Clinical trial NCT01871181: US-guided Ilioinguinal Blocks Versus Local Infiltration
Official title: The Short and Long-term Effects of Ultrasound-guided Ilioinguinal and Iliohypogastric Nerve Block on Postoperative Pain Control Following Open Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Injection of local anesthetic drugs is an effective way to freeze (block) nerves to achieve loss of sensation during surgery and satisfactory pain control afterwards. Many studies have shown that nerve block is associated with higher degree of success in controlling pain after open inguinal hernia repair. Nerve block can be administered by a single injection with a long acting local anesthetic agent using ultrasound guidance. This study is to compare different techniques for freezing the nerves responsible for pain after open inguinal hernia repair. Patients will be randomized to one of two groups. In the first group, participants will receive ultrasound-guided nerve block following induction of general anesthesia but prior to surgical procedure. In the second group, participants will receive local anesthetic injection directly into the wound by the surgeon prior to closure. The investigators will assess the level of pain control for 48 hours after the surgical procedure. Patients will be provided with additional medications for pain relief if necessary. The investigators will also contact participants to follow-up with regard to possible chronic groin pain after 3 months following the surgical procedure.

Detailed description: populations. It is well-known that inguinal hernia surgery can lead to significant degree of acute perioperative pain. At the same time, patients undergoing inguinal hernia operation are at increased risk to develop chronic neuropathic groin pain. In the literature, several approaches to prophylaxis and treatment of perioperative pain have been described including: infiltration of local anesthetics by surgeons, ilioinguonal/iliohypogastric nerve blocks, neuroaxial blockade, and caudal block in pediatric petients.

Recent studies have shown that ultrasound guided ilioinguinal/iliohypogastric nerve block is associated with increased level of safety, improved success rate, and reduction in dose of local anesthetic required compared to the "blind" technique.

The aim of our study is to investigate the role of ultrasound guided ilioinguinal/iliohypogastric nerve block in prevention of perioperative and persistent neuropathic pain following open inguinal hernia repair in comparison with infiltration of local anesthetics by surgeons. In the first randomized group of patients we will perform ultrasound guided ilioinguinal/iliohypogastric nerve block using the same types and amount of local anesthetics. In the second group, patients will receive infiltration of the same type and amount of local anesthetics by surgeons.

Eligibility criteria: Inclusion Criteria:

* ASA 1-3
* Both gender
* 18 years and older
* Informed consent

Exclusion Criteria:

* ASA 4 and more
* Lack of informed consent
* Patients with history of chronic pain
* Patients on regular opioids
* History of allergic reaction to local anesthetics
* Medication or non-medication induced bleeding diastasis
* Infection at the site of injection
* Patients with bilateral hernias
* linguistic difficulties

Primary outcomes:
measure: Postoperative pain
timeFrame: 48 hours post-surgery
Secondary outcomes:
measure: Chronic pain
timeFrame: 6 months post-surgery
measure: Analgesic consumption
timeFrame: 48 hours post-surgery
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
References:
citation: Klaassen Z, Marshall E, Tubbs RS, Louis RG Jr, Wartmann CT, Loukas M. Anatomy of the ilioinguinal and iliohypogastric nerves with observations of their spinal nerve contributions. Clin Anat. 2011 May;24(4):454-61. doi: 10.1002/ca.21098. Epub 2011 Jan 3.
citation: Ndiaye A, Diop M, Ndoye JM, Ndiaye A, Mane L, Nazarian S, Dia A. Emergence and distribution of the ilioinguinal nerve in the inguinal region: applications to the ilioinguinal anaesthetic block (about 100 dissections). Surg Radiol Anat. 2010 Jan;32(1):55-62. doi: 10.1007/s00276-009-0549-0. Epub 2009 Aug 26.
citation: Andersen FH, Nielsen K, Kehlet H. Combined ilioinguinal blockade and local infiltration anaesthesia for groin hernia repair--a double-blind randomized study. Br J Anaesth. 2005 Apr;94(4):520-3. doi: 10.1093/bja/aei083. Epub 2005 Feb 4.
citation: Jagannathan N, Sohn L, Sawardekar A, Ambrosy A, Hagerty J, Chin A, Barsness K, Suresh S. Unilateral groin surgery in children: will the addition of an ultrasound-guided ilioinguinal nerve block enhance the duration of analgesia of a single-shot caudal block? Paediatr Anaesth. 2009 Sep;19(9):892-8. doi: 10.1111/j.1460-9592.2009.03092.x. Epub 2009 Jul 13.
citation: Suresh S, Patel A, Porfyris S, Ryee MY. Ultrasound-guided serial ilioinguinal nerve blocks for management of chronic groin pain secondary to ilioinguinal neuralgia in adolescents. Paediatr Anaesth. 2008 Aug;18(8):775-8. doi: 10.1111/j.1460-9592.2008.02596.x.
citation: Wang H. Is ilioinguinal-iliohypogastric nerve block an underused anesthetic technique for inguinal herniorrhaphy? South Med J. 2006 Jan;99(1):15. doi: 10.1097/01.smj.0000197300.37083.a8. No abstract available.
citation: Wehbe SA, Ghulmiyyah LM, Dominique el-KH, Hosford SL, Ehleben CM, Saltzman SL, Sills ES. Prospective randomized trial of iliohypogastric-ilioinguinal nerve block on post-operative morphine use after inpatient surgery of the female reproductive tract. J Negat Results Biomed. 2008 Nov 28;7:11. doi: 10.1186/1477-5751-7-11.