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NCT03035656
Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion
Phase 4 trial testing Ropivacaine in Pain, Postoperative in 228 participants. Status unknown.
1 March 2022
Quick facts
| Lead sponsor | Horizon Health Network |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 228 |
| Start date | 1 March 2019 |
| Primary completion | 1 March 2022 |
| Estimated completion | 1 March 2022 |
Drugs / interventions tested
- Ropivacaine (ROPIVACAINE) — full drug profile →
- Saline
Conditions studied
- Pain, Postoperative — all drugs for Pain, Postoperative →
Sponsor
Horizon Health Network
Who can join
19 and older, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The following is a double blinded, randomized controlled clinical trial to test the hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single intra-operative epidural injection of Ropivaciane® will result in decreased postoperative pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2) Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if there are differences in pain management between MIS and open surgical procedures. The proposed study will add novel information to current knowledge by 1) exploring of the effects of intra-operative single epidural injection analgesic on patients receiving MIS compared to open surgery, and 2) investigate potential immediate and short-term functional improvements gained from intra-operative single injection of Ropivaciane®.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03035656
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Horizon Health Network trials
Trials by the same sponsor.
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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 NCT03035656 (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 Horizon Health Network
- Last refreshed: 21 February 2019
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/NCT03035656.
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