drugset / Trial / NCT03428230

Intrathecal Paracetamol Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Short Knee Procedures

NCT03428230

Phase 2 Completed 60 enrolled Sintetica SA Cross Research S.A. · collab
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

EvaluationDrugModalityDoseRoute
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

Indications