IINB vs. QLB for Elective Open Inguinal Herniorrhaphy

NCT03007966 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-11-18

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Christopher J Edwards, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2018-02-17
Completion
2018-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03007966 on ClinicalTrials.gov