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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01568437
First received: March 29, 2012
Last updated: March 30, 2012
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Gastric-bypass Surgery
Opioid Consumption
Obesity
Procedure: TAP-Block
Other: Conventional Managment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Is the Analgesic Effect of the Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery Useful?

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Opioid consumption over the first 24 hours following LGBS. [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pain scores [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Measured with a visual analogue scale (VAS, from 0 to 10), in the postoperative care unit, at rest and on movement (coughing).

  • Opioid consumption at 48 hours [ Time Frame: 48 Hours ] [ Designated as safety issue: No ]
    Opioid consumption expressed as milligram doses of PO morphine in the postoperative care unit and at 48 hours.If other opioids are used, doses will be converted to the equivalent PO morphine dose using standard opioid dosage conversion tables

  • Duration of block [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    starting after block administration till drop in sensory block injection

  • Block procedure time [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    the time from placement of the ultrasound probe on the patient on one side to withdrawal of the needle on the other side;

  • TAP block complications [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    vascular puncture, intravascular local anesthetic injection and local hematoma;

  • incidence of nausea and vomiting, and number of antiemetic medication administrations [ Time Frame: during hospital stay average of 2 - 3 days ] [ Designated as safety issue: No ]
  • incidence of itching, and number of antipruritic medication administrations [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: January 2012
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Other: Conventional Managment
For these group.no TAP block administration. just conventional management for post operative pain.
Experimental: 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.
Procedure: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568437

Contacts
Contact: Kris Abbas, M.D 4166035800 ext 6237 KRIS.ABBAS@UHN.CA

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T2S8
Sub-Investigator: Eric Albrecht, MD,DEAA         
Sub-Investigator: Kyle Kirkham, MD         
Sub-Investigator: Faraj Abdallah, MD         
Sub-Investigator: Sherif Abbas, MD         
Sub-Investigator: Timothy Jackson, MD, FRCSC         
Sub-Investigator: Allan Okrainec, MD, FRCSC         
Sub-Investigator: Todd Penner, MD, FRCSC         
Sub-Investigator: Vincent Chan, MD, FRCPC         
Principal Investigator: Richard Brull, MD, FRCPC         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Richard Brull, MD, FRCPC University of Toronto. University Health Network. Toronto Western Hospital.
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01568437     History of Changes
Other Study ID Numbers: 11-0869-B
Study First Received: March 29, 2012
Last Updated: March 30, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Laparoscopic gastric-bypass surgery
TAP block

ClinicalTrials.gov processed this record on September 16, 2014