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comparsion of the effect of bupivacaine in combination with sufentanil and epinephrine in patients under spainal anesthesia

Comparison of the effect of Sufentanil in combination with Bupivacaine or Epinephrine and Bupivacaine alone in patients under spinal anesthesia on onset and recovery of motor and sensory block for lower extremity surgeries

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014050717607N1
Enrollment
105
Registered
2015-08-16
Start date
2015-03-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Fracture of lower leg, including ankle. Fracture of lower leg, including ankle

Interventions

Intervention 1: fifteen milligrams of bupivacaine adding one milliliter normal saline intrathecal. Intervention 2: fifteen milligrams of bupivacaine adding five micrograms of sufentanil intrathecal. I
Placebo
Treatment - Drugs
fifteen milligrams of bupivacaine adding one milliliter normal saline intrathecal
fifteen milligrams of bupivacaine adding five micrograms of sufentanil intrathecal
fifteen milligrams of bupivacaine adding ten micrograms epinephrine intrathecal

Sponsors

Birjand University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: inclusion criteria: patients with lower extremity surgery; patients classified in American association of anesthesiologist one and tow groups; all patients between 18 to 50 years old. exclusion criteria: all patients reject spinal anesthesia; shock; sepsis; fever; coagulation system dysfunction; opium addiction; local infection in site of spinal needle insertion.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Onset of sensory block. Timepoint: every minutes after spinal anesthesia for twenty minutes. Method of measurement: stopwatch.;Onset of motor block. Timepoint: every minutes after spinal anesthesia fot twenty minutes. Method of measurement: stopwatch.;Recovery from sensory block. Timepoint: every five minutes one houre after spinal anesthesia. Method of measurement: stopwatch.;Recovery from motor block. Timepoint: every five minutes one houre after spinal anesthesia. Method of measurement: stopwatch.

Secondary

MeasureTime frame
Pain. Timepoint: six hours after end of surgery. Method of measurement: visual analog scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPooya Derakhshan

Birjand University of Medical Sciences

pooyaderakh@yahoo.com+98 56 3222 2600

Outcome results

None listed

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