Comparing Ilioinguinal Single-shot and Three-layer Blocks
|ClinicalTrials.gov Identifier: NCT01625780|
Recruitment Status : Terminated (Not a significant difference in outcomes between groups)
First Posted : June 21, 2012
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ilioinguinal Nerve Block Local Anesthesia Post-operative Analgesia||Procedure: 3-layer block Procedure: Single-shot block||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A New Approach to Ilio-inguinal Nerve Blocks: 3-layer Injection vs Conventional Ultrasound-guided Single-shot Approach|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||March 2017|
Experimental: Study group: 3-layer block
Patients in this group will receive the 3-layer ilioinguinal nerve block.
Procedure: 3-layer block
0.3 mL/kg of 0.25% bupivacaine (one injection in each layer) will be delivered by the "3-layer" method using a standard 20-gauge block needle.
Active Comparator: Control: single-shot block
Patients in this group will receive a standard, single-shot ilioinguinal nerve block.
Procedure: Single-shot block
0.3 mL/kg of 0.25% bupivacaine will be delivered by the standard, single-shot method using a 20-gauge block needle.
- Time to completion of block for equal analgesia (intraoperative or post-operative need for rescue analgesia) [ Time Frame: From identification of needle insertion site to end of injection of local anesthetic (single shot blocks are typically completed within 5 minutes) ]Time (in seconds/minutes) taken to achieve a satisfactory ilioinguinal nerve block will be recorded.
- Time to onset of block [ Time Frame: When maximal nerve block is achieved (after approximately 20 minutes for single-shot blocks) ]Time taken to achieve effective nerve block will be recorded.
- Change in heart rate upon surgical incision [ Time Frame: At the moment the skin incision is made (varies; intra-operative) ]Patient heart rate will be recorded at the moment the surgical incision is made.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625780
|Stollery Children's Hospital|
|Edmonton, Alberta, Canada, T6G 2C8|