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

NCT ID: NCT01568437

Last Updated: 2015-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional management

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.

Group Type: ACTIVE_COMPARATOR

Conventional Managment

Intervention Type: OTHER

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

TAP Block+Conventional Management

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.

Group Type: EXPERIMENTAL

TAP-Block

Intervention Type: 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.

Interventions

TAP-Block

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.

Intervention Type: PROCEDURE

Conventional Managment

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ASA physical status I-III
• 18-70 years of age, inclusive
• scheduled for elective laparoscopic gastric-bypass surgery.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Brull, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

11-0869-B

Identifier Type: -

Identifier Source: org_study_id