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NCT04872322
Effect of Ropivacaine During Popliteal Nerve Block in Foot and Ankle Surgery
Phase 3 trial testing Ropivacaine 0.5% Injectable Solution in Popliteal Nerve Block in 128 participants. Status unknown.
31 December 2021
Quick facts
| Lead sponsor | Rothman Institute Orthopaedics |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 128 |
| Start date | 31 August 2017 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ropivacaine 0.5% Injectable Solution — full drug profile →
- Ropivacaine 0.25% Injectable Solution — full drug profile →
- Percocet Pill — full drug profile →
- Norco Pill — full drug profile →
- Foot/Ankle Surgery
Conditions studied
- Popliteal Nerve Block — all drugs for Popliteal Nerve Block →
- Foot Surgery — all drugs for Foot Surgery →
- Ankle Surgery — all drugs for Ankle Surgery →
Sponsor
Rothman Institute Orthopaedics
Who can join
18 and older, any sex, with Popliteal Nerve Block or Foot Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
With the increasing rise of outpatient surgery in orthopaedic procedures, the management of immediate postoperative pain has been a major topic investigated, with the use of a peripheral nerve block in combination with general anesthesia being a commonly accepted method. Foot and ankle procedures, which offer the choice of several anesthetic techniques, have increasingly been performed with this method predominantly through the combination of general anesthesia with a single-injection popliteal nerve block to reduce the substantial acute postoperative pain that often requires large opioid intake within the post-anesthesia care unit (PACU). However, as a single-injection peripheral nerve block resolves off shortly following surgery, major postoperative pain, termed "rebound pain", can also arise, and has the potential to be even greater than that of patients who do not receive any peripheral nerve block with general anesthesia. The purpose of this study is to evaluate the contribution of ropivacaine concentration (0.5% versus 0.25%) of the initial bolus in continuous popliteal nerve blocks toward the rebound pain phenomena, or the quantifiable difference in pain experienced during the initial time after block resolution, in foot and ankle surgeries.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04872322
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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 NCT04872322 (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 Rothman Institute Orthopaedics
- Last refreshed: 4 May 2021
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/NCT04872322.
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