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Evaluation of adding intrathecal fentanyl and dexmedetomidine on postoperative analgesia

Comparison of the analgesic effect of intrathecal dexmedetomidine versus fentanyl in opioid dependence undergoing lower limb orthopedic surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110313006044N4
Enrollment
75
Registered
2020-09-24
Start date
2020-09-30
Completion date
Unknown
Last updated
2020-10-06

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

Conditions

Lower limb sugary. Unspecified fracture of lower leg

Interventions

Intervention 1: First Intervention group: 12.5 mg bupivacaine 0.5% hyperbaric with 5 micrograms dexmedetomidine via intrathecal injection. Intervention 2: Second Intervention group: 12.5 mg bupivacain

Sponsors

Bandare-abbas University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Addict patients with aged 18-65 years andASA II, I Candidate for lower limb orthopedic surgery under spinal anesthesia

Exclusion criteria

Exclusion criteria: Emergency surgeries Patients with severe valvular heart disease Patients with psychological disorders Patients with a history of seizures Patients with ASA > II Patients with a history of allergy tothe drugs used Patients with a ban on spinal anesthesia (coagulation problems, high ICP, sepsis, infection at the injection site) Patients with neurological defects Patients who fail the block and need to induce general anesthesia

Design outcomes

Primary

MeasureTime frame
Postoperative analgesia. Timepoint: Patients' pain intensity is measured and recorded based on visual analog scale (VAS) in recovery during 2,4,6,12 hours after surgery. Method of measurement: Patients' severity of pain is based on the Visual Analogues Scale, with the left side indicating no pain and the right side showing the number "10" indicating the most severe pain. Score style 1-3 indicates mild pain, 4-7 moderate pain, severe pain 8-10), duration of analgesia from time to block until patient requests for analgesics.

Secondary

MeasureTime frame
Side effects after surgery including nausea and vomiting and. Timepoint: During surgery and in recovery between 2,4,6,12 hours after surgery is measured and recorded. Method of measurement: Patient dissatisfaction.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHashem Jarineshin

Bandare-abbas University of Medical Sciences

Hjarineshin@yahoo.com+98 76 3334 5009

Outcome results

None listed

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