MedTrace Logo

Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative Pain After Elective Knee Surgery

NCT03493490 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-03-20

No results posted yet for this study

Summary

The clinical study is planned as a double-blind, randomised, placebo-controlled, parallel-group, single-centre exploratory clinical study with the aim to investigate the analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac only infusion. Included will be Patients receiving elective cruciate ligament surgery. The effectiveness will be measured by the use of additional analgesic medication via PCA during the first 24 hours postoperatively as well as by using a Visual Analogue Scale (VAS). Furthermore the local and systemic tolerability and safety of the clinical study medications (i.e. Neodolpasse® Infusion Solution and 75 mg diclofenac only infusion) will be assessed.

Conditions

  • Pain, Postoperative
  • Analgesic Adverse Reaction
  • Cruciate Ligament Rupture

Interventions

DRUG

Neodolpasse

Patients will receive two infusions containing 75 mg diclofenac and 30 mg orphenadrine citrate 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.

DRUG

Diclofenac

Patients will receive two infusions containing 75 mg diclofenac 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.

DRUG

Placebo

Patients will receive two physiologic saline infusions 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Oliver Kimberger, M.D. · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs

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 NCT03493490 on ClinicalTrials.gov