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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

Tracking Information
First Submitted Date  ICMJE December 22, 2016
First Posted Date  ICMJE January 2, 2017
Last Update Posted Date July 16, 2018
Actual Study Start Date  ICMJE January 30, 2017
Actual Primary Completion Date February 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2016)
Post-operative verbal pain score with movement [ Time Frame: 8 hrs ]
Assessed on an 11-point (0-10) numeric analog scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03007966 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2016)
  • Post-operative verbal pain score at rest [ Time Frame: 8 hrs ]
    Assessed on an 11-point (0-10) numeric analog scale
  • Post-operative verbal pain score at rest [ Time Frame: 24 hrs ]
    Assessed on an 11 point (0-10) numeric analog scale
  • Post-operative verbal pain score with activity [ Time Frame: 24hrs ]
    Assessed on an 11 point (0-10) numeric analog scale
  • Time to first oral analgesic [ Time Frame: 24hrs ]
    When does the patient require their first post operative analgesic dose?
  • Time to onset of post operative pain [ Time Frame: 24hrs ]
    When does the patient first note post operative pain?
  • Total opioid consumption [ Time Frame: 24 hrs ]
    Total opioids consumed during the first 24hrs post operatively.
  • Presence of opioid related side effects [ Time Frame: 8 hrs ]
    Presence of opioid related side effects (Nausea, Vomiting, and Itching)
  • Presence of opioid related side effects [ Time Frame: 24 hrs ]
    Presence of opioid related side effects (Nausea, Vomiting, and Itching)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IINB vs. QLB for Elective Open Inguinal Herniorrhaphy
Official Title  ICMJE Ilioinguinal/Iliohypogastric vs. Quadratus Lumborum Nerve Blockade for Elective Open Inguinal Herniorrhaphy
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Nerve Block
  • Herniorrhaphy
  • Regional Anesthesia
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Ilioinguinal / Iliohypogastric Block
    • Drug: Bupivacaine 0.25%
    • Drug: Epinephrine 1:200k
    • Drug: Clonidine 1.66mcg/cc
  • 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.
    Interventions:
    • Procedure: Quadratus Lumborum Block
    • Drug: Bupivacaine 0.25%
    • Drug: Epinephrine 1:200k
    • Drug: Clonidine 1.66mcg/cc
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 17, 2018
Actual Primary Completion Date February 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03007966
Other Study ID Numbers  ICMJE IRB00040354
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher J Edwards, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP