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Transversus Abdominis Bilateral Plane Block in Total Laparoscopic Hysterectomy : A Randomized Controlled Trial

NCT01596660 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-05-11

No results posted yet for this study

Summary

The ambulatory management after laparoscopic hysterectomy is a reality in our service, where 90% of hysterectomies are laparoscopically done and 80% of these are managed on an ambulatory basis with shorter hospital stay ;less than 12 hours. (OALOS 9.41 + / - (1.79) range from 5 to 12 hours and POLE 5.38 + / - (1.8) range from 2 to 9 hours)

So far the immediate analgesic management has been made systemically, and the satisfaction reported by patients was high, even though some patients require longer stay in recovery and need higher doses of analgesics before their discharge criteria, allowing an optimal ambulatory management.

There are several treatment options that theoretically could be used but the results have been variable and have failed to demonstrate the expected benefit.

The Transversus Abdominis Plane Block consists in the deposition of local anesthetic in the plane between the internal oblique and transverse abdominal, looking to infiltrate the spinal nerves at this level, so the innervation to the skin, muscles and the parietal peritoneum will be interrupted. The TAP Block was first described in 2001 , based on anatomy marks techniques of the peripheral nerves and was developed and evaluated later by McDonnell et al.

Conditions

  • Block

Interventions

DRUG

Bupivacaina 0.5%

Bupivacaina 0.5% 20cc

DRUG

placebo comparator

20 cc of saline solution 0.9%, to infiltrate each side.

Sponsors & Collaborators

  • CES University

    lead OTHER

Principal Investigators

  • Gustavo A Calle, MD · CES University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01596660 on ClinicalTrials.gov