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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

February 28, 2011
April 23, 2013
April 2011
January 2013   (final data collection date for primary outcome measure)
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.
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 perncentage of patients recruited and randomized.
Complete list of historical versions of study NCT01307215 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 senory 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.
Not Provided
Not Provided
 
TAP Block: Does Volume Make a Difference?
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Post-operative Pain
  • Drug: Ropivacaine
    20mLs of 0.5%
    Other Names:
    • naropeine
    • naropin
  • Drug: Ropivacaine
    30mLs of 0.33%
    Other Names:
    • naropeine
    • naropin
  • Drug: Ropivacaine
    40mLs of 0.25%
    Other Names:
    • naropeine
    • naropin
  • Experimental: 20mLs of 0.5% ropivacaine per side
    Intervention: Drug: Ropivacaine
  • Experimental: 30mLs of 0.33% ropivacaine per side
    Intervention: Drug: Ropivacaine
  • Experimental: 40mLs of 0.25% ropivacaine per side
    Intervention: Drug: Ropivacaine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
March 2013
January 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01307215
10-3436
No
McMaster University
McMaster University
St. Joseph's Healthcare Hamilton
Principal Investigator: Mauricio Forero, MD McMaster University/St. Joseph's Healthcare
McMaster University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP