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NCT02969187 · ClinicalTrials.gov registry record · Phase 4

Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patient Undergoing Laparoscopic Bariatric Surgery

A Phase 4 study, sponsored by The Cleveland Clinic.

Completed
Registry status
Phase 4
Development phase
126
Enrollment target

NCT02969187 is a Phase 4 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 126 participants.

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The verdict

NCT02969187, a Phase 4 study, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
Phase 4
Development phase
126 participants
Enrollment target

Study Summary

Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain management, efforts are continuing to find effective methods to relieve pain after abdominal surgery. Although opioid is an effective analgesic it has opioid related adverse events (ORAEs). Bupivacaine should reduce postoperative pain but it has relatively shorter duration of action. Liposome bupivacaine (Exparel) has been approved as a single dose infiltration for longer postoperative period analgesic. It provides up to 72 hours analgesia postoperatively; results in lesser opioids usage and reduce the ORAEs. Transversus abdominis plane (TAP) block is a relatively new regional anesthetic technique. TAP blocks have been performed to reduce opioid use and control pain in several laparoscopic surgical procedures, including colorectal resections, cholecystectomy and bariatric surgery. The aim of this study is to study the opiate usage, pain and nausea post laparoscopic gastric bypass or sleeve gastrectomy using Exparel versus Bupivacaine as TAP block and port sites infiltration.

Interventions

  • DRUG Bupivacain
  • DRUG Saline
  • DRUG Exparel

Trial Details

FieldValue
Enrollment Target 126 participants
Start Date 2016-11
Est. Completion 2018-03-31
Phase Phase 4

Sponsor

The Cleveland Clinic

688 total trials

What the Registry Record Tells You About NCT02969187

The ClinicalTrials.gov registry entry for NCT02969187 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 126 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 Bupivacain is the first listed.

NCT02969187 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02969187 about?

NCT02969187 is a clinical study titled "Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patient Undergoing Laparoscopic Bariatric Surgery". Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain management, efforts are continuing to find effective methods to relieve pain after abdominal surgery. Although opioid is an effective analgesic it has opioid related adverse events (ORAEs). Bupivacaine should re...

What is the current status of trial NCT02969187?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 126 participants. The study started on 2016-11. Estimated completion is 2018-03-31.

What interventions are being tested in trial NCT02969187?

The interventions under investigation include: Bupivacain (DRUG), Saline (DRUG), Exparel (DRUG).

Who is sponsoring clinical trial NCT02969187?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.