TAP Block for Gynaecological Laparotomies - a Comparison of Ultrasound-guided Block and Blind Technique

October 20, 2015 updated by: Dr. Pavel Michalek, Northern Health and Social Care Trust

Transversus Abdominis Plane (TAP) Block for Gynaecological Laparotomies - a Comparison of Ultrasound-guided Block and Blind Technique

Transversus abdominis plane (TAP) block is an application of local anaesthetic solution into the plane between internal oblique and transversus abdominis muscles at the triangle of Petit located superiorly to the iliac crests bilaterally. Anterior divisions of segmental spinal nerves, which provide innervation to the abdominal wall, run inside this compartment. TAP block been shown to provide good postoperative pain relief following surgical laparotomies, gynaecological laparotomies, appendicectomies, inguinal hernia repairs and open prostatectomies. The goal of this study is to compare the effect of blind and ultrasound-guided TAP block on postoperative pain relief and morphine consumption following to gynaecological laparotomies. Null research hypothesis for the study is that there is no difference between the performance (as defined by morphine consumption and patient satisfaction/ pain scores) of the TAP block procedure via 'blind' or ultrasound guided techniques for gynaecological laparotomies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transversus abdominis plane (TAP) block is an application of local anaesthetic solution into the plane between internal oblique and transversus abdominis muscles at the triangle of Petit located superiorly to the iliac crests bilaterally. Anterior divisions of segmental spinal nerves, which provide innervation to the abdominal wall, run inside this compartment. The TAP block has been shown to provide good postoperative pain relief following surgical laparotomies, gynaecological laparotomies, appendicectomies, inguinal hernia repairs and open prostatectomies. It also reduces the post operative morphine consumption seen after such procedures. This allows a more comfortable recovery with reduced incidence of nausea and vomiting, as well as potentially earlier mobilisation and discharge.

Currently the technique employed is that first described by Mc Donnell. This involves a blind 'two pop' technique signifying the needle passing through the two muscle layers. On detection of these two pops the local anaesthetic is injected into this plane between the muscle layers. It is the anaesthetising of the nerves in this muscle plane that aides post operative pain relief for as much as 24 hours. TAP nerve blocks have become common practice due to the very low reported complication rate occurring while using the 'blind technique'. Such complications are minor in themselves. It is our hope that these complications will be further reduced with the use of an ultrasound guided technique. The use of an ultrasound machine would allow the direct visualisation of the needles progress through the tissues and muscle layers. It would confirm the correct position during infiltration of local anaesthetic and prevent inadvertent puncturing of organs or entry to the abdominal space.

Studies have shown that in other commonly used nerve blocks, the introduction of an ultrasound guided technique has improved the efficacy of the nerve block itself. We hope to show a similar trend when using an ultrasound guided technique in the insertion of a TAP block. Trials are underway comparing different dosage and volume regimes, but to our knowledge no other trial is comparing the use of an ultrasound machine to the conventional 'blind' technique in order to assess pain relief and morphine consumption post operatively.

Only recently have ultrasound machines become commonplace in anaesthetic departments, and we feel this research will show their valuable contribution to patient comfort in this subgroup of patients undergoing abdominal gynaecological procedures. We wish to assess whether we can achieve better patient satisfaction, less morphine consumption and ultimately shorter hospital stay with an ultrasound technique compared to a blind technique.

Study Type

Interventional

Enrollment (Anticipated)

120

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 Locations

  • United Kingdom
    • Co. Antrim
      • Antrim, Co. Antrim, United Kingdom, BT41 2RL
        • Antrim Area Hospital

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

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients of ASA status I-III
  • Age 18-89 years
  • Gynaecological laparotomies with a need for extensive postoperative analgesia.

Exclusion Criteria:

  • Patient refusal
  • Age less than 18 years or more than 89 years
  • ASA status IV or V
  • Patients with known reaction to local anaesthetics

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Blind TAP block

TAP block technique as first described by McDonnell. Sterile field obtained with chlorhexidine wash and use of sterile gloves. Identification of triangle of Petit just above iliac crest and between external oblique and latissimus dorsi muscles. Insertion of regional anaesthesia needle perpendicular to skin, and its advancement until sensation of two 'pops' indicating advancement of needle through both external oblique and internal oblique muscle layers.

After confirmation of negative aspiration the local anaesthetic is injected slowly, (1mg/kg of levobupivacaine), concentration 2.5 mg/mL. Repeat procedure bilaterally (to a maximum dose of 2mg/kg of levobupivacaine).
Procedure: Transversus abdominis plane (TAP) block
Application of local anaesthetic solution (LA) levo-bupivacaine (dose 1mg/kg for each side, concentration 2.5 mg/mL) between internal oblique abdominis muscle and transversus abdominis muscle on both sides.
Other Names:
  • TAP block
Active Comparator: Ultrasound-guided TAP block

Technique as described by Hebbard. Sterile field obtained with chlorhexidine wash and use of sterile gloves. Ultrasound probe covered with sterile sheath.

Identification of triangle of Petit with USS probe perpendicular to skin. Insertion of regional anaesthesia needle transversely to the probe, using in-plane (IP) technique, moving posteriorly. Advancement of the needle under ultrasound control until its tip is located between internal oblique and transversus abdominis muscle layers.
Procedure: Transversus abdominis plane (TAP) block
Application of local anaesthetic solution (LA) levo-bupivacaine (dose 1mg/kg for each side, concentration 2.5 mg/mL) between internal oblique abdominis muscle and transversus abdominis muscle on both sides.
Other Names:
  • TAP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total consumption of morphine for PCA within the first 12, 24 and 48 hours
Time Frame: 12, 24, 48 hours
12, 24, 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of High Dependency Unit (recovery) stay
Time Frame: once at discharge
once at discharge
Length of hospital stay
Time Frame: Once at discharge
Once at discharge
Visual Analog Scale (VAS) reading
Time Frame: 30min after operation and then at 1hr, 2hrs, 4hrs, 6hrs, 12hrs, 24hrs, 48 hrs
30min after operation and then at 1hr, 2hrs, 4hrs, 6hrs, 12hrs, 24hrs, 48 hrs
Patient satisfaction
Time Frame: 12, 24 hrs
12, 24 hrs

Collaborators and Investigators

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

Sponsor

Northern Health and Social Care Trust

Investigators

  • Principal Investigator: Pavel Michalek, MD,PhD,DESA, Antrim Area Hospital, Northern HSC Trust

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, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

September 8, 2009

First Submitted That Met QC Criteria

September 8, 2009

First Posted (Estimate)

September 9, 2009

Study Record Updates

Last Update Posted (Estimate)

October 21, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09/NIR03/45

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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