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NCT05082155
Continuous Erector Spinae Plane Blocks to Treat Postoperative Pain After Open Gynecologic Procedures Via a Low Transverse (Pfannenstiel) Incision
Phase 4 trial testing Bupivacaine 0.25% in Surgical Incision. Withdrawn.
24 May 2022
Quick facts
| Lead sponsor | University of California, San Diego |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Start date | 1 January 2022 |
| Primary completion | 24 May 2022 |
| Estimated completion | 24 May 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Bupivacaine 0.25% — full drug profile →
- Normal Saline
Conditions studied
- Surgical Incision — all drugs for Surgical Incision →
- Pain, Postoperative — all drugs for Pain, Postoperative →
- Pain, Acute — all drugs for Pain, Acute →
Sponsor
University of California, San Diego
Who can join
18 and older, female only, with Surgical Incision or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Open gynecologic surgery can be very painful. With the goal of minimizing the use of opioids (with undesired side effects and potential for abuse), the investigators often administer a type of peripheral nerve block in which the investigators put local anesthetic-or, numbing medicine-near the nerves that go to the surgical area which helps to numb the area and decrease pain following surgery. These blocks with a single-injection of local anesthetic are called erector spinae plane (ESP) blocks, and they are applied on each side of the body since each injection affects only that one side. However, the numbing medication typically lasts for only 16-20 hours. For other peripheral nerve blocks, this duration can be increased with the insertion of a catheter-a tiny tube smaller than a piece of spaghetti-followed by an infusion of additional local anesthetic. However, the effects of the various peripheral nerve blocks are determined by the anatomy and physiology of the specific peripheral nerve, with an infusion resulting in dramatic benefits for one nerve yet having no effect for another. The potential benefits and risks of adding a catheter and subsequent local anesthetic infusion to a single-injection ESP block remain unknown. The investigatorstherefore propose a randomized, triple-masked, placebo-controlled, split-body clinical trial to determine the potential benefits and risks of adding the infusion to single-injection ESP blocks.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05082155
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Related trials
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Trials testing the same drug.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05082155 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Diego
- Last refreshed: 31 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05082155.
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