Comparing Ilioinguinal Single-shot and Three-layer Blocks

NCT01625780 | Terminated

• 1 other identifier: Pro00027444
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Ilioinguinal Nerve Block; Local Anesthesia; Post-operative Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to onset of block

  When maximal nerve block is achieved (after approximately 20 minutes for single-shot blocks)

• Change in heart rate upon surgical incision

  At the moment the skin incision is made (varies; intra-operative)

Study Arms (2)

Study group: 3-layer block

EXPERIMENTAL

Patients in this group will receive the 3-layer ilioinguinal nerve block.

Procedure: 3-layer block

Control: single-shot block

ACTIVE COMPARATOR

Patients in this group will receive a standard, single-shot ilioinguinal nerve block.

Procedure: Single-shot block

Interventions

3-layer block PROCEDURE

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.

Study group: 3-layer block

Single-shot block PROCEDURE

0.3 mL/kg of 0.25% bupivacaine will be delivered by the standard, single-shot method using a 20-gauge block needle.

Control: single-shot block

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA I-II children aged 0-16 presenting for inguinal surgery (inguinal hernia, hydrocele repair, or orchidopexy)

You may not qualify if:

• Patient or parent refusal to participate in study, local anesthetic allergy, or any other contraindication to ilio-inguinal nerve block.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2C8, Canada

Location

Related Publications (7)

• 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. doi: 10.1016/s0022-3468(87)80344-5.

  PMID: 3550031 BACKGROUND

• 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. doi: 10.1007/BF03010675.

  PMID: 7743568 BACKGROUND

• Dalens B, Ecoffey C, Joly A, Giaufre 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. doi: 10.1046/j.1460-9592.2001.00691.x.

  PMID: 11442857 BACKGROUND

• Willschke H, Bosenberg 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. doi: 10.1213/01.ane.0000217196.34354.5a.

  PMID: 16717308 BACKGROUND

• 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. doi: 10.1046/j.1460-9592.2002.00832.x.

  PMID: 11903940 BACKGROUND

• 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. doi: 10.1016/j.ijsu.2007.10.003. Epub 2007 Oct 24.

  PMID: 18053781 BACKGROUND

• Willschke H, Marhofer P, Bosenberg 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. doi: 10.1093/bja/aei157. Epub 2005 May 27.

  PMID: 15923270 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: June 21, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: March 1, 2017
• Last Updated: March 24, 2020

Record last verified: 2016-10

Locations

CA (1)