IINB vs. QLB for Elective Open Inguinal Herniorrhaphy

Nerve Block Clinical Trial

Official title:

Ilioinguinal/Iliohypogastric vs. Quadratus Lumborum Nerve Blockade for Elective Open Inguinal Herniorrhaphy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007966
• Other study ID #: IRB00040354
• Status: Completed
• Phase: Phase 2
• Start date: January 30, 2017
• Est. completion date: February 17, 2018

Study information

• Verified date: October 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will be a double-blinded prospective randomized controlled equivalency trial comparing QLB to IINB. Patients presenting for unilateral open inguinal herniorrhaphy who agree to participate in the study and do not meet exclusion criteria will be randomized to either receiving an IINB or a QLB for post-operative analgesia. After performing a timeout, applying monitors (ECG, capnography, Sp02, non-invasive blood pressure), and confirming all paperwork per the usual pre-procedural check list the study participants will be administered procedural sedation (fentanyl and midazolam) to comfort as well as supplemental oxygen. The anatomy of both block sites will be identified by palpation of landmarks, labeling of structures with a skin marking pen, and visualization under ultrasound guidance. Both sites will be administered a small skin wheal of lidocaine 1% at the site the block needle would be introduced into the skin. Our intent with regards to administering a local anesthetic skin wheal is to increase our success in blinding the patient to which block was actually performed. A regional anesthetic block will only be performed at the randomized block site (IINB vs. QLB). After 15-30 minutes post block or post operatively the block will be assessed for success. Loss of cold sensation in the area of the surgical site would be indicative of block success. The patient will then proceed to the operating room and receive a general anesthetic with the final details of that anesthetic to be determined by the anesthesiologist responsible for the patient in the operating room. We will ask the operating room anesthesiologist and surgeon to avoid administration of medications that would confound our results. Specifically, no additional local anesthetic is to be injected at the incision site, no long acting opioids (hydromorphone, morphine, methadone etc…), dexamethasone or ketamine. After completion of the procedure the patient will recover in the post anesthesia care unit (PACU) where the participant will recover as per the usual process. The patient's discharge disposition will be at the discretion of the surgeon and anesthesiologist responsible for the participant's PACU care. The patient will be provided a diary that the participant will complete at 8hrs and 24hrs post block that will help the participant compile the data pertinent to the investigators primary and secondary outcomes. This diary should take no more than a minute or two for each sampling time. Participants will receive two phone calls at home to obtain this data at 8hrs and 24hrs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 17, 2018
• Est. primary completion date: February 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Herniorrhaphy
• Nerve Block
• Regional Anesthesia

Intervention

Procedure:
• Ilioinguinal / Iliohypogastric Block
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.
• Quadratus Lumborum Block
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.

Drug:
• Bupivacaine 0.25%
Administered as part of the local anesthetic mixture
• Epinephrine 1:200k
Administered as part of the local anesthetic mixture
• Clonidine 1.66mcg/cc
Administered as part of the local anesthetic mixture

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

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)

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-operative Verbal Pain Score at Rest	Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome	8 hrs Post Nerve Block
Secondary	Post-operative Verbal Pain Score at Rest	Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome	24 hrs Post Nerve Block
Secondary	Post-operative Verbal Pain Score With Activity	Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome	24hrs Post Nerve Block
Secondary	Time to First Oral Analgesic	When does the patient require their first post operative analgesic dose?	24hrs Post Nerve Block
Secondary	Time to Onset of Post Operative Pain	When does the patient first note post operative pain?	24hrs Post Nerve Block
Secondary	Total Opioid Consumption	Total opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent	24 hrs Post Nerve Block
Secondary	Number of Participants With Presence of Opioid Related Side Effects--Nausea		8 hrs Post Nerve Block
Secondary	Number of Participants With Presence of Opioid Related Side Effects--Itching		24 hrs Post Nerve Block
Secondary	Number of Participants With Presence of Opioid Related Side Effects--Itching		8 hrs Post Nerve Block
Secondary	Number of Participants With Presence of Opioid Related Side Effects--Vomiting		8 hrs Post Nerve Block
Secondary	Number of Participants With Presence of Opioid Related Side Effects--Nausea		24 hrs Post Nerve Block
Secondary	Number of Participants With Presence of Opioid Related Side Effects--Vomiting		24 hrs Post Nerve Block