Comparing Ilioinguinal Single-shot and Three-layer Blocks
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Purpose
Ilio-inguinal nerve blocks have a long history of efficacy in treatment of post-operative pain following inguinal surgery. Several anatomic studies have shown that the nerves supplying the inguinal area have a certain degree of variability with respect to their location between the internal and external oblique layers of the anterior abdominal wall. Furthermore, the standard single-shot approach to ilio-inguinal nerve blocks has a significant incidence of unintended femoral nerve block, which can impair patients' ability to walk after surgery. The investigators are proposing a new approach to the ilio-inguinal nerve block, which divides the total dose of local anesthetic into 3 equal parts, injecting each 1/3 into different layers of the anterior abdominal wall and sub-cutaneously. The investigators intend to show that this new technique, the Tsui approach, provides equal analgesia to the standard single-shot ultrasound-guided ilio-inguinal nerve block, while being faster to perform and having a lower incidence of unintended femoral nerve blockade. Patients under age 10 who are scheduled for elective inguinal surgery (hydrocele repair, orchidopexy, and inguinal hernia repair), who have already consented to an ilio-inguinal nerve block that is commonly placed for this type of procedure, will be approached to participate in this study. No increased risk is anticipated for these patients, as both ultrasound-guided and blind techniques are equally well-accepted in the literature for this type of block, and in addition there are few vascular or neural structures in this anatomical area (just medial and inferior to the anterior superior iliac spine) that may be damaged. Follow-up will be limited to an assessment of pain scores in the PACU post-operatively and any unintended femoral nerve blockade in post-PACU. This will not delay their hospital discharge as these are same-day surgery patients.
| Condition | Intervention |
|---|---|
|
Ilioinguinal Nerve Block Local Anesthesia Post-operative Analgesia |
Procedure: Local anesthetic injection |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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 |
- 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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]Patient heart rate will be recorded at the moment the surgical incision is made.
| Estimated Enrollment: | 64 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Study group: 3-layer block
Patients in this group will receive the 3-layer ilioinguinal nerve block.
|
Procedure: Local anesthetic injection
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: Local anesthetic injection
0.3 mL/kg of 0.25% bupivacaine will be delivered by the standard, single-shot method using a 20-gauge block needle.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ASA I-II children aged 0-16 presenting for inguinal surgery (inguinal hernia, hydrocele repair, or orchidopexy)
Exclusion Criteria:
- Patient or parent refusal to participate in study, local anesthetic allergy, or any other contraindication to ilio-inguinal nerve block.
Contacts and Locations| Contact: Ban Tsui, MD, MSc | 780-407-8604 | btsui@ualberta.ca |
| Canada, Alberta | |
| Stollery Children's Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G 2C8 | |
| Principal Investigator: Ban Tsui, MD, MSc | |
| Sub-Investigator: Ariane Fielding, MD | |
| Sub-Investigator: Gareth Corry, PhD | |
More Information
Publications:
| Responsible Party: | University of Alberta |
| ClinicalTrials.gov Identifier: | NCT01625780 History of Changes |
| Other Study ID Numbers: | Pro00027444 |
| Study First Received: | April 12, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
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 May 22, 2013