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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01568437
Other study ID # 11-0869-B
Secondary ID
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


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
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