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Pain control and complications check at two groups, 300 mg single dose of Pregabalin with 900 mg single dose of Gabapentin

Compare 300 mg single dose of pregabalin whit 900 mg single dose of gabapentin in orthopedic closed leg fracture post operative pain control and complications check at two groups.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201502126186N7
Enrollment
160
Registered
2015-04-09
Start date
2015-06-12
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

Leg close fracture. Fractures of other parts of lower leg

Interventions

Intervention 1: Intervention 1: 300 mg Pregabalin 1 houre before spinal anesthesia. Intervention 2: Intervention 2: 900mg gabapentin 1 houre before spinal anesthesia.
Treatment - Drugs
Intervention 1: 300 mg Pregabalin 1 houre before spinal anesthesia
Intervention 2: 900mg gabapentin 1 houre before spinal anesthesia

Sponsors

Vice chancellor for research of Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
17 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age between 17_65 years old; BMI<30; ASA I,II; candidate for orthopedic closed leg fracture operation with spinal anesthesia. and exclusion criteria: coagulation disturbance; sever hemodynamic instability; history of head trauma; infection and skin lesion at lumbosacral area; addiction, liver or renal or cardiac disease; history of drug reaction to local anesthetic and opium and patient dissatisfaction for spinal anesthesia.

Exclusion criteria

Exclusion criteria:

Design outcomes

Secondary

MeasureTime frame
Vertigo. Timepoint: At recovery room, 6 and 12 hours after surgery. Method of measurement: VAS score.

Primary

MeasureTime frame
Pain. Timepoint: At recovery room, 6 and 12 hours after surgery. Method of measurement: VAS score.;Being sleepy. Timepoint: At recovery room, 6 and 12 hours after surgery. Method of measurement: Sedation score.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBahram Naderi Nabi

Guilan University of Medical Sciences

aecguilan1392@gmail.com+98 13 3331 0434

Outcome results

None listed

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