Lumbar Disc HerniationNCT05850455
Lumbar Epidural Analgesia Versus Local Anesthesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
A study testing Dexmedetomidine Hydrochloride 'Precedex' combined with, Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine' and General anesthesia in people with Lumbar Disc Herniation, run by Ain Shams University at 1 site in Egypt.
Trial summary
To compare between local anesthesia combined with intravenous Dexmedetomidine and epidural analgesia as regard the effectiveness and patient satisfaction during percutaneous transforaminal endoscopic discectomy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Dexmedetomidine Hydrochloride 'Precedex' combined with, Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine' and General anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2023to 30 Nov 2023
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients American Society of anesthesiologists' physical status (ASA) I to II.
- Aged 18 to 50 years.
- Both sexes.
Who cannot join
- Spinal malformation
- Recurrent LDH
- Multi segment LDH
- Patients younger than 18 years or older than 50 years
- Patients with hypersensitivity to one of the used drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Lumbar Epidural Analgesia Versus Local Analgesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
To compare between local anesthesia combined with intravenous Dexmedetomidine and epidural analgesia as regard the effectiveness and patient satisfaction during percutaneous transforaminal endoscopic discectomy.
Read the detailed description
Percutaneous transforaminal endoscopic discectomy. under LA is recommended in consideration of safety. Under LA, patients keep conscious during the process of PTED, and the surgeon can obtain feedback directly from the patients if the nerve is interfered. Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing sedation and analgesia. Due to its central sympatholytic action, Dexmedetomidine produces dose-dependent sedation, antinociception and anxiolysis. 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
- Lumbar Disc Herniation
- Being tested
- Dexmedetomidine Hydrochloride 'Precedex' combined with, Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine', General anesthesia, Local infiltration with Lidocaine HCL 1%'Debocaine'
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Hydrochloride 'Precedex' combined withDrug
Dexmedetomidine Hydrochloride which is an Alfa 2 receptor agonist
Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'Procedure or surgery
The epidural insertion point will be 2 segments upper than the surgical procedure level, 10 ml of Bupivacaine 0.25% will be injected in the epidural space to adjust the sensory level
General anesthesiaProcedure or surgery
Propofol 2-3 mg/kg'Diprivan 1%', Fentanyl 'Fentanyl' 2 μg/kg, and Cisatracurium 'Cisatracure' 0.2 mg/kg will be administered to facilitate endotracheal intubation, and ventilation will be controlled to maintain the end-tidal carbon dioxide (CO2) between 32-38 mmHg, to maintain anesthesia, 2-3% Sevoflurane 'Sevoflurane', and 0.05 mg/kg of the muscle relaxant Cisatracurium will be added at 40-minute intervals according to the conditions of the operation. No other medication will be administered
Local infiltration with Lidocaine HCL 1%'Debocaine'Drug
Lidocaine 1% which is a local analgesic as local infiltration
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | will receive local anesthesia with dexmedetomidine infusion Receives: Drug: Dexmedetomidine Hydrochloride 'Precedex' combined with; Drug: Local infiltration with Lidocaine HCL 1%'Debocaine' |
| Group B | Experimental | will receive epidural analgesia Receives: Procedure: Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine' |
| Group Con | Experimental | will receive general anesthesia Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS), A score from 0 -10 where 10indicates the worst pain possible
The first outcome is to compare the VAS preoperative, intraoperative for group A, B and 1 hour postoperative for group A, B and Con
Measured: 4 hours
Heart rate
Comparing the Heart rate ( Heart beats per minute) for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours
Measured: 9 hours
Postoperative anesthetic complications
Assess and compare postoperative anesthetic complications postoperative, 1 day postoperative and 2 days postoperative
Measured: 2 days
Satisfaction rate of anesthesia
To compare satisfaction rate of anesthesia 1 hour postoperative Using the .The Heidelberg Peri-anaesthetic Questionnaire
Measured: 1 hour
Systolic and Diastolic Blood pressure
Comparing the systolic and diastolic Blood Pressure in mmHG for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours
Measured: 9 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start20 May 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, riham fathy galal, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850455
- Sponsor's protocol ID
- FAMSU R 280/2022/2023
- Status last verified
- Dec 2023
- First submitted
- 19 Apr 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Lumbar Epidural Analgesia Versus Local Analgesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
- ClinicalTrials.gov ID
- NCT05850455
- Acronym / sponsor ID
- FAMSU R 280/2022/2023
- Conditions
- Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 9 May 2023 (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.
