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NCT04280939
Spinal Anesthetic for Hip and Knee Replacement Surgery - Intrathecal Morphine or Hydromorphone
NA trial testing spinal anesthesia in Spinal Anesthesia. Withdrawn.
31 March 2021
Quick facts
| Lead sponsor | Hopital Montfort |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Start date | 1 April 2020 |
| Primary completion | 31 March 2021 |
| Estimated completion | 31 March 2021 |
Drugs / interventions tested
- spinal anesthesia — full drug profile →
Conditions studied
- Spinal Anesthesia — all drugs for Spinal Anesthesia →
Sponsor
Hopital Montfort
Who can join
Adults 18 to 95, any sex, with Spinal Anesthesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In the current healthcare system, a short length of stay is paramount, for medical, functional, and financial reasons. Most patients undergoing hip and knee replacement at Hôpital Montfort institution receive spinal anesthetic, with intrathecal morphine for enhanced analgesia. However, morphine can cause urinary retention, nausea or vomiting resulting in increased length of stay (LOS). Based mainly on local experience, The investigators believe hydromorphone may be a good alternative (1). According to the literature review, no adult study compares morphine and hydromorphone. QUESTIONS Does intrathecal hydromorphone lead to equal or better pain control/post-operative function, with fewer side effects than morphine? OBJECTIVES. Primary objective: to demonstrate that hydromorphone is the choice narcotic for spinal anesthesia for arthroplasty patients. Secondary objectives: * increased patient satisfaction * decreased hospital length of stay METHODOLOGY The investigators propose a prospective randomized double-blind trial with three groups of 155 patients each undergoing total hip arthroplasty (THA), total knee arthroplasty (TKA), or unicompartmental knee arthroplasty (UKA), striving for similar proportions of each procedure in all three groups. * Group 1: spinal anesthetic with standard painkillers, without intrathecal narcotics (ie "placebo" group) * Group 2: spinal anesthetic with intrathecal morphine * Group 3: spinal anesthetic with intrathecal hydromorphone The primary outcome measure will be urinary retention. Secondary outcome measures will be nausea/vomiting, pain control, post-operative function and length of stay. RESULTS The investigators expect to show that intrathecal hydromorphone will provide the best combination of post-operative patient pain control and function, with diminished negative side effects. They hope to extrapolate this to a potential out-patient arthroplasty program.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04280939
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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 NCT04280939 (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 Hopital Montfort
- Last refreshed: 31 March 2022
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing