Comparing Ilioinguinal Single-shot and Three-layer Blocks

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01625780
First received: April 12, 2012
Last updated: January 28, 2014
Last verified: June 2012
  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: 3-layer block
Procedure: Single-shot block

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

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: June 2015
Estimated Primary Completion Date: December 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: 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625780

Contacts
Contact: Ban Tsui, MD, MSc 780-407-8604 btsui@ualberta.ca

Locations
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         
Sponsors and Collaborators
University of Alberta
  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: January 28, 2014
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on August 26, 2014