Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery
- Conditions
- Gastric-bypass SurgeryOpioid ConsumptionObesity
- Interventions
- Other: Conventional ManagmentProcedure: 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
- ASA physical status I-III
- 18-70 years of age, inclusive
- scheduled for elective laparoscopic gastric-bypass surgery.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Conventional management Conventional Managment 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. TAP Block+Conventional Management TAP-Block 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Duration of block 48 hours starting after block administration till drop in sensory block injection
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).
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;
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
incidence of itching, and number of antipruritic medication administrations 48 hours 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
Trial Locations
- Locations (1)
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada