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Assessment of efficacy of Single dose of Gabapentin, immediately after the surgery

Assessment of efficacy of Single dose of Gabapentin, immediately after the surgery in patients who have been undergoing internal fixation of tibia under spinal anesthesia, in reducing acute post operative pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201108173773N3
Enrollment
64
Registered
2011-12-23
Start date
2010-03-21
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

Lower Limb Pain. Pain in lower limb

Interventions

Intervention 1: In intervention group after the surgery (internal fixation of tibia) and arriving the recovery room and passing the time required for obtaing the necessary criteria for drinking and sw
Treatment - Drugs
In intervention group after the surgery (internal fixation of tibia) and arriving the recovery room and passing the time required for obtaing the necessary criteria for drinking and swallow tablet, on
In control group after the surgery (internal fixation of tibia) and arriving the recovery room and passing the time required for obtaing the necessary criteria for drinking and swallow tablet, one pla

Sponsors

Vice chancellor for Research, Tehran University of Medical Sciences and Health Services
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: ASA class 1&2, Surgery on tibia bone, Operation duration: 120-150 minute Exclusion criteria: Allergy to Gabapentin, Convulsion history, Previous treatment by Gabapentin, Psychiatric disorders, Addiction, Liver & Kidney disease, Chronic Pain syndrome, Analgesic drug consumption during 24h, Dissatisfaction to spinal anesthesia, Vomiting after Gabapentin tablet.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain of Tibia bone (leg). Timepoint: 2, 12 and 24 hours postoperatively. Method of measurement: visual analogue scale (VAS).

Secondary

MeasureTime frame
Analgesic (morphine) administered. Timepoint: 2, 12 and 24 hours postoperatively. Method of measurement: miligram.;Time duration from the end of surgery until the first analgesic requirement. Timepoint: after surgery. Method of measurement: hour.;Side effect. Timepoint: After operation. Method of measurement: Patient examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarsad Imani

Tehran University of Medical Sciences, Anesthesia Group

imanifar@tums.ac.ir+98 21 63120

Outcome results

None listed

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