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NCT03541941 · ClinicalTrials.gov registry record · Phase 4
Exparel vs. Bupivacaine Hydrochloride vs. Placebo for Hernia Repair
A Phase 4 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 164
- Enrollment target
NCT03541941 is a Phase 4 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 164 participants.
The verdict
NCT03541941, a Phase 4 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 164 participants
- Enrollment target
Study Summary
Patients usually experience some level of pain after their hernia repair. To control pain after the operation, surgeons have many options. One of them is to make some injections of pain blocker medications into the nerves that are responsible for the sensations the abdominal wall.This procedure is called TAP block (transversus abdominis place block). These medications are called local anesthetics, and there is a variety of medications that can be used. One of such medications is called Exparel® (Liposomal Bupivacaine). Exparel® has the potential benefit of lasting more hours than regular anesthetics. Although this drug is being used with increasing frequency, the investigators do not have good quality studies investigating the benefits of using this medication during a hernia repair, especially when compared to other types of local anesthetics (Bupivacaine Hydrochloride) or when compared to not injecting this medication at all. This study aim to investigate if Exparel®, when injected in the nerves of the abdominal wall during hernia repair can: (1) reduce the dose of additional opioid medications (morphine and similar) needed to achieve good pain control and (2) result in lower pain scores. The hypothesis is that Exparel® will result in a 30% decrease in the total requirements for opioid medications during the first 72 hours after surgery. Patients will be randomized to receive either Exparel®+Bupivacaine Hydrochloride, Bupivacaine Hydrochloride or Placebo (normal saline) during the operation through a TAP block. All patients will receive a patient controlled analgesia device after the operation, where patients can simply push a button every time they feel pain and the device will administer a dose of opioid medications. The investigators of the study will record the necessary amount of opioids used by the patients to achieve good pain control and also record pain scores several times during hospital stay.
Interventions
- DRUG Placebo
- DRUG Exparel
- DRUG Bupivacaine Hcl 0.25% Inj
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2018-07-03 |
| Est. Completion | 2019-12-19 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03541941
The ClinicalTrials.gov registry entry for NCT03541941 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03541941 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03541941 about?
NCT03541941 is a clinical study titled "Exparel vs. Bupivacaine Hydrochloride vs. Placebo for Hernia Repair". Patients usually experience some level of pain after their hernia repair. To control pain after the operation, surgeons have many options. One of them is to make some injections of pain blocker medications into the nerves that are responsible for the sensations the abdominal wall.This procedure is c...
What is the current status of trial NCT03541941?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 164 participants. The study started on 2018-07-03. Estimated completion is 2019-12-19.
What interventions are being tested in trial NCT03541941?
The interventions under investigation include: Placebo (DRUG), Exparel (DRUG), Bupivacaine Hcl 0.25% Inj (DRUG).
Who is sponsoring clinical trial NCT03541941?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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