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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT01568437

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Is the Analgesic Effect of the Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery Useful?

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Opioid consumption over the first 24 hours following LGBS. [24 hrs]
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 [48 hours]
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 [48 Hours]
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 [48 hours]
starting after block administration till drop in sensory block injection
Block procedure time [30 minutes]
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 [48 hours]
vascular puncture, intravascular local anesthetic injection and local hematoma;
incidence of nausea and vomiting, and number of antiemetic medication administrations [during hospital stay average of 2 - 3 days]
incidence of itching, and number of antipruritic medication administrations [48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Western Hospital	Toronto	Ontario	Canada	M5T2S8

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator: Richard Brull, MD, FRCPC, University of Toronto. University Health Network. Toronto Western Hospital.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT01568437

Other Study ID Numbers:

11-0869-B

First Posted:

Apr 2, 2012

Last Update Posted:

Dec 9, 2015

Last Verified:

Dec 1, 2015

Keywords provided by University Health Network, Toronto

Laparoscopic gastric-bypass surgery

TAP block

Study Results

No Results Posted as of Dec 9, 2015