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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by CES University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Gustavo Adolfo Calle Gomez, CES University
ClinicalTrials.gov Identifier:
NCT01596660
First received: April 30, 2012
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Block
Drug: Bupivacaina 0.5%
Drug: placebo comparator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Transversus Abdominis Bilateral Plane Block in Total Laparoscopic Hysterectomy : A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by CES University:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Saline solution

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596660

Contacts
Contact: Gustavo Adolfo Calle, Ginecólogo 5765700 gustavocalle.md@gmail.com
Contact: Claudia López, Ginecóloga 3104365060 cclopez04@yahoo.com

Locations
Colombia
Universidad CES Recruiting
Medellín, Antioquia, Colombia
Contact: Gustavo Calle, Ginecólogo    5765700    gcallemd@gmail.com   
Contact: Claudia López Ruiz, Ginecóloga    3104365060    cclopez04@yahoo.com   
Sponsors and Collaborators
CES University
Investigators
Study Director: Gustavo A Calle, MD CES University
  More Information

Publications:

Responsible Party: Gustavo Adolfo Calle Gomez, Principal investigator, CES University
ClinicalTrials.gov Identifier: NCT01596660     History of Changes
Other Study ID Numbers: 1-JMejia
Study First Received: April 30, 2012
Last Updated: May 9, 2012
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by CES University:
Tap block
laparoscopic hysterectomy
pain

Additional relevant MeSH terms:
Bupivacaine
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014