NCT02654860View on ClinicalTrials.gov

Dose-finding Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

February 28, 2019

Study Completion Date

February 28, 2019

Conditions
Phase 1: Pain ManagementPhase 2: Pain Management
Interventions
DRUG

Paracetamol 3%

Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery

DRUG

Placebo injection containing Saline solution 0.9%

Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.

DRUG

Hyperbaric Bupivacaine HCl 0.5%

NIMP, spinal anaesthetic before the surgical procedure

Trial Locations (1)

CH-6929

Claudio Camponovo, Gravesano

All Listed Sponsors
collaborator

Cross S.A.

INDUSTRY

lead

Sintetica SA

INDUSTRY

NCT02654860 - Dose-finding Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia | Biotech Hunter | Biotech Hunter