Epidural Analgesics for ComparisonNCT07088016
A Comparative Study Between Lumbar Epidural Analgesia Versus Local Infiltration Anesthesia Combined With Dexmedetomidine Intravenous Infusion in Endoscopic Lumbar Discectomy Surgeries: A Retrospective Study
An observational study of Epidural Analgesics for Comparison, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this observational study is to compare the effectiveness and patient satisfaction of local anesthesia combined with intravenous Dexmedetomidine versus epidural anesthesia in endoscopic lumbar discectomy surgeries Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epidural Analgesics for Comparison
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Jan 2024
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients are American Society of anesthesiologists' physical status (ASA) I to II aged 18 to 60 years of both sexes with clinical and radiological evidence of soft disc herniation in a single lumber segment.
Who may be able to join
- Patients American Society of anesthesiologists' physical status (ASA) I to II.
- Aged 18 to 60 years.
- Both sexes.
- Patients with clinical and radiological evidence of soft disc herniation in a single lumber segment.
Who cannot join
- Spinal malformation
- Recurrent lumber disc herniation (LDH)
- Multi segment LDH
- Patients younger than 18 years or older than 60 years
- Patients with hypersensitivity to one of the used drugs
- Patients suffering of coagulopathy
- Operation time more than 1 hour
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to compare the effectiveness and patient satisfaction of local anesthesia combined with intravenous Dexmedetomidine versus epidural anesthesia in endoscopic lumbar discectomy surgeries
Read the detailed description
In recent years, with the development of medical instruments, minimally invasive surgical methods for lumbar disc herniation became increasingly popular, such as percutaneous transforaminal endoscopic discectomy (PTED) PTED under local anesthesia (LA) is recommended in consideration of safety. Under LA, patients keep conscious during the procedure, and the surgeon can obtain feedback directly from the patients if the nerve is interfered. However, in clinical practice, we found that many patients couldn't tolerate the pain during operation especially when placing the working channel Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing sedation and analgesia. Due to its central sympatholytic action, DEX produces dose-dependent sedation, antinociception and anxiolysis, while decreasing intraoperative hypertension and tachycardia episodes Epidural anesthesia is another major method which can keep patients awake during surgery and the surgeons can check the function of the nerve from the maintained motor function of patients' lower limbs
- Conditions
- Epidural Analgesics for Comparison
- Keywords
- epidural, dexmedetomidine, microscopic lumber discectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine group | loading of Dexmedetomidine was done at a dose of 1 mcg/ kg over 10 minutes followed by continuous infusion at a rate of 0.5 mcg/kg/hr , followed by infiltration of the skin with 2-3 ml of lidocaine hydrochloride 1 % first by the surgeon then an 18 -G needle will be introduced to anesthetize the trajectory with 8-10 ml lidocaine 1 %. After reaching the superior articular process, 2-3 ml of lidocaine 1 % was used to anesthetize the facet joint. | |
| Epidural group | The epidural insertion point was 2 segments upper than the surgical procedure, 10 ml of Bupivacaine 0.25% was injected in the epidural space to adjust the sensory level. The epidural catheter will be removed after 2 hours from the end of the operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
we compare numerical rating pain score (NRS) between the two groups immediately at foraminal dilatation maneuver
It refers to the common method used in healthcare where patients rate their pain on a scale from 0 to 10:
0 = No pain 10 = Worst pain imaginable.
Measured: from January 2021 to January 2024
Secondary outcomes (3)
Heart rate (H.R)
We compare the heart rate ( by beats per minute) in the 2 groups every 10 minutes intraoperative
Measured: from January 2021 to January 2024
Mean arterial blood pressure (MABP)
we compare mean arterial blood pressure between the 2 groups by millimeter of mercury (mmhg) every 10 minutes intraoperative
Measured: from January 2021 to January 2024
we compare Bromage scale in the two groups intraoperative during foraminal dilatation by the surgeon
It is a clinical tool used to assess motor function in the lower limbs following epidural or spinal anesthesia (from 0 to 3) 0 means full movement (no motor blockage) 3 means complete motor block - unable to move feet, legs, or raise leg.
