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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568437
• Other study ID #: 11-0869-B
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2012
• Last updated: December 7, 2015
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric-bypass Surgery
• Obesity
• Opioid Consumption

Intervention

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.

Other:
• Conventional Managment
For these group.no TAP block administration. just conventional management for post operative pain.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain scores	Measured with a visual analogue scale (VAS, from 0 to 10), in the postoperative care unit, at rest and on movement (coughing).	48 hours	No
Secondary	Opioid consumption at 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	48 Hours	No
Secondary	Duration of block	starting after block administration till drop in sensory block injection	48 hours	No
Secondary	Block procedure time	the time from placement of the ultrasound probe on the patient on one side to withdrawal of the needle on the other side;	30 minutes	No
Secondary	TAP block complications	vascular puncture, intravascular local anesthetic injection and local hematoma;	48 hours	Yes
Secondary	incidence of nausea and vomiting, and number of antiemetic medication administrations		during hospital stay average of 2 - 3 days	No
Secondary	incidence of itching, and number of antipruritic medication administrations		48 hours	No