Obesity Clinical Trial
Official title:
Is the Analgesic Effect of the Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery Useful?
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Toronto Western Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
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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