Measured: from January 2021 to January 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Jan 2021
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural Analgesics for ComparisonStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Egyptian Center for Research and Regenerative Medicine
- Responsible party
- Principal investigator, Maha Salah, Egyptian Center for Research and Regenerative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088016
- Sponsor's protocol ID
- 6/02-2025
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "IPD will not be shared due to concerns regarding participant privacy, confidentiality, and regulatory limitations. In addition, appropriate consent for data sharing may not have been obtained from participants at the time of enrollment
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Lumbar Epidural Analgesia Versus Local Infiltration Anesthesia Combined With Dexmedetomidine Intravenous Infusion in Endoscopic Lumbar Discectomy Surgeries: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07088016
- Acronym / sponsor ID
- 6/02-2025
- Conditions
- Epidural Analgesics for Comparison
- Keywords
- epidural, dexmedetomidine, microscopic lumber discectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Egyptian Center for Research and Regenerative Medicine
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 28 Jul 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 goal of this observational study is to compare the effectiveness and patient satisfaction of local anesthesia combined with intravenous Dexmedetomidine versus epidural anesthesia in endoscopic lumbar discectomy surgeries
Detailed description
In recent years, with the development of medical instruments, minimally invasive surgical methods for lumbar disc herniation became increasingly popular, such as percutaneous transforaminal endoscopic discectomy (PTED) PTED under local anesthesia (LA) is recommended in consideration of safety. Under LA, patients keep conscious during the procedure, and the surgeon can obtain feedback directly from the patients if the nerve is interfered. However, in clinical practice, we found that many patients couldn't tolerate the pain during operation especially when placing the working channel Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing sedation and analgesia. Due to its central sympatholytic action, DEX produces dose-dependent sedation, antinociception and anxiolysis, while decreasing intraoperative hypertension and tachycardia episodes Epidural anesthesia is another major method which can keep patients awake during surgery and the surgeons can check the function of the nerve from the maintained motor function of patients' lower limbs
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine group | – | –loading of Dexmedetomidine was done at a dose of 1 mcg/ kg over 10 minutes followed by continuous infusion at a rate of 0.5 mcg/kg/hr , followed by infiltration of the skin with 2-3 ml of lidocaine hydrochloride 1 % first by the surgeon then an 18 -G needle will be introduced to anesthetize the trajectory with 8-10 ml lidocaine 1 %. After reaching the superior articular process, 2-3 ml of lidocaine 1 % was used to anesthetize the facet joint. |
| Epidural group | – | –The epidural insertion point was 2 segments upper than the surgical procedure, 10 ml of Bupivacaine 0.25% was injected in the epidural space to adjust the sensory level. The epidural catheter will be removed after 2 hours from the end of the operation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients are American Society of anesthesiologists' physical status (ASA) I to II aged 18 to 60 years of both sexes with clinical and radiological evidence of soft disc herniation in a single lumber segment.
Key inclusion criteria (4 listed)
- Patients American Society of anesthesiologists' physical status (ASA) I to II.
- Aged 18 to 60 years.
- Both sexes.
- Patients with clinical and radiological evidence of soft disc herniation in a single lumber segment.
Key exclusion criteria (7 listed)
- Spinal malformation
- Recurrent lumber disc herniation (LDH)
- Multi segment LDH
- Patients younger than 18 years or older than 60 years
- Patients with hypersensitivity to one of the used drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
we compare numerical rating pain score (NRS) between the two groups immediately at foraminal dilatation maneuver
Time frame: from January 2021 to January 2024
It refers to the common method used in healthcare where patients rate their pain on a scale from 0 to 10: 0 = No pain 10 = Worst pain imaginable.
3 secondary outcomes
Heart rate (H.R)
Time frame: from January 2021 to January 2024
Mean arterial blood pressure (MABP)
Time frame: from January 2021 to January 2024
we compare Bromage scale in the two groups intraoperative during foraminal dilatation by the surgeon
Time frame: from January 2021 to January 2024
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 28 Jul 2025.
- Individual participant dataSharing planned: No. "IPD will not be shared due to concerns regarding participant privacy, confidentiality, and regulatory limitations. In addition, appropriate consent for data sharing may not have been obtained from participants at the time of enrollment
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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?
An observational study of Epidural Analgesics for Comparison, run by Ain Shams 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 7 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 28 Jul 2025. 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?
we compare numerical rating pain score (NRS) between the two groups immediately at foraminal dilatation maneuver (time frame: from January 2021 to January 2024). 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 28 Jul 2025.