The effect of adding a very low dose of naloxone to remifentanil infusion on pain

Addition of a very low dose of naloxone to remifentanil infusion on postoperative pain in patients undergoing total hip replacement surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220111053694N1

Enrollment

Registered

2022-08-07

Start date

2021-02-19

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Patients undergoing complete hip replacement surgery. Presence of orthopaedic joint implants

Interventions

Intervention 1: Intervention group: In the intervention group, naloxone (Caspian tamin pharmaceutical co) with a very low dose (0.05 µg/kg/h) was added to remifentanil (Exir pharmaceutical co) infusio

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: In this study, clinical trial of patients undergoing hip replacement surgery under general anesthesia No contraindications for general anesthesia No chronic pain Between 18 and 65 years With physical condition ASA I-II (scoring status Physical, American Society of Anesthesiologists) Filled out a written informed consent form

Exclusion criteria

Exclusion criteria: Obesity (BMI = 30 kg / m2 ) Pregnancy (based on B-HCG check) Dependence on drugs and alcohol Use of any painkillers in the last 24 hours Unusual bleeding Ischemic heart disease History of seizures Decrease or increase in blood pressure by more than 30% of baseline Any surgical complications such as prosthetic fractures or enlargement of the surgery due to extensive fractures of the pelvis Postoperative exclusion criteria include reoperation Excessive bleeding Long-term ventilation (> 12 hours)

Design outcomes

Primary

Measure	Time frame
The patient's pain level. Timepoint: before the intervention and 4, 8, 12 and 24 hours after the intervention. Method of measurement: VAS scale (Based on this scale, a score between 1-10 is defined for the patient's pain).	—

Secondary

Measure	Time frame
Need to be sedated. Timepoint: The need for other painkillers after surgery to reduce the patient's pain. Method of measurement: Checklist.;Time to first sedative. Timepoint: after surgery. Method of measurement: Checklist based on the patient's needs and pain.;Cumulative dose of painkiller used. Timepoint: The first 24 hours after the surgery. Method of measurement: Checklist (total dose used).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeid Jamalie Bastami

Mashhad University of Medical Sciences

dr.saeidjamalie98@gmail.com+98 51 3884 4186

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026