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Comparing Ilioinguinal Single-shot and Three-layer Blocks

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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
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
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 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
Allocation: Randomized
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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): NCT01625780


Locations
Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2C8
Sponsors and Collaborators
University of Alberta

Publications:
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01625780     History of Changes
Other Study ID Numbers: Pro00027444
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016