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Comparative Preemptive Analgesic Effects of Pregabalin with and without Vitamin B1 in orthopedic surgery

Comparative Preemptive Analgesic Effects of Pregabalin with and without Vitamin B1 in orthopedic surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090902002405N11
Enrollment
90
Registered
2026-01-14
Start date
2026-01-21
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Preemptive Analgesia on orthopedic post-operative pain.

Interventions

Intervention 1: Intervention group: patients receive 150 mg pregabalin tablets along with 300 mg vitamin B1 tablets one hour before surgery. Intervention 2: Control group: patients receive 150 mg preg

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patients who are candidates for orthopedic foot surgery under general anesthesia American Society of Anesthesiologists(ASA) physical status class I–II Patient age between 18 and 64 years. Written informed consent to participate in the study Surgical procedures with a duration of less than three hours

Exclusion criteria

Exclusion criteria: Hypersensitivity or allergy to any of the study medications. Patients receiving corticosteroid therapy. History of using analgesic, opioid, or sedative medications prior to surgery. History of chronic pain–related conditions (such as fibromyalgia or chronic neuropathic pain).

Design outcomes

Primary

MeasureTime frame
Pain scores. Timepoint: upon admission to the post-anesthesia care unit and at 8 and 24 hours after the end of surgery. Method of measurement: Visual Analogous Scale (VAS) and scoring from 0 to 100.

Secondary

MeasureTime frame
Frequency of postoperative nausea and vomiting(PONV). Timepoint: The first 24 hours after surgery. Method of measurement: Note by the nurse.;The mean of the first analgesic duration. Timepoint: The first analgesic duration. Method of measurement: Note by the nurse.;Morphine milligram Equivalent(MME). Timepoint: The first 24 hours after surgery. Method of measurement: Note by the nurse.;The Mean number of analgesic consumption. Timepoint: 24 hours after surgery. Method of measurement: Note by the nurse.;Frequency of drug abuse (sedation ,headache and skin rush). Timepoint: Within 24 hours of surgery . Method of measurement: Note by the nurse.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mitra Jabalameli

Esfahan University of Medical Sciences

jabalameli@med.mui.ac.ir+98 31 1625 5555

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026