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

NCT02654860 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2021-10-27

Study results available
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Summary

Two-part study of intrathecal paracetamol administered immediately before spinal anaesthesia in patients scheduled for hip replacement surgery

Conditions

  • Phase 1: Pain Management
  • Phase 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

Sponsors & Collaborators

  • Cross S.A.

    collaborator INDUSTRY

  • Sintetica SA

    lead INDUSTRY

Principal Investigators

  • Claudio Camponovo, MD · Department of Anaesthesiology,Clinica Ars Medica,Via Cantonale, CH-6929 Gravesano, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02654860 on ClinicalTrials.gov