Investigating the effect of fentanyl and sufentanil as an adjuvant to ropivacaine on the quality of spinal anesthesia for lower limb orthopedic surgeries.

Comparing the effect of fentanyl and sufentanil as an adjuvant to ropivacaine on the quality of spinal anesthesia in lower limb orthopedic surgeries.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20131108015322N8

Enrollment

120

Registered

2024-11-03

Start date

2024-10-25

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

?Evaluation of the effect of fentanyl and sufentanil as an adjuvant to ropivacaine on the quality of spinal anesthesia in lower limb orthopedic surgeries.

Interventions

Intervention 1: Control group: intrathecal injection of 4 ml of 0.5% Ropivacaine plus 1 ml of distilled water. Intervention 2: Intervention group: intrathecal injection of 4 ml of 0.5% Ropivacaine pl

Eligibility

Sex/Gender

All

Age

16 Years to 70 Years

Inclusion criteria

Inclusion criteria: ASA ?-? patients Aged 70-16 years Having informed consent Candidates for lower limb orthopedic surgery

Exclusion criteria

Exclusion criteria: Patients with contraindications for spinal anesthesia. , 8-Surgeries lasting = one hour. Allergy to local anesthetics Drug abuse opium addiction Pregnant women Coagulation disorder BMI more than 35 Received narcotics before operation Surgeries lasting = one hour

Design outcomes

Primary

Measure	Time frame
Onset of effect and duration of sensory and motor block. Timepoint: After spinal anesthesia, the sensory and motor block is assessed every 5 minutes until the maximum level of block is created, and then the assessment continues every half hour until the end of the surgery. Method of measurement: The level of motor block is determined based on the Bromage scale of 0-3. The level of sensory block is determined by pinprick sensation.	—

Measure

Time frame

Onset of effect and duration of sensory and motor block. Timepoint: After spinal anesthesia, the sensory and motor block is assessed every 5 minutes until the maximum level of block is created, and then the assessment continues every half hour until the end of the surgery. Method of measurement: The level of motor block is determined based on the Bromage scale of 0-3. The level of sensory block is determined by pinprick sensation.

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Secondary

Measure	Time frame
Hemodynamic parameters. Timepoint: Every 5 minutes to 30 minutes after performing spinal block and then every 15 minutes until the end of the surgery. Method of measurement: Electrocardiogram, non-invasive blood pressure and pulse oximeter.;Return time of sensory and motor block. Timepoint: Every 30 minutes during surgery, in recovery room and every hour after surgery. Method of measurement: Motor block is evaluated by Bromage scale 0-3 and level of sensory block by needle test.;Pain intensity. Timepoint: The pain intensity is evaluated at 30 minutes intervals during operation , in the recovery room and every hour after entering the ward. Method of measurement: Numerical Rating Scale 0-10.;Side effects. Timepoint: During surgery, in recovery room and in surgery ward. Method of measurement: By observing.	—

Measure

Time frame

Hemodynamic parameters. Timepoint: Every 5 minutes to 30 minutes after performing spinal block and then every 15 minutes until the end of the surgery. Method of measurement: Electrocardiogram, non-invasive blood pressure and pulse oximeter.;Return time of sensory and motor block. Timepoint: Every 30 minutes during surgery, in recovery room and every hour after surgery. Method of measurement: Motor block is evaluated by Bromage scale 0-3 and level of sensory block by needle test.;Pain intensity. Timepoint: The pain intensity is evaluated at 30 minutes intervals during operation , in the recovery room and every hour after entering the ward. Method of measurement: Numerical Rating Scale 0-10.;Side effects. Timepoint: During surgery, in recovery room and in surgery ward. Method of measurement: By observing.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShideh Dabir

Shahid Beheshti University of Medical Sciences

shdabir@yahoo.com+98 21 2243 2595

Outcome results

None listed

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