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

University Health Network, Toronto

Status and phase: Completed; Phase 3

Conditions: Opioid Consumption; Obesity; Gastric-bypass Surgery

Treatments: Procedure: TAP-Block; Other: Conventional Managment

Study type: Interventional

Funder types: Other

Identifiers

NCT01568437

11-0869-B

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Conventional management

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Managment

TAP Block+Conventional Management

Experimental group

Description:

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.

Treatment:

Procedure: TAP-Block