The Analgesic Efficacy of Nefopam in Orthopedics Surgery

NCT06680609 | Completed Early Phase 1

• 1 other identifier: 52/163/2023
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

opioid; nefopam; tourniquet; orthopedic

Outcome Measures

Primary Outcomes (2)

• The analgesic efficacy of nefopam

  The primary outcome was to compare the severity of pain at the site of surgery and at the site of tourniquet insertion by the use of an 11-point visual analogue scale ranging from 0 (no discomfort) to 10 points (most extreme discomfort).

  6 months

• Amount of opioids used intraoperatively

  The amount of opioids used intraoperatively and immediately postoperatively by calculating oral morphine equivalent

  6 months

Study Arms (2)

Nefopam group

PLACEBO COMPARATOR

Drug: Nefopam 20 MG/ML

Placebo

OTHER

Drug: Placebo

Interventions

Nefopam 20 MG/ML DRUG

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

Nefopam group

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients undergoing orthopedic surgery which involved usage of tourniquet under general anesthesia.
• Only patients aged 15-60 years

You may not qualify if:

• patients with any contraindication to nefopam
• surgery with tourniquet time more than 180 min
• patients on opioid medications
• patients with preexisting chronic pain syndromes
• patients refuse to participate in the study
• patients with psychiatric diseases.

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

King Abdullah University Hospital

Irbid, 22110, Jordan

Location

MeSH Terms

Conditions

Agnosia

Interventions

Nefopam

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 8, 2024
• Study Start: June 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: May 5, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)