Steroids in posterior spinal fusion

Comparing the effects of local intraoperative epidural use of triamcinolone-soaked Gelfoam with normal saline -soaked Gelfoam on postoperative outcomes in patients undergoing posterolateral lumbar spinal fusion surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200502047277N6

Enrollment

100

Registered

2021-09-29

Start date

2021-10-01

Completion date

Unknown

Last updated

2021-11-01

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

Conditions

Fusion of spine, lumbar region. Fusion of spine, lumbar region

Interventions

Intervention 1: Intervention group: A Gelfoam soaked in 1 ml of triamcinolone acetonide (40 mg/ml, TriamHEXAL

HEXAL AG, Holzkirchen, Germany) for five minutes, will be placed placed over the nerve roots. After the placement of Gelfoam, the surgical closure will be performed. Intervention 2: Control group: Sim

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age greater than 18 years Degenerative indications for elective posterior instrumented lumbar spinal fusion surgery Written informed consent

Exclusion criteria

Exclusion criteria: Non-degenerative pathologies (e.g., tumor, trauma, deformity, or infection) Hypersensitivity reaction to the study drug American Society of Anesthesiologists (ASA) physical status> 2 Concurrent psychiatric disorder

Design outcomes

Primary

Measure	Time frame
10-point visual analog scale (VAS) for postoperative pain. Timepoint: baseline, 2, 4, 6, 12, 24, and 48 h with 1, 4, and 12 weeks postoperatively. Method of measurement: Visual analog scale.	—

Secondary

Measure	Time frame
Cumulative postoperative 24 h morphine consumption. Timepoint: 24 h postoperatively. Method of measurement: Patient-controlled analgesia device.;Oswestry disability index (ODI). Timepoint: 1 and 4 weeks postoperatively. Method of measurement: Questionnaire.;Length of stay. Timepoint: Until discharge. Method of measurement: follow-up.;Postoperative nausea and vomiting. Timepoint: Every 4 h for 24 h postoperatively. Method of measurement: follow-up and observation.;Postoperative complications. Timepoint: Once a week for 12 weeks after the surgery. Method of measurement: follow-up and observation.	—

Measure

Time frame

Cumulative postoperative 24 h morphine consumption. Timepoint: 24 h postoperatively. Method of measurement: Patient-controlled analgesia device.;Oswestry disability index (ODI). Timepoint: 1 and 4 weeks postoperatively. Method of measurement: Questionnaire.;Length of stay. Timepoint: Until discharge. Method of measurement: follow-up.;Postoperative nausea and vomiting. Timepoint: Every 4 h for 24 h postoperatively. Method of measurement: follow-up and observation.;Postoperative complications. Timepoint: Once a week for 12 weeks after the surgery. Method of measurement: follow-up and observation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoozbeh Tavanaei

Shahid Beheshti University of Medical Sciences

rtavanaei@sbmu.ac.ir+98 21 2270 1022

Outcome results

None listed

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