A clinical trial to study the effects of flupirtine maleate as compared to ibuprofen on pain relief in gynaecological day care surgeries.

A comparative study to evaluate the analgesic efficacy of Flupirtine maleate versus Ibuprofen in gynecological ambulatory surgeries - None

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/02/003392

Enrollment

Registered

2013-02-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Females 18-70 years Gynecological ambulatory surgeries ranging up to 60 minutes Health Condition 2: N958- Other specified menopausal and perimenopausal disorders

Interventions

Intervention1: Flupirtine maleate: subjects will receive 100 mg oral Flupirtine maleate tablet one hour prior to surgery and then TID for 48 hours after surgery Control Intervention1: Ibuprofen: subje

Eligibility

Inclusion criteria

Inclusion criteria: 18-70 years Body Mass Index 25-30 kg/m2 Gynecological ambulatory surgeries ranging up to 60 minutes American Society of Anaesthesiologist I-II

Exclusion criteria

Exclusion criteria: History of intake of any analgesics in past three days Known hypersensitivity to any of the drug under study Hepatic insufficiency Patient with impaired renal function Gastritis Coagulopathy Previous cerebral vascular accident history History of uncontrolled cardiopulmonary disease

Design outcomes

Primary

Measure	Time frame
Verbal categorical rating Pain scaleTimepoint: At 0, 2,4,6,8,12,24,48 hours after surgery (0 hour being the time of admission to post anaesthesia care unit(PACU) when the first pain measurement will be taken).	—

Secondary

Measure	Time frame
Effect of flupirtine maleate versus ibuprofen on patient sedation score patient satisfaction score requirement of rescue analgesics and any adverse effectsTimepoint: one year	—

Countries

India

Contacts

Public ContactDr Vanita Ahuja

vanitaanupam@yahoo.co.in09646121649

Outcome results

None listed

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