NCT06898697

Brief Summary

The purpose of this study is to compare better postoperative analgesia after lumbar spine Fixation using either epidural bupivacaine with midazolam or fentanyl with the combination of dexamethasone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

March 13, 2025

Last Update Submit

January 19, 2026

Conditions

Lumbar Spine Fixation

Outcome Measures

Primary Outcomes (1)

  • the time to first call to rescue analgesia (ketorolac)

    day 1

Secondary Outcomes (3)

  • The Numerical Pain Rating Scale

    24 hours postoperative]

  • The total postoperative opioid consumption in the first 24 hours. opioid consumption

    24 hours postoperative

  • the duration of hospital stay

    up to 1 week

Study Arms (2)

fentanyl

ACTIVE COMPARATOR

Patients will receive 10 ml of bupivacaine 0. 25 % plus 100µg fentanyl in 2ml plus 2ml (8mg) dexamethasone (14 ml total volume).

Drug: Epidural fentanyl

midazolam

ACTIVE COMPARATOR

Patients will receive 10 ml of bupivacaine 0.25 % plus 2mg midazolam in 2ml plus 2 ml (8mg) dexamethasone with (14 ml total volume).

Drug: epidural midazolam

Interventions

Epidural fentanylDRUG

Fentanyl will be injected in the epidural space by the surgeon one or two levels above the surgical site.

fentanyl
epidural midazolamDRUG

midazolam will be injected in the epidural space by the surgeon one or two levels above the surgical site.

midazolam

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent from the patient.
  • Physical status: ASA 1\& II.
  • BMI = (25-30 kg/m2).
  • Type of operation: elective lumbar spine Fixation.

You may not qualify if:

  • Altered mental state.
  • Patients with known history of allergy to study drugs.
  • Advanced hepatic, renal, cardiovascular, and respiratory diseases.
  • Patients with chronic pain.
  • Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine,Zagazig University

Zagazig, 44519, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of anesthesia and surgical intensive care (Principal Investigator)

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 27, 2025

Study Start

April 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)