

• Block procedure time

  30 minutes

• TAP block complications

  48 hours

Study Arms (2)

Conventional management

ACTIVE COMPARATOR

On the ward, patients will be prescribed acetaminophen 1 g every 6 hours. If additional analgesia is required, patients will take oxycodone 5-10 mg up to every 2 hours or iv morphine. Patients with contraindications to oxycodone will be prescribed oral hydromorphone 1-2 mg instead. This is the current standard of care at Toronto Western Hospital.

Other: Conventional Managment

TAP Block+Conventional Management

EXPERIMENTAL

The TAP block will be performed after the induction, before the surgery, by an anesthesiologist with experience of at least 10 successful TAP blocks.Also patients will be prescribed acetaminophen 1 g every 6 hours. If additional analgesia is required, patients will take oxycodone 5-10 mg(oral hydromorphone 1-2 mg) up to every 2 hours or iv morphine.

Procedure: TAP-Block

Interventions

TAP-Block PROCEDURE

Block needle will be inserted out-of-plane to the ultrasound beam, perpendicular to the skin surface, until the tip lies deep between the fascia of the transversus abdominis muscle and the internal oblique muscle. 30 ml of the study solution in each side will be injected at this location and should be observed to spread in an anterior-posterior direction between two muscles. Each patient will receive a total dose of 60 ml of 0.25% bupivacaine (150 mg) + 1:200,000 epinephrine.

TAP Block+Conventional Management

Conventional Managment OTHER

For these group.no TAP block administration. just conventional management for post operative pain.

Conventional management

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-III
• years of age, inclusive
• scheduled for elective laparoscopic gastric-bypass surgery.

You may not qualify if:

• contraindications to regional blockade (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
• pregnancy
• history of alcohol or drug dependence/abuse
• history of long term opioid intake or chronic pain disorder
• history of significant psychiatric conditions that may affect patient assessment
• inability to understand the informed consent and demands of the study

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard Brull, MD, FRCPC

  University of Toronto. University Health Network. Toronto Western Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

CA (1)