drugset / Trial / NCT03428230
Intrathecal Paracetamol Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Short Knee Procedures
RandomizedParallel-groupTriple-blindSupportive care
Summary
This is a phase II, single centre, randomised, parallel-group, double-blind, three doses, placebo-controlled, exploratory efficacy and safety study. The objective of this study is to investigate the efficacy and safety of a single intrathecal injection of Paracetamol 3% (30 mg/mL) administered at 3 doses to 3 active treatment groups, as compared to placebo, for post-operative analgesia in knee procedures up to 40 min duration performed under spinal anaesthesia with Chloroprocaine HCl 1%.
Timeline
- Start
- 2018-08-06
- Primary completion
- 2019-10-22
- Completion
- 2019-10-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 30 mg | Intrathecal |
| Subject | Acetaminophen | Small molecule | 60 mg | Intrathecal |
| Subject | Acetaminophen | Small molecule | 90 mg | Intrathecal |
| Background | Chloroprocaine | Other / unclassified | — | Intrathecal |