IINB vs. QLB for Elective Open Inguinal Herniorrhaphy

NCT03007966 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00040354
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Open inguinal herniorrhaphy is a common outpatient surgical procedure. Post-operative pain can be a significant hindrance to discharge from the post anesthesia care unit. Pain can be treated with opioid therapy, but the literature supports that these agents are known to create or exacerbate adverse effects and complications, including post-operative nausea and vomiting, hypoxia, and urinary retention. In contrast, analgesia provided by regional anesthesia results in a decreased risk of the aforementioned complications.1 Because of this, various regional anesthetic techniques have been developed to provide analgesia following open herniorrhaphy. One technique is a combined ilioinguinal and iliohypogastric nerve block (IINB), which has been shown to decrease the initial pain after inguinal herniorrhaphy.2 The quadratus lumborum block (QLB) is a newer regional anesthetic technique that we think could be as effective as IINB at providing pain control following open herniorrhaphy. Additionally, because local anesthetic injected during a QLB has the potential to spread cranially into the thoracic paravertebral space following its lumbar deposition it could lead to alleviation of both somatic and visceral pain.3 This might therefore improve the quality and or duration of analgesia as compared to the IINB. To the best of the author's knowledge there has been no investigation comparing the efficacy, with regards to post-operative pain management, between IINB and QLB.

Conditions

Nerve Block; Herniorrhaphy; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Post-operative Verbal Pain Score With Movement

  Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome.

  8 hrs Post Nerve Block

Secondary Outcomes (12)

• Post-operative Verbal Pain Score at Rest

  8 hrs Post Nerve Block

• Post-operative Verbal Pain Score at Rest

  24 hrs Post Nerve Block

• Post-operative Verbal Pain Score With Activity

  24hrs Post Nerve Block

• Time to First Oral Analgesic

  24hrs Post Nerve Block

• Time to Onset of Post Operative Pain

  24hrs Post Nerve Block

Study Arms (2)

Ilioinguinal / Iliohypogastric Block

ACTIVE COMPARATOR

Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.

Procedure: Ilioinguinal / Iliohypogastric Block; Drug: Bupivacaine 0.25%; Drug: Epinephrine 1:200k; Drug: Clonidine 1.66mcg/cc

Quadratus Lumborum Block

EXPERIMENTAL

Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.

Procedure: Quadratus Lumborum Block; Drug: Bupivacaine 0.25%; Drug: Epinephrine 1:200k; Drug: Clonidine 1.66mcg/cc

Interventions

Ilioinguinal / Iliohypogastric Block PROCEDURE

Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.

Ilioinguinal / Iliohypogastric Block

Quadratus Lumborum Block PROCEDURE

Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.

Quadratus Lumborum Block

Bupivacaine 0.25% DRUG

Administered as part of the local anesthetic mixture

Ilioinguinal / Iliohypogastric Block; Quadratus Lumborum Block

Epinephrine 1:200k DRUG

Administered as part of the local anesthetic mixture

Ilioinguinal / Iliohypogastric Block; Quadratus Lumborum Block

Clonidine 1.66mcg/cc DRUG

Administered as part of the local anesthetic mixture

Ilioinguinal / Iliohypogastric Block; Quadratus Lumborum Block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patient's scheduled for elective unilateral open inguinal hernia repair at WFUBMC.

You may not qualify if:

• The anesthesiologist performing the intraoperative anesthetic deems the patient inappropriate for general anesthesia.
• If the patient uses more than 40mg of Oxycodone equivalents per 24 hours or is on extended release opioid formulations.
• If there is a contraindication to the performance of a regional block
• Concomitant anticoagulation use
• Allergy to local anesthetic
• Infectious or dermatologic conditions in the area of block placement that would otherwise increase the risk of peripheral nerve blockade
• Patient refusal
• Pregnancy
• Institutionalized individuals
• Extremes of age: Age \> 90 or \< 18
• Non English speaking

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (7)

• Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706. doi: 10.1097/00000542-200403000-00034.

  PMID: 15108988 BACKGROUND

• Toivonen J, Permi J, Rosenberg PH. Analgesia and discharge following preincisional ilioinguinal and iliohypogastric nerve block combined with general or spinal anaesthesia for inguinal herniorrhaphy. Acta Anaesthesiol Scand. 2004 Apr;48(4):480-5. doi: 10.1111/j.1399-6576.2004.00346.x.

  PMID: 15025612 BACKGROUND

• Børglum J, Jensen K, Moriggl B, et al. Ultrasound-Guided Transmuscular Quadratus Lumborum Blockade. BJA Out Blue E-Letters 2013. Available from http://bja.oxfordjournals. org/forum/topic/brjana_el%3B9919 (accessed 16 December 2015)

  BACKGROUND

• Farrar JT, Berlin JA, Strom BL. Clinically important changes in acute pain outcome measures: a validation study. J Pain Symptom Manage. 2003 May;25(5):406-11. doi: 10.1016/s0885-3924(03)00162-3.

  PMID: 12727037 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

• Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

  PMID: 3450848 BACKGROUND

• 7. Julious SA. Sample Sizes for Clinical Trials. Chapman and Hall/CRC, Boca Raton, FL, 2010.

  BACKGROUND

MeSH Terms

Interventions

Epinephrine; Clonidine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Christopher Edwards
• Organization: Wake Forest University Health Sciences

chedward@wakehealth.edu

336-716-4498

Study Officials

• Christopher J Edwards, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 2, 2017
• Study Start: January 30, 2017
• Primary Completion: February 17, 2018
• Study Completion: February 17, 2018
• Last Updated: November 18, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-10

Locations

US (1)