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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: Completed Phase 4 study, sponsored by The Cleveland Clinic.

NCT03541941 is a Phase 4 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 164 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Measured in milligrams or micrograms as appropriate and converted to oral morphine equivalent daily dose. The cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparations will be recorded. Such assessment will be performed at the 3rd postoperative day (72 hours of operation).

Interventions

  • DRUG Placebo
  • DRUG Exparel
  • DRUG Bupivacaine Hcl 0.25% Inj

Trial Details

FieldValue
Enrollment Target 164 participants
Start Date 2018-07-03
Est. Completion 2019-12-19
Phase Phase 4
The Cleveland Clinic

688 total trials

What the finished NCT03541941 record still lists

NCT03541941 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03541941 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03541941's enrollment target sits among peer trials

164 496th of 2000 higher than 1,500 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03541941, the US trial registry maintained by the National Library of Medicine. NCT03541941 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.