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

Phase 3
Completed
Conditions
Gastric-bypass Surgery
Opioid Consumption
Obesity
Interventions
Other: Conventional Managment
Procedure: TAP-Block
Registration Number
NCT01568437
Lead Sponsor
University Health Network, Toronto
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
70
Inclusion Criteria
  • ASA physical status I-III
  • 18-70 years of age, inclusive
  • scheduled for elective laparoscopic gastric-bypass surgery.
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Conventional managementConventional ManagmentOn 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.
TAP Block+Conventional ManagementTAP-BlockThe 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.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Duration of block48 hours

starting after block administration till drop in sensory block injection

Pain scores48 hours

Measured with a visual analogue scale (VAS, from 0 to 10), in the postoperative care unit, at rest and on movement (coughing).

Block procedure time30 minutes

the time from placement of the ultrasound probe on the patient on one side to withdrawal of the needle on the other side;

Opioid consumption at 48 hours48 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

incidence of itching, and number of antipruritic medication administrations48 hours
TAP block complications48 hours

vascular puncture, intravascular local anesthetic injection and local hematoma;

incidence of nausea and vomiting, and number of antiemetic medication administrationsduring hospital stay average of 2 - 3 days

Trial Locations

Locations (1)

Toronto Western Hospital

🇨🇦

Toronto, Ontario, Canada

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