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Completed

NCT Number: NCT01568437

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

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.

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Key information

Conditions

Gastric-bypass Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Opioid Consumption Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAP-Block

Procedure

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.

Conventional Managment

Other

For these group.no TAP block administration. just conventional management for post operative pain.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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

  3. Duration of block

    Time frame: 48 hours

    starting after block administration till drop in sensory block injection

  4. 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;

  5. TAP block complications

    Time frame: 48 hours

    vascular puncture, intravascular local anesthetic injection and local hematoma;

  6. incidence of nausea and vomiting, and number of antiemetic medication administrations

    Time frame: during hospital stay average of 2 - 3 days

  7. incidence of itching, and number of antipruritic medication administrations

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Is the Analgesic Effect of the Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery Useful?

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 2, 2012
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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