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NCT04112550
Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions
Phase 1 trial testing Methadone Hydrochloride in Degenerative Disc Disease in 150 participants. Status unknown.
31 December 2021
Quick facts
| Lead sponsor | The Methodist Hospital Research Institute |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 11 February 2020 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
Drugs / interventions tested
- Methadone Hydrochloride (METHADONE) — full drug profile →
- Oxycodone-Acetaminophen
Conditions studied
- Degenerative Disc Disease — all drugs for Degenerative Disc Disease →
- Spondylolisthesis, Lumbar Region — all drugs for Spondylolisthesis, Lumbar Region →
Sponsor
The Methodist Hospital Research Institute
Who can join
Adults 18 to 70, any sex, with Degenerative Disc Disease or Spondylolisthesis, Lumbar Region. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Spinal operations including lumbar fusions for degenerative disorders are becoming more prevalent as the population ages. Inadequate or excessive postoperative analgesia can result in medical comorbidities and prolonged hospital length of stay and patient dissatisfaction. Existing literature has highlighted the preoperative administration of methadone as a promising adjuvant for post operative pain control. Methadone has the benefit of being long-acting and has more stable serum concentration and a single preoperative dose may have significant benefits post operatively. Here the investigators propose a prospective parallel-group, randomized, double-blinded study to assess post operative analgesic requirements after preoperative administration of either methadone 15 mg or Oxycodone 10/325. Primary outcome will be total IV and PO narcotic consumption in the post operative course. Secondary outcomes examined will include time to mobility, need for specialist pain management consultation, early readmission (within 2 weeks) for inadequate pain control, and complications associated with administration.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04112550
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other trials of Methadone Hydrochloride
Trials testing the same drug.
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- NCT04680286 — Intraoperative Methadone in Children Undergoing Surgery · Phase 3 · terminated
- NCT02989597 — Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients · Phase 4 · terminated
- NCT02531906 — Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II- · Phase 1 · completed
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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 NCT04112550 (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 The Methodist Hospital Research Institute
- Last refreshed: 29 January 2020
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