To compare between local anesthesia combined with intravenous Dexmedetomidine and epidural analgesia as regard the effectiveness and patient satisfaction during percutaneous transforaminal endoscopic discectomy.
Detailed description
Percutaneous transforaminal endoscopic discectomy. under LA is recommended in consideration of safety. Under LA, patients keep conscious during the process of PTED, and the surgeon can obtain feedback directly from the patients if the nerve is interfered. Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing sedation and analgesia. Due to its central sympatholytic action, Dexmedetomidine produces dose-dependent sedation, antinociception and anxiolysis. 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Dexmedetomidine Hydrochloride 'Precedex' combined with, Drug: Local infiltration with Lidocaine HCL 1%'Debocaine'will receive local anesthesia with dexmedetomidine infusion |
| Group B | Experimental | Procedure: Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'will receive epidural analgesia |
| Group Con | Experimental | Procedure: General anesthesiawill receive general anesthesia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients American Society of anesthesiologists' physical status (ASA) I to II.
- Aged 18 to 50 years.
- Both sexes.
Key exclusion criteria (5 listed)
- Spinal malformation
- Recurrent LDH
- Multi segment LDH
- Patients younger than 18 years or older than 50 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine Hydrochloride 'Precedex' combined withDexmedetomidine Hydrochloride which is an Alfa 2 receptor agonist | Drug | Group A |
| Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'The epidural insertion point will be 2 segments upper than the surgical procedure level, 10 ml of Bupivacaine 0.25% will be injected in the epidural space to adjust the sensory level | Procedure or surgery | Group B |
| General anesthesiaPropofol 2-3 mg/kg'Diprivan 1%', Fentanyl 'Fentanyl' 2 μg/kg, and Cisatracurium 'Cisatracure' 0.2 mg/kg will be administered to facilitate endotracheal intubation, and ventilation will be controlled to maintain the end-tidal carbon dioxide (CO2) between 32-38 mmHg, to maintain anesthesia, 2-3% Sevoflurane 'Sevoflurane', and 0.05 mg/kg of the muscle relaxant Cisatracurium will be added at 40-minute intervals according to the conditions of the operation. No other medication will be administered | Procedure or surgery | Group Con |
| Local infiltration with Lidocaine HCL 1%'Debocaine'Lidocaine 1% which is a local analgesic as local infiltration | Drug | Group A |
Primary outcome
Visual Analogue Scale (VAS), A score from 0 -10 where 10indicates the worst pain possible
Time frame: 4 hours
The first outcome is to compare the VAS preoperative, intraoperative for group A, B and 1 hour postoperative for group A, B and Con
Heart rate
Time frame: 9 hours
Comparing the Heart rate ( Heart beats per minute) for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours
Postoperative anesthetic complications
Time frame: 2 days
Assess and compare postoperative anesthetic complications postoperative, 1 day postoperative and 2 days postoperative
Satisfaction rate of anesthesia
Time frame: 1 hour
To compare satisfaction rate of anesthesia 1 hour postoperative Using the .The Heidelberg Peri-anaesthetic Questionnaire
Systolic and Diastolic Blood pressure
Time frame: 9 hours
Comparing the systolic and diastolic Blood Pressure in mmHG for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours
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 6 Dec 2023.
- 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 Dexmedetomidine Hydrochloride 'Precedex' combined with, Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine' and General anesthesia in people with Lumbar Disc Herniation, 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 3 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 6 Dec 2023. 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?
Visual Analogue Scale (VAS), A score from 0 -10 where 10indicates the worst pain possible (time frame: 4 hours). The study lists 5 primary outcomes in all. 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 6 Dec 2023.