Skip to content

Effect of B complex in analgesia of orthopedic patients

Preventive analgesic effect of vitamin B complex in combination with fentanyl in patients undergoing fixation surgery for lower leg fractures

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250421065424N1
Enrollment
40
Registered
2025-09-08
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Condition 1: Tibial Fracture. Condition 2: Postoperative Pain. Condition 3: Pain Prevention. Unspecified fracture of shaft of right tibia, initial encounter for closed fracture Other acute postprocedural pain Pain, unspecified

Interventions

Intervention 1: Intervention group: Patients in this group receive an intramuscular injection of vitamin B complex (BECOVIT 2ml ampoule) prior to the start of surgery.The ampoule contains: 4 mg vitami

Sponsors

Bandare-abbas University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 65 with ASA I-II, who were candidates for elective orthopedic surgery for fracture fixation of the tibia, were included.

Exclusion criteria

Exclusion criteria: emergency cases those allergic to vitamin B complex those with a history of analgesic use drug addicts patients with cardiac/hepatic/renal failure hemodynamically unstable patients those with multiple fractures

Design outcomes

Primary

MeasureTime frame
Pain intensity in patients undergoing lower limb fracture fixation surgery at 1, 6, 12, and 24 hours postoperatively, measured using the Visual Analogue Scale. Timepoint: At 1, 6, 12, and 24 hours after the end of surgery. Method of measurement: Visual Analogue Scale (VAS) ranging from 0 to 10.;Requirement for specific analgesic medication (pethidine) in patients undergoing lower limb fracture fixation surgery at 1, 6, 12, and 24 hours postoperatively. Timepoint: At 1, 6, 12, and 24 hours after the end of surgery. Method of measurement: Documentation of intravenous administration of 25 mg pethidine when pain intensity exceeds 3 on the Visual Analogue Scale, recorded by an anesthesiology staff member.

Secondary

MeasureTime frame
Systolic blood pressure in patients undergoing lower limb fracture fixation surgery during recovery (at 0, 15, 30, and 60 minutes postoperatively). Timepoint: At 0, 15, 30, and 60 minutes after the end of surgery in the recovery room. Method of measurement: Measurement of systolic blood pressure using non-invasive blood pressure monitor (NIBP) via operating room monitoring system.;Heart rate in patients undergoing lower limb fracture fixation surgery during recovery (at 0, 15, 30, and 60 minutes postoperatively). Timepoint: At 0, 15, 30, and 60 minutes after the end of surgery in the recovery room. Method of measurement: Measurement of heart rate using electrocardiogram (ECG) monitoring in the operating room.;Diastolic blood pressure in patients undergoing lower limb fracture fixation surgery during recovery (at 0, 15, 30, and 60 minutes postoperatively). Timepoint: At 0, 15, 30, and 60 minutes after the end of surgery in the recovery room. Method of measurement: Measurement of diastolic blood pressure using non-invasive blood pressure monitor (NIBP) via operating room monitoring system.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Jamalizadeh

Bandare-abbas University of Medical Sciences

fjamali351@gmail.com+98 76 3367 0000

Outcome results

None listed

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