Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery
|ClinicalTrials.gov Identifier: NCT01568437|
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : December 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastric-bypass Surgery Opioid Consumption Obesity||Procedure: TAP-Block Other: Conventional Managment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Is the Analgesic Effect of the Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery Useful?|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||March 2013|
Active Comparator: Conventional management
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.
Other: Conventional Managment
For these group.no TAP block administration. just conventional management for post operative pain.
Experimental: TAP Block+Conventional Management
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.
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.
- Opioid consumption over the first 24 hours following LGBS. [ Time Frame: 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.
- Pain scores [ Time Frame: 48 hours ]Measured with a visual analogue scale (VAS, from 0 to 10), in the postoperative care unit, at rest and on movement (coughing).
- Opioid consumption at 48 hours [ Time Frame: 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
- Duration of block [ Time Frame: 48 hours ]starting after block administration till drop in sensory block injection
- Block procedure time [ Time Frame: 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;
- TAP block complications [ Time Frame: 48 hours ]vascular puncture, intravascular local anesthetic injection and local hematoma;
- incidence of nausea and vomiting, and number of antiemetic medication administrations [ Time Frame: during hospital stay average of 2 - 3 days ]
- incidence of itching, and number of antipruritic medication administrations [ Time Frame: 48 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568437
|Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T2S8|
|Principal Investigator:||Richard Brull, MD, FRCPC||University of Toronto. University Health Network. Toronto Western Hospital.|