Evaluation of the effect of Quetiapine and Diclofenac in reducing pain in lower limb surgeries

Comparison of the effect of prophylactic administration of Quetiapine and Diclofenac sodium on pain relief after major lower limb and pelvic surgeries under spinal anesthesia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160307026950N36

Enrollment

105

Registered

2021-10-14

Start date

2021-10-23

Completion date

Unknown

Last updated

2021-11-01

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

Conditions

Amount of post operation pain.

Interventions

Intervention 1: Intervention group A: In this group, patients who have not eaten for at least 8 hours before the operation receive 50 mg of oral Quitiapine 30 minutes before induction of anesthesia an

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 18 to 64 years ASA Class I and II Anesthesia Candidate for major lower limb and pelvic surgeries Candidate for spinal anesthesia Patient informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Taking psychotropic or sedative drugs Opioid and non-opioid drug addiction Diabetes, orthostatic hypotension, bradycardia, hypokalemia, hypothyroidism, depression, dementia, prolonged QT syndrome Pregnancy and lactation Obesity (BMI>30)

Design outcomes

Primary

Measure	Time frame
The severity of postoperative pain. Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: Visual Analogue Scale (0 to 10).	—

Secondary

Measure	Time frame
Moderate arterial blood pressure. Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: Barometer.;Heart Rate. Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: ECG.;Arterial blood oxygen saturation. Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: Pulse oximeter.;Complications (such as nausea, vomiting, dizziness, drowsiness, headache). Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: Asking.	—

Measure

Time frame

Moderate arterial blood pressure. Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: Barometer.;Heart Rate. Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: ECG.;Arterial blood oxygen saturation. Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: Pulse oximeter.;Complications (such as nausea, vomiting, dizziness, drowsiness, headache). Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: Asking.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh Erfani

Esfahan University of Medical Sciences

Azadeherf18@gmail.com+98 31 3620 2020

Outcome results

None listed

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