The efficacy of bupfentanyl in spinal anesthesia of patients with proximal ureteral stones

Comparison of the efficacy of 0.5% bupivacaine with and without fentanyl in spinal anesthesia of patients with proximal ureteral stones under transureteral lithotripsy (TUL)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210206050260N1

Enrollment

Registered

2021-04-17

Start date

2021-04-05

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

Spinal anesthesia.

Interventions

Intervention 1: Intervention group: Spinal injection of bupivacaine 10 mg with 0.5 ml fentanyl (25µg). Intervention 2: Control group: Spinal injection of bupivacaine 10 mg with 0.5 ml of normal saline

Eligibility

Sex/Gender

All

Age

15 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with ASA (American Society of Anesthesiologists) Class I and II

Exclusion criteria

Exclusion criteria: History of chronic pain Patients with multiple trauma Long-term use of painkillers Drug abuse History of alcohol consumption Having a prohibition (absolute or partial) for intrathecal injection Allergies to bupivacaine and fentanyl

Design outcomes

Primary

Measure	Time frame
Level of sensory block. Timepoint: Every 15 minutes during surgery and recovery. Method of measurement: With Pin Prick test.;Level of movement block. Timepoint: Every 15 minutes during surgery and recovery. Method of measurement: With Bromage Scale.;Degree of relaxation. Timepoint: Every 15 minutes during surgery and recovery. Method of measurement: With Ramsay Score.	—

Secondary

Measure	Time frame
Operative time. Timepoint: At the end of the surgery. Method of measurement: Stopwatch.;Complications of anesthesia. Timepoint: After surgery, during the period of hospitalization. Method of measurement: Question from the patient, examination.;The level of pain. Timepoint: After surgery, during the period of hospitalization. Method of measurement: With VAS score.;Recovery time. Timepoint: From the beginning of entering the recovery to the time of leaving it. Method of measurement: Stopwatch.;Blood pressure. Timepoint: Immediately after spinal injection every 2 minutes to 10 minutes and then every 5 minutes until the end of surgery then repeatedly in the recovery and the ward. Method of measurement: By intraoperative monitoring and postoperative sphygmomanometer.;Heartbeat. Timepoint: Every 5 minutes during the operation. Method of measurement: By intraoperative monitoring.	—

Measure

Time frame

Operative time. Timepoint: At the end of the surgery. Method of measurement: Stopwatch.;Complications of anesthesia. Timepoint: After surgery, during the period of hospitalization. Method of measurement: Question from the patient, examination.;The level of pain. Timepoint: After surgery, during the period of hospitalization. Method of measurement: With VAS score.;Recovery time. Timepoint: From the beginning of entering the recovery to the time of leaving it. Method of measurement: Stopwatch.;Blood pressure. Timepoint: Immediately after spinal injection every 2 minutes to 10 minutes and then every 5 minutes until the end of surgery then repeatedly in the recovery and the ward. Method of measurement: By intraoperative monitoring and postoperative sphygmomanometer.;Heartbeat. Timepoint: Every 5 minutes during the operation. Method of measurement: By intraoperative monitoring.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Khoshrang

Rasht University of Medical Sciences

hkhoshrang@yahoo.com+98 13 3352 5259

Outcome results

None listed

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