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The Analgesic Efficacy of Nefopam in Orthopedics Surgery

NCT06680609 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-11-08

No results posted yet for this study

Summary

Pain-free and relief are one of the anesthesiologist's most important concerns during the operation. General aim is always to effectively control pain but while simultaneously reducing opioid requirements to reduce opioid related side effects and mortality. Patients undergoing orthopedic operations tend to have high pain scores and analgesic requirements. In this study, the investigators aim to investigate the effect of adding nefopam on reducing the postoperative pain scores and the need for opioids.

This double-blind placebo-controlled prospective study aims to determine the effectiveness of nefopam in relieving the pain resulting from the operation in addition to the pain resulting from tourniquet. The unlabeled drug solution was administered one at the beginning of surgery. A 10 mL solution containing nefopam 20 mg or placebo diluted with normal saline was infused over 20 min. 11-point visual analogue scale was utilized to assess the pain score.

Conditions

  • Pain Management
  • Orthopedic Procedure Pain

Interventions

DRUG

Nefopam 20 MG/ML

The unlabeled interventional drug solution was administered one at the beginning of surgery. A 10 mL solution containing nefopam 20 mg was infused over 20 min

DRUG

Placebo

The unlabeled interventional drug solution was administered one at the beginning of surgery. A 10 mL solution containing placebo diluted with normal saline was infused over 20 min

Sponsors & Collaborators

  • Jordan University of Science and Technology

    collaborator OTHER

  • King Abdullah University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-12-31
Completion
2024-05-05

Countries

  • Jordan

Study Locations

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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 NCT06680609 on ClinicalTrials.gov