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 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?|
- 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.
- 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.
|Study Start Date:||April 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|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%
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307215
|St. Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Mauricio Forero, MD||McMaster University/St. Joseph's Healthcare|