Lumbar Spine FixationNCT06898697
Fentanyl as Adjuvants to Epidural Bupivacaine Plus Dexamethasone for Analgesia
A study testing postoperative analgesia and epidural fentanyl in people with Lumbar Spine Fixation, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Lumbar Spine Fixation
- What is being tested?
- postoperative analgesia and epidural fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent from the patient.
- Physical status: ASA 1\& II.
- BMI = (25-30 kg/m2).
- Type of operation: elective lumbar spine Fixation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fentanyl as Adjuvants to Epidural Bupivacaine Plus Dexamethasone for Analgesia After Lumbar Spine Fixation: A Randomized Clinical Study
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.
Read the detailed description
After being informed about the study and potential risks. A computer-generated randomization table will randomize all patients giving written consent into 2 groups, each containing 51 patients. In the Fentanyl Group :.Patients will receive 10 ml of bupivacaine 0. 25 % plus 100µg fentanyl in 2ml plus 2ml (8mg) dexamethasone.In Midazolam Group: Patients will receive 10 ml of bupivacaine 0.25 % plus 2mg midazolam in 2ml plus 2 ml (8mg) dexamethasone
- Conditions
- Lumbar Spine Fixation
- Being tested
- postoperative analgesia, epidural fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative analgesiaDrug
postoperative analgesia
epidural fentanylDrug
fentanyl will be injected in the epidural space by the surgeon one or two levels above the surgical site.
| Study group | Role | What they receive |
|---|---|---|
| fentanyl | Active comparator | Patients will receive 10 ml of bupivacaine 0.25 % plus 100 mic fentanyl in 2ml plus 2 ml (8mg) dexamethasone with (14 ml total volume). Receives: Drug: epidural fentanyl |
| control | Other | postoperative analgesia Receives: Drug: postoperative analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to first call to rescue analgesia (ketorolac)
Measured: day 1
Secondary outcomes (3)
The Numerical Pain Rating Scale
A ten-centimeter Numerical Pain Rating Scale (0 - no pain and 10 - worst pain)
Measured: 24 hours postoperative]
The total postoperative opioid consumption in the first 24 hours. opioid consumption
Measured: 24 hours postoperative
the duration of hospital stay
from the post operative day till discharge from hospital.
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Apr 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine FixationStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mohamed Medhat, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898697
- Sponsor's protocol ID
- ZU-IRB#1075/ 25-Feb-2025
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl as Adjuvants to Epidural Bupivacaine Plus Dexamethasone for Analgesia After Lumbar Spine Fixation: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06898697
- Acronym / sponsor ID
- ZU-IRB#1075/ 25-Feb-2025
- Conditions
- Lumbar Spine Fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After being informed about the study and potential risks. A computer-generated randomization table will randomize all patients giving written consent into 2 groups, each containing 51 patients. In the Fentanyl Group :.Patients will receive 10 ml of bupivacaine 0. 25 % plus 100µg fentanyl in 2ml plus 2ml (8mg) dexamethasone.In Midazolam Group: Patients will receive 10 ml of bupivacaine 0.25 % plus 2mg midazolam in 2ml plus 2 ml (8mg) dexamethasone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fentanyl | Active comparator | Drug: epidural fentanylPatients will receive 10 ml of bupivacaine 0.25 % plus 100 mic fentanyl in 2ml plus 2 ml (8mg) dexamethasone with (14 ml total volume). |
| control | Other | Drug: postoperative analgesiapostoperative analgesia |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Written informed consent from the patient.
- Physical status: ASA 1\& II.
- BMI = (25-30 kg/m2).
- Type of operation: elective lumbar spine Fixation.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postoperative analgesiapostoperative analgesia | Drug | control |
| epidural fentanylfentanyl will be injected in the epidural space by the surgeon one or two levels above the surgical site. | Drug | fentanyl |
Primary outcome
the time to first call to rescue analgesia (ketorolac)
Time frame: day 1
3 secondary outcomes
The Numerical Pain Rating Scale
Time frame: 24 hours postoperative]
The total postoperative opioid consumption in the first 24 hours. opioid consumption
Time frame: 24 hours postoperative
the duration of hospital stay
Time frame: up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postoperative analgesia and epidural fentanyl in people with Lumbar Spine Fixation, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time to first call to rescue analgesia (ketorolac) (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.