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Effect of oral gabapentin versus placebo on pain relief after gynecologic surgery

Effect of oral gabapentin versus placebo on pain relief after gynecologic surgery: a triple blinded randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201402289014N28
Enrollment
102
Registered
2014-05-26
Start date
2014-06-22
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

Pain at surgical site at inguinal area. Pain localized to other parts of lower abdomen

Interventions

Intervention 1: 34 patients will receive two gabapentin capsules 300 mg (600 mg) single dose 2 hours before surgery. Intervention 2: 34 patients will receive one gabapentin capsule 300 mg plus one pla
Treatment - Drugs
Placebo
34 patients will receive two gabapentin capsules 300 mg (600 mg) single dose 2 hours before surgery
34 patients will receive one gabapentin capsule 300 mg plus one placebo capsule (containing starch) single dose 2 hours before surgery
34 patients will receive two placebo capsules (containing starch) single dose 2 hours before surgery

Sponsors

Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (a) age of 18 to 65 years; (b) women with physical class ASA I-II; (c) candidate for elective gynecologic surgery. Exclusion criteria: (a) contraindication for neuroaxial anesthesia; (b) history of hypertension or diabetes mellitus; (c) using narcotics or psychotropic.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain at the surgical site. Timepoint: at 1, 6, 12, 18, 24, and 48 hours after surgery. Method of measurement: using VAS scale.;The amount of narcotic used. Timepoint: during the first 48 hours after surgery. Method of measurement: per mg.;The duration of time to receive narcotic. Timepoint: during the first 48 hours after surgery. Method of measurement: per min.

Secondary

MeasureTime frame
Vertigo. Timepoint: at 1, 6, 12, 18, 24, and 48 hours after surgery. Method of measurement: by question.;Nausea and vomiting. Timepoint: at 1, 6, 12, 18, 24, and 48 hours after surgery. Method of measurement: by question.;Pruritus. Timepoint: at 1, 6, 12, 18, 24, and 48 hours after surgery. Method of measurement: by question.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Parisa Shirzad

Beasat Hospital

shirzad.parisa7@gmail.com+98 81 1341 6392

Outcome results

None listed

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