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IINB vs. QLB for Elective Open Inguinal Herniorrhaphy

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ClinicalTrials.gov Identifier: NCT03007966
Recruitment Status : Completed
First Posted : January 2, 2017
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Nerve Block Herniorrhaphy Regional Anesthesia Procedure: Ilioinguinal / Iliohypogastric Block Procedure: Quadratus Lumborum Block Drug: Bupivacaine 0.25% Drug: Epinephrine 1:200k Drug: Clonidine 1.66mcg/cc Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ilioinguinal/Iliohypogastric vs. Quadratus Lumborum Nerve Blockade for Elective Open Inguinal Herniorrhaphy
Actual Study Start Date : January 30, 2017
Actual Primary Completion Date : February 17, 2018
Actual Study Completion Date : February 17, 2018

Arm Intervention/treatment
Active Comparator: Ilioinguinal / Iliohypogastric Block
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
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.

Drug: Bupivacaine 0.25%
Administered as part of the local anesthetic mixture

Drug: Epinephrine 1:200k
Administered as part of the local anesthetic mixture

Drug: Clonidine 1.66mcg/cc
Administered as part of the local anesthetic mixture

Experimental: Quadratus Lumborum Block
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
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

Drug: Epinephrine 1:200k
Administered as part of the local anesthetic mixture

Drug: Clonidine 1.66mcg/cc
Administered as part of the local anesthetic mixture




Primary Outcome Measures :
  1. Post-operative verbal pain score with movement [ Time Frame: 8 hrs ]
    Assessed on an 11-point (0-10) numeric analog scale


Secondary Outcome Measures :
  1. Post-operative verbal pain score at rest [ Time Frame: 8 hrs ]
    Assessed on an 11-point (0-10) numeric analog scale

  2. Post-operative verbal pain score at rest [ Time Frame: 24 hrs ]
    Assessed on an 11 point (0-10) numeric analog scale

  3. Post-operative verbal pain score with activity [ Time Frame: 24hrs ]
    Assessed on an 11 point (0-10) numeric analog scale

  4. Time to first oral analgesic [ Time Frame: 24hrs ]
    When does the patient require their first post operative analgesic dose?

  5. Time to onset of post operative pain [ Time Frame: 24hrs ]
    When does the patient first note post operative pain?

  6. Total opioid consumption [ Time Frame: 24 hrs ]
    Total opioids consumed during the first 24hrs post operatively.

  7. Presence of opioid related side effects [ Time Frame: 8 hrs ]
    Presence of opioid related side effects (Nausea, Vomiting, and Itching)

  8. Presence of opioid related side effects [ Time Frame: 24 hrs ]
    Presence of opioid related side effects (Nausea, Vomiting, and Itching)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007966


Locations
United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Christopher J Edwards, MD Wake Forest University Health Sciences

Publications:
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03007966     History of Changes
Other Study ID Numbers: IRB00040354
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Epinephrine
Racepinephrine
Epinephryl borate
Clonidine
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Analgesics
Antihypertensive Agents
Sympatholytics
Adrenergic alpha-2 Receptor Agonists