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Studying the effect of bupivacaine with bupivacaine-ondansetron combination in lumbar surgery pain

Comparison of the preventive effect of bupivacaine infiltration with bupivacaine-ondansetron combination on pain relief after lumbar fusion surgery and recovery complications.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260206068773N1
Enrollment
90
Registered
2026-04-19
Start date
2026-04-21
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Pain after lumbar disc surgery. Other acute postprocedural pain

Interventions

Intervention 1: Intervention Group 1: At the end of surgery, after fascial closure and achieving hemostasis, and under sterile conditions, infiltration was performed with 8 mL of 0.25% bupivacaine sol

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients 45 to 65 years old Patients undergoing lumbar fusion surgery American society of anesthesiologists (ASA) physical status classification 1,2

Exclusion criteria

Exclusion criteria: Addiction Hypersensitivity to bupivacaine or other local anesthetics or ondansetron Previous spinal surgery History of seizure

Design outcomes

Primary

MeasureTime frame
Mean arterial pressure. Timepoint: Every 10 minutes from the start of surgery for 2 hours. Method of measurement: Digital blood pressure monitor.;Pain severity based on the Visual Analog Scale (VAS). Timepoint: Every 10 minutes in recovery up to 120 minutes. Method of measurement: Visual analog scale.;Agitation score based on the Riker Sedation-Agitation Scale. Timepoint: Every 10 minutes in recovery up to 120 minutes. Method of measurement: Riker Sedation-Agitation Scale.;Systolic blood pressure. Timepoint: Every 10 minutes from the start of surgery for 2 hours. Method of measurement: Digital blood pressure monitor.;Diastolic blood pressure. Timepoint: Every 10 minutes from the start of surgery for 2 hours. Method of measurement: Digital blood pressure monitor.;Heart rate. Timepoint: Every 10 minutes from the start of surgery for 2 hours. Method of measurement: Pulse oximeter.;Blood oxygen saturation percentage. Timepoint: Every 10 minutes from the start of surgery for 2 hours. Method of measurement: Pulse oximeter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mehrdad Masoudifar

Esfahan University of Medical Sciences

masoudifar@med.mui.ac.ir+98 938 185 4398

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026