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The effects of epidural gelfoam soaked in bupivacaine and intramuscular paravertebral bupivacaine on postoperative analgesia after lumbar spine surgeries

Comparison of the effects of epidural gelfoam soaked in bupivacaine and intramuscular paravertebral bupivacaine on postoperative analgesia after lumbar spine surgeries

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230520058233N1
Enrollment
60
Registered
2023-07-11
Start date
2023-08-23
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Analgesia after lumbar spine surgeries.

Interventions

Intervention 1: Intervention group: For patients in the first group, a 1 × 5 cm strip of gelfoam soaked in 70 mg of 0.25% bupivacaine will be placed in the epidural space 30 minutes before wound closu

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients undergoing lumbar spine surgery with general anesthesia Age between 18 and 65 years old Patients with physical status one and two according to the criteria of the American Anesthesia Association (ASA I, II)

Exclusion criteria

Exclusion criteria: Body mass index above 30 kg/m2 History of seizure disorder Severe systemic disease Coagulation disorders Drug abusers

Design outcomes

Primary

MeasureTime frame
Pain severity. Timepoint: In recovery and 6, 12 and 24 hours after the surgery. Method of measurement: Visual analogue scale (VAS).;Time of first request for analgesic medication. Timepoint: In 24 hours after the surgery. Method of measurement: Time of request by the patient.;Dosage of morphine analgesic medication. Timepoint: In 24 hours after the surgery. Method of measurement: Miligeram.

Secondary

MeasureTime frame
Mean arterial blood pressure. Timepoint: In recovery and 6, 12 and 24 hours after the surgery. Method of measurement: Monitoring by device.;Heart rate. Timepoint: In recovery and 6, 12 and 24 hours after the surgery. Method of measurement: Monitoring by device.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Peyman Gholipour

Oroumia University of Medical Sciences

gholipour.p@umsu.ac.ir+98 44 3345 7286

Outcome results

None listed

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