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NCT04525898
Intraoperative Methadone for Postoperative Pain Control After Thoracic Surgery
Phase 4 trial testing Methadone in Postoperative Pain in 40 participants. Terminated before completion.
1 February 2021
Quick facts
| Lead sponsor | Endeavor Health |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 40 |
| Start date | 9 October 2019 |
| Primary completion | 1 February 2021 |
| Estimated completion | 1 February 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Methadone (METHADONE) — full drug profile →
Conditions studied
- Postoperative Pain — all drugs for Postoperative Pain →
Sponsor
Endeavor Health — full company profile →
Who can join
Adults 18 to 80, any sex, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pain following surgery continues to be an important adverse outcome that may impact postoperative recovery. Opioids like fentanyl and hydromorphone are the primary medications used to provide analgesia, but paradoxically, may actually worsen pain when administered in the operating room. Methadone is a unique opioid which has N-methyl-D-aspartate (NMDA) receptor blocking properties, which may prevent the development of opioid-induced tolerance and hyperalgesia (increased sensitivity to pain induced by a drug). Studies have demonstrated that methadone reduces the need for analgesic medications and decreases pain after surgery. Furthermore, the addition of methadone to a standard anesthetic has been demonstrated to increase patient satisfaction with pain management and reduce the need for opioid analgesic medications during the first month after surgery. Some investigators have described methadone as a "opioid-sparing opioid" and recommended its use as part of a multimodal pain management strategy. There is a growing interest in reducing the use of traditional opioids in the operating room. The aim of this clinical trial is to compare pain scores and analgesic requirements in two groups of patients; one group will be randomized to receive a small dose of methadone at the start of surgery. The other group will be randomized to receive an equal volume of saline (salt water-control group) at the start of surgery. We hypothesize that patients randomized to be administered methadone at the start of surgery will have less postoperative pain and may require lower doses of pain medications than those given saline-control..
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04525898
- Europe PMC full search
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Related trials
Other trials of Methadone
Trials testing the same drug.
- NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
- NCT07227064 — Methadone in THA for Post-op Pain and Opioid Reduction · Phase 3 · recruiting
- NCT06868589 — Reducing Pain With Methadone and Ketamine in Liver Transplant · Phase 4 · active not recruiting
- NCT06810336 — Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery · EARLY_PHASE1 · not yet recruiting
- NCT06576830 — Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia · Phase 4 · recruiting
Other recruiting trials for Postoperative Pain
Currently open trials in the same condition.
- NCT07452120 — DIPB vs. SIFIB for Postoperative Analgesia After Hip Surgery · NA · recruiting
- NCT07396688 — Comparative Evaluation of the Effects of Calcium Hydroxide and BIO-C Temp Medicaments on Postoperative Pain in Patients · NA · recruiting
- NCT07413055 — Comparative Efficacy Of 4 mg VS. 8 mg Submucosal Dexamethasone In Postoperative Pain Management After Dental Implant Sur · Phase 3 · recruiting
- NCT07496086 — External Oblique Intercostal Block Versus Transversus Abdominis Plane Combined With Rectus Sheath Block on Postoperative · NA · recruiting
- NCT07396545 — External Oblique Intercostal Block Versus Erector Spinae Plane Block on Postoperative Pain in Laparoscopic Radical Gastr · NA · recruiting
Other Endeavor Health trials
Trials by the same sponsor.
- NCT06258785 — Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension · Phase 3 · completed
- NCT06279195 — Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment · Phase 2 · withdrawn
- NCT05921149 — Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer · NA · not yet recruiting
- NCT05747027 — Prospective Randomized Controlled Trial of Obstructed Defecation Surgery · NA · terminated
- NCT06062875 — Effects of TNF Blockade on Human BPH/LUTS · Phase 2 · recruiting
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 NCT04525898 (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 Endeavor Health
- Last refreshed: 21 December 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/NCT04525898.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing