TAP Block: Does Volume Make a Difference?
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|ClinicalTrials.gov Identifier: NCT01307215|
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : April 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Post-operative Pain||Drug: Ropivacaine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Lumbar Transversus Abdominal Plane (TAP) Block: Does Volume Make a Difference?|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||March 2013|
|Experimental: 20mLs of 0.5% ropivacaine per side||
20mLs of 0.5%
|Experimental: 30mLs of 0.33% ropivacaine per side||
30mLs of 0.33%
|Experimental: 40mLs of 0.25% ropivacaine per side||
40mLs of 0.25%
- 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.
- 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.
- 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.
- 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
- Incidence of post-operative nausea and vomiting at 2,6,12,24, and 48 hours. [ Time Frame: 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.
- Patient's overall satisfaction. [ Time Frame: 48 hours ]Using a LIKERT score, patient satisfaction will be measured.
- Discharge time from PACU. [ Time Frame: 24 hours ]The time in which the patient is discharged from the recovery room.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307215
|St. Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Mauricio Forero, MD||McMaster University/St. Joseph's Healthcare|