The effect of adding lidocaine to morphine on pain intensity after unilateral knee prosthesis surgery

Evaluation of adding Lidocaine to Morphine in patient controlled analgesia on pain intensity after unilateral knee prosthesis surgery by spinal anesthesia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200718048125N2

Enrollment

Registered

2022-12-14

Start date

2022-11-27

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

Osteoarthritis of knee. Osteoarthritis of knee, unspecified

Interventions

Intervention 1: Control group: Spinal anesthesia

25-gauge spinal needle (Dr.J Tianjin Hanaco Medical Co. Tianjin, China) was introduced, then 0.5% Bupivacaine mixed with 0.2 mg of Adrenaline was injected at either the third or fourth lumbar epidural

Eligibility

Sex/Gender

All

Age

45 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients who are in American Society of Anesthesiologists(ASA) class 1 and 2 Patients who are between 45 and 75 years old Patients with a Body Mass Index(BMI) in the range of 20-25 Patients who undergo spinal anesthesia for surgery

Exclusion criteria

Exclusion criteria: Patients with a history of epilepsy Patients with known kidney disease Patients with heart block Patients with drug addiction Patients with medical histories that show sensitivity to lidocaine and opioid substances Patients with coagulation disorders Patients with skin infection at the injection site Patients who had a history of moderate to severe nausea and vomiting in the last 24 hours

Design outcomes

Primary

Measure	Time frame
Postoperative pain. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Visual Analogue Scale.;Heart rate. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Pulse oximetry.;Mean arterial pressure. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Clinical examination.;Postoperative nausea and vomiting. Timepoint: 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Clinical examination.;Oxygen saturation. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Pulse oximetry.;Systolic pressure. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Dial sphygmomanometer.;Diastolic pressure. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Dial sphygmomanometer.	—

Measure

Time frame

Postoperative pain. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Visual Analogue Scale.;Heart rate. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Pulse oximetry.;Mean arterial pressure. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Clinical examination.;Postoperative nausea and vomiting. Timepoint: 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Clinical examination.;Oxygen saturation. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Pulse oximetry.;Systolic pressure. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Dial sphygmomanometer.;Diastolic pressure. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Dial sphygmomanometer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Beyzaee

Islamic Azad University

hmd_beyzaii@yahoo.com+98 51 3225 6291

Outcome results

None listed

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