Analgesic efficacy of Nefopam after Arthroscopic Anterior cruciate ligament reconstruction surgery: A Prospective, Tripple-blind, randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240412003

Enrollment

Registered

2024-04-12

Start date

2024-05-02

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain in Patients who have anterior cruciate ligament tear and plan to undergo Arthroscopic Anterior cruciate ligament reconstruction surgery Nefopam, Anterior cruciate ligament tear, AACLR

Interventions

The participants in group N will receive a first dose of nefopam (20 mg of nefopam in 0.9% NSS total 100 ml IV infuse in 30 minutes) before closing the surgical incision. Then, the next doses will be

Active Comparator Drug,Placebo Comparator Other

Nefopam,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who are over 18 years old with ASA PS between 1 and 3 and are required for Anterior Cruciate ligament reconstruction with hamstring graft.

Exclusion criteria

Exclusion criteria: - Patients refuse to participate - Previous surgery of ipsilateral knee - Allergy to study drugs; nefopam, adrenaline, ketorolac, transamine, opioids, or paracetamol - Pre-existing neuropathy at the affected limb - Contraindications to nefopam such as history of convulsive disorders, urinary retention linked to urinary or prostate disorders, angle-closure glaucoma - Chronic opioid used - Contraindication to other study drugs - Inability to report pain scores or unable to use IV PCA device

Design outcomes

Primary

Measure	Time frame
Pain score 24 hours Verbal Numerical rating scale at 24 hours postoperatively	—

Secondary

Measure	Time frame
Pain score 6, 12, 18 and 24 hours Verbal Numerical rating scale at rest at 6, 12, 18 and 24 hours postoperatively,Pain score 6, 12, 18, and 24 hours Verbal Numerical rating scale at passive motion (knee flexion 60 degrees) at 6, 12, 18, and 24 hours postoperatively,Morphine consumption 6, 12, 18, and 24 hours Morphine consumption 6, 12, 18, and 24 hours postoperatively,Morphine consumption 24 hours Accumulative morphine consumption within 24 hours,Side effects 24 hours Side effects and adverse events and sedation scores at 24 hours postoperatively,Functional outcomes, QOR-15 24 hours Functional outcomes, QOR-15, satisfaction at 24 hours postoperatively	—

Measure

Time frame

Pain score 6, 12, 18 and 24 hours Verbal Numerical rating scale at rest at 6, 12, 18 and 24 hours postoperatively,Pain score 6, 12, 18, and 24 hours Verbal Numerical rating scale at passive motion (knee flexion 60 degrees) at 6, 12, 18, and 24 hours postoperatively,Morphine consumption 6, 12, 18, and 24 hours Morphine consumption 6, 12, 18, and 24 hours postoperatively,Morphine consumption 24 hours Accumulative morphine consumption within 24 hours,Side effects 24 hours Side effects and adverse events and sedation scores at 24 hours postoperatively,Functional outcomes, QOR-15 24 hours Functional outcomes, QOR-15, satisfaction at 24 hours postoperatively

—

Countries

Thailand

Contacts

Public ContactWiset Tangphromphan

Khon Kaen University

Wiseta@kku.ac.th0819740175

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026