Local Anesthesia Clinical Trial
Official title:
A New Approach to Ilio-inguinal Nerve Blocks: 3-layer Injection vs Conventional Ultrasound-guided Single-shot Approach
NCT number | NCT01625780 |
Other study ID # | Pro00027444 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2012 |
Est. completion date | March 2017 |
Verified date | October 2016 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 32 |
Est. completion date | March 2017 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 16 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Stollery Children's Hospital | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Dalens B, Ecoffey C, Joly A, Giaufré E, Gustafsson U, Huledal G, Larsson LE. Pharmacokinetics and analgesic effect of ropivacaine following ilioinguinal/iliohypogastric nerve block in children. Paediatr Anaesth. 2001 Jul;11(4):415-20. — View Citation
Langer JC, Shandling B, Rosenberg M. Intraoperative bupivacaine during outpatient hernia repair in children: a randomized double blind trial. J Pediatr Surg. 1987 Mar;22(3):267-70. — View Citation
Lim SL, Ng Sb A, Tan GM. Ilioinguinal and iliohypogastric nerve block revisited: single shot versus double shot technique for hernia repair in children. Paediatr Anaesth. 2002 Mar;12(3):255-60. — View Citation
Splinter WM, Bass J, Komocar L. Regional anaesthesia for hernia repair in children: local vs caudal anaesthesia. Can J Anaesth. 1995 Mar;42(3):197-200. — View Citation
Walker S, Orlikowski C. A randomised study of ilio-inguinal nerve blocks following inguinal hernia repair: a stopped randomised controlled trial. Int J Surg. 2008 Feb;6(1):23-7. Epub 2007 Oct 24. — View Citation
Willschke H, Bösenberg A, Marhofer P, Johnston S, Kettner S, Eichenberger U, Wanzel O, Kapral S. Ultrasonographic-guided ilioinguinal/iliohypogastric nerve block in pediatric anesthesia: what is the optimal volume? Anesth Analg. 2006 Jun;102(6):1680-4. — View Citation
Willschke H, Marhofer P, Bösenberg A, Johnston S, Wanzel O, Cox SG, Sitzwohl C, Kapral S. Ultrasonography for ilioinguinal/iliohypogastric nerve blocks in children. Br J Anaesth. 2005 Aug;95(2):226-30. Epub 2005 May 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to completion of block for equal analgesia (intraoperative or post-operative need for rescue analgesia) | Time (in seconds/minutes) taken to achieve a satisfactory ilioinguinal nerve block will be recorded. | From identification of needle insertion site to end of injection of local anesthetic (single shot blocks are typically completed within 5 minutes) | |
Secondary | Time to onset of block | Time taken to achieve effective nerve block will be recorded. | When maximal nerve block is achieved (after approximately 20 minutes for single-shot blocks) | |
Secondary | Change in heart rate upon surgical incision | Patient heart rate will be recorded at the moment the surgical incision is made. | At the moment the skin incision is made (varies; intra-operative) |
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