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NCT03007966 · ClinicalTrials.gov registry record · Phase 2
IINB vs. QLB for Elective Open Inguinal Herniorrhaphy
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT03007966 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 60 participants.
The verdict
NCT03007966, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study 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.
Interventions
- DRUG Bupivacaine 0.25%
- PROCEDURE Ilioinguinal / Iliohypogastric Block
- PROCEDURE Quadratus Lumborum Block
- DRUG Epinephrine 1:200k
- DRUG Clonidine 1.66mcg/cc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-01-30 |
| Est. Completion | 2018-02-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03007966
The ClinicalTrials.gov registry entry for NCT03007966 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Bupivacaine 0.25% is the first listed.
NCT03007966 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03007966 about?
NCT03007966 is a clinical study titled "IINB vs. QLB for Elective Open Inguinal Herniorrhaphy". 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 ...
What is the current status of trial NCT03007966?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2017-01-30. Estimated completion is 2018-02-17.
What interventions are being tested in trial NCT03007966?
The interventions under investigation include: Bupivacaine 0.25% (DRUG), Ilioinguinal / Iliohypogastric Block (PROCEDURE), Quadratus Lumborum Block (PROCEDURE), Epinephrine 1:200k (DRUG), Clonidine 1.66mcg/cc (DRUG).
Who is sponsoring clinical trial NCT03007966?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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