TAP Block: Does Volume Make a Difference?

April 23, 2013 updated by: McMaster University

Lumbar Transversus Abdominal Plane (TAP) Block: Does Volume Make a Difference?

Patients who have abdominal surgery will experience pain from the incision. The lumbar TAP block is a procedure used to reach the nerve endings in the abdominal wall so that there is a reduction in pain after surgery. Using ultrasound guidance, a solution of ropivacaine will be injected after surgery. The aim of this study is to determine the effect of changes in the volume of the injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pain from a surgical incision happens in most patients. During the perioperative period, the use of the TAP block has been shown to reduce pain scores, opioid consumption and sedation scores. Also, there is a trend towards a reduction of post-operative nausea and vomiting. The aim of the block is to reach the distal nerve endings of the abdominal wall from T6 to L1 dermatomes using ultrasound guidance with a single shot of ropivacaine at different volumes. Currently, there is consensus about optimal procedure-specific volumes and local anesthetic concentrations for lumbar TAP blocks. This is a pilot study and the purpose being is it feasible to do a large scale clinical study to determine the influence of increasing the local anesthetic volume.

Study Type

Interventional

Enrollment (Actual)

31

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

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18-70 years old
  • total abdominal hysterectomy
  • capable of completing informed consent
  • no previous chronic opioid use
  • no previous abdominal wall surgeries

Exclusion Criteria:

  • patient refusal
  • contraindication to regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders,
  • local or systemic infection
  • local anesthetic allergy
  • BMI>35

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 20mLs of 0.5% ropivacaine per side
Drug: Ropivacaine
20mLs of 0.5%
Other Names:
  • naropin
  • naropeine
Drug: Ropivacaine
30mLs of 0.33%
Other Names:
  • naropin
  • naropeine
Drug: Ropivacaine
40mLs of 0.25%
Other Names:
  • naropin
  • naropeine
Experimental: 30mLs of 0.33% ropivacaine per side
Drug: Ropivacaine
20mLs of 0.5%
Other Names:
  • naropin
  • naropeine
Drug: Ropivacaine
30mLs of 0.33%
Other Names:
  • naropin
  • naropeine
Drug: Ropivacaine
40mLs of 0.25%
Other Names:
  • naropin
  • naropeine
Experimental: 40mLs of 0.25% ropivacaine per side
Drug: Ropivacaine
20mLs of 0.5%
Other Names:
  • naropin
  • naropeine
Drug: Ropivacaine
30mLs of 0.33%
Other Names:
  • naropin
  • naropeine
Drug: Ropivacaine
40mLs of 0.25%
Other Names:
  • naropin
  • naropeine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the feasibility of a large scale clinical study to determine the influence on increasing the local anesthetic volume.
Time Frame: 6 month
This will be shown as a number and a percenttage of patients recruited and randomized.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Using ice and pinprick, determine the dermatomal block distribution at 2,6,12,24 and 48 hours post block.
Time Frame: 48 hours
The assessor will measure the extend of the block distribution at the various time intervals.
48 hours
Pain scores at 2,6,12,24, and 48 hours post-block.
Time Frame: 48 hours
Using a visual analog scale, patient pain scores will be assessed.
48 hours
Patient-controlled analgesia opioid requirements at 2,6,12,24 and 48 post-block.
Time Frame: 48 hours
Record drug consumption at the time intervals
48 hours
Incidence of post-operative nausea and vomiting at 2,6,12,24, and 48 hours.
Time Frame: 48 hours
48 hours
Block failure rate.
Time Frame: 48 hours
Block failure rate is defined as the lack of any sensory block following the TAP block.
48 hours
Patient's overall satisfaction.
Time Frame: 48 hours
Using a LIKERT score, patient satisfaction will be measured.
48 hours
Discharge time from PACU.
Time Frame: 24 hours
The time in which the patient is discharged from the recovery room.
24 hours

Collaborators and Investigators

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

Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

Investigators

  • Principal Investigator: Mauricio Forero, MD, McMaster University/St. Joseph's Healthcare

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

April 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

February 28, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (Estimate)

March 2, 2011

Study Record Updates

Last Update Posted (Estimate)

April 24, 2013

Last Update Submitted That Met QC Criteria

April 23, 2013

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-3436

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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