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TAP Block: Does Volume Make a Difference?

This study has been completed.
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01307215
First received: February 28, 2011
Last updated: April 23, 2013
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Post-operative Pain
 Drug: Ropivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Lumbar Transversus Abdominal Plane (TAP) Block: Does Volume Make a Difference?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • To assess the feasibility of a large scale clinical study to determine the influence on increasing the local anesthetic volume. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    This will be shown as a number and a percenttage of patients recruited and randomized.


Secondary Outcome Measures:
  • Using ice and pinprick, determine the dermatomal block distribution at 2,6,12,24 and 48 hours post block. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    The assessor will measure the extend of the block distribution at the various time intervals.

  • Pain scores at 2,6,12,24, and 48 hours post-block. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Using a visual analog scale, patient pain scores will be assessed.

  • Patient-controlled analgesia opioid requirements at 2,6,12,24 and 48 post-block. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Record drug consumption at the time intervals

  • Incidence of post-operative nausea and vomiting at 2,6,12,24, and 48 hours. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Block failure rate. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Block failure rate is defined as the lack of any sensory block following the TAP block.

  • Patient's overall satisfaction. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Using a LIKERT score, patient satisfaction will be measured.

  • Discharge time from PACU. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The time in which the patient is discharged from the recovery room.


Enrollment: 31
Study Start Date: April 2011
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 20mLs of 0.5% ropivacaine per side Drug: Ropivacaine
20mLs of 0.5%
Other Names:
  • naropeine
  • naropin
Experimental: 30mLs of 0.33% ropivacaine per side Drug: Ropivacaine
30mLs of 0.33%
Other Names:
  • naropeine
  • naropin
Experimental: 40mLs of 0.25% ropivacaine per side Drug: Ropivacaine
40mLs of 0.25%
Other Names:
  • naropeine
  • naropin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307215

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
McMaster University
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Mauricio Forero, MD McMaster University/St. Joseph's Healthcare
  More Information

Publications:

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01307215     History of Changes
Other Study ID Numbers: 10-3436
Study First Received: February 28, 2011
Last Updated: April 23, 2013
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by McMaster University:
TAP block
incision pain
total hysterectomy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
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 June 18, 2013