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

May 9, 2012 updated by: Gustavo Adolfo Calle Gomez, CES University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The blockage in the abdominal transverse plane (TAP Block) with local anesthetic has demonstrated efficacy and safety in patients with various types of abdominal surgery by laparotomy as both laparoscopically.

The blockage in the abdominal transverse plane is a single entry in the triangle of Petit, to access a greater number of nerves that allow a wider spread of analgesia. The innervation of the anterolateral abdominal wall is given by the anterior branches of spinal nerves T7 to L1 (these include the intercostal nerves T7 at 11, the nerve subcostal nerve T12 and ilio hypogastric and ilio inguinal L1

The anterior divisions of the nerves T7 to T11 continues from the intercostal space and enter the abdominal wall between the internal oblique and transversus abdominis, reaching the rectus abdominis, which pierce and innervate the skin of the anterior abdominal region. In its course also innervate the external oblique muscle via the lateral cutaneous branch is divided into anterior and posterior innervating the external oblique and dorsal latium

The anterior branch of T12 is connected to the ilio hypogastric nerve and gives branch to the piriformis muscle, the lateral cutaneous branch pierces the internal and external oblique muscles and descends over the iliac crest innervate the anterior part of the buttocks.

The ilio hypogastric nerve,L1, is divided between the internal oblique and transversus abdominis near the iliac crest in two anterior and lateral cutaneous branches, the first innervate the skin of the buttocks and the second the hypogastric region.

The ilio inguinal nerve communicates with the ilio hypogastric nerve between the internal oblique and transversus abdominis, near the anterior iliac crest and innervates the anterior and medial thigh and part of the skin covering the genitals.

The aim of the nerve block is to deposit local anesthetic in the plane between the internal oblique and transverse abdominal looking to infiltrate the spinal nerves at this level, so the skin innervation on muscle and parietal peritoneum will interrupted. Obviously if the surgery goes through the peritoneal cavity, visceral pain will not be interrupted.

This block is indicated in any lower abdominal surgery and has been used effectively in laparoscopic surgery, so far no work described in LH, this block allows analgesia from T7 to L1 even with minimal side effects, low cost, without altering surgical time, and low risk. Among the complications described above, a puncture of the liver in a patient with liver elongated and some small punctures without serious consequences.

The ambulatory management could be more efficient with the use of blockage in the abdominal transverse plane (TAP Block) with local anesthetic. In order to study the benefits that the TAP Block could offer to our patients, we suggest a randomized controlled trial comparing the blockage in the abdominal transverse plane with placebo.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia
        • Recruiting
        • Universidad CES
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All patients scheduled for laparoscopic hysterectomy for benign causes.
  • ASA 1 and 2
  • Patients without contraindications to the administration of local anesthetics
  • Patients without contraindications to NSAIDs or acetaminophen.
  • Patients with no simultaneous intervention (only laparoscopic hysterectomy)
  • Patients living in the metropolitan area, with telephone line, can be contacted by telephone in the first 72 hours by calling 24, 48 and 72 hours, conducted by researchers at the number previously reported by the patient.
  • An adequate level of understanding, ie patients who are able to communicate by telephone and understand a numerical scale.
  • Who agree to participate in the work.

Exclusion Criteria:

  • Patients who should undergo a change in the standard anesthetic technique.
  • Patients who are hospitalized after total laparoscopic hysterectomy.
  • Patients with a body mass index above 30.
  • Laparoscopic hysterectomy with a longer duration to 120 minutes.
  • Patients who do not they can be reached by phone at pre-set times.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bupivacaina
20 cc of bupivacaine 0.5% in 20 cc de saline solution and it is infiltrated 20 cc each side.
Drug: Bupivacaina 0.5%
Bupivacaina 0.5% 20cc
Other Names:
  • Bupivacaine
Placebo Comparator: saline solution
20 cc of saline solution 0.9% to infiltrate each side.
Drug: placebo comparator
20 cc of saline solution 0.9%, to infiltrate each side.
Other Names:
  • Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 24 hours
The instrument used to assess pain intensity is a straight line marked with numbers 1 to 10, with 1 meaning absence of pain and 10 the worst pain imaginable. The patient marks a point on the line that matches the pain she feels.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CES University

Investigators

  • Study Director: Gustavo A Calle, MD, CES University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 11, 2012

Study Record Updates

Last Update Posted (Estimate)

May 11, 2012

Last Update Submitted That Met QC Criteria

May 9, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-JMejia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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