Gastric-bypass Surgery, Obesity, Opioid Consumption
Conditions
Keywords
Laparoscopic gastric-bypass surgery, TAP block
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.
Interventions
PROCEDURETAP-Block
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.
OTHERConventional Managment
For these group.no TAP block administration. just conventional management for post operative pain.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
| Duration of block | 48 hours | starting after block administration till drop in sensory block injection |
| 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; |
| incidence of nausea and vomiting, and number of antiemetic medication administrations | during hospital stay average of 2 - 3 days | — |
| 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; |
Countries
Canada
Outcome results
None listed