At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 69 enrolled

Drug / intervention

Paracetamol 3% +2 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02654860

NCT02654860Phase 2Completed

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Two-part Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia in Patients Scheduled for Hip Replacement Surgery

Sintetica SA·interventional·Posted Jan 13, 2016·Updated Oct 27, 2021

In Brief

A Phase 2 clinical trial evaluating Paracetamol 3%, Placebo injection containing Saline solution 0.9%, and 1 other intervention for Phase 1: Pain Management and Phase 2: Pain Management. Completed, enrolled 69 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPhase 1: Pain Management, Phase 2: Pain Management

CountriesSwitzerland

CollaboratorsCross S.A.

Timeline

Phase 2CompletedFinished

20162017201820192020202120222023202420252026

First PostedJan 2016

Enrollment StartNov 2016

Primary CompletionFeb 2019

TodayJul 2026

First PostedJan 13, 2016

Enrollment StartNov 1, 2016

Primary CompletionFeb 1, 2019

TodayJul 2, 2026

Enrollment to primary: 2.3 yearsPosted 10.5 years ago

Interventions

Paracetamol 3%drug

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

Placebo injection containing Saline solution 0.9%drug

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.

Hyperbaric Bupivacaine HCl 0.5%drug

NIMP, spinal anaesthetic before the surgical procedure