Comparison of the Effect of Oral Diclofenac Tablets and Zintoma Capsules on Post-Spinal Anesthesia Pain

Comparison of the Effect of Oral Diclofenac Tablets and Zintoma Capsules on Post-Spinal Anesthesia Pain in Patients with Lower Limb Fractures

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220206053958N2

Enrollment

Registered

2025-12-04

Start date

2025-12-21

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Condition 1: Fracture of lower leg, including ankle. Condition 2: Headache after spinal anesthesia. Fracture of lower leg, including ankle Spinal and epidural anesthesia-induced headache during labor and delivery

Interventions

Intervention 1: Intervention group: Participants in the intervention group will receive Zintoma 250 mg capsules, manufactured by Gol Daru Pharmaceutical Company (Isfahan, Iran). Each capsule contains

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Age 18 to 40 years Lower limb fracture surgery with spinal anesthesia Headache

Exclusion criteria

Exclusion criteria: History of seizures and epilepsy History of alcohol and drug addiction History of cardiovascular disease Pregnancy Body mass index greater than 40

Design outcomes

Primary

Measure	Time frame
Postoperative headache. Timepoint: Immediately after taking the pill and 8, 24 and 48 hours later. Method of measurement: Visual Analogue Scale.;Duration of headache. Timepoint: Immediately after taking the pill and 8, 24 and 48 hours later. Method of measurement: Patient report from the onset to the end of the headache.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Fazli

Karaj University of Medical Sciences

drhf_md@yahoo.com+98 26 3443 4700

Outcome results

None listed

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