Lumbar Epidural Analgesia Versus Local Anesthesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
Primary Purpose
Lumbar Disc Herniation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexmedetomidine Hydrochloride 'Precedex' combined with
Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'
General anesthesia
Local infiltration with Lidocaine HCL 1%'Debocaine'
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation
Eligibility Criteria
Inclusion Criteria: Patients American Society of anesthesiologists' physical status (ASA) I to II. Aged 18 to 50 years. Both sexes. Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group Con
Arm Description
will receive local anesthesia with dexmedetomidine infusion
will receive epidural analgesia
will receive general anesthesia
Outcomes
Primary Outcome Measures
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
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
Postoperative anesthetic complications
Assess and compare postoperative anesthetic complications postoperative, 1 day postoperative and 2 days postoperative
Satisfaction rate of anesthesia
To compare satisfaction rate of anesthesia 1 hour postoperative Using the .The Heidelberg Peri-anaesthetic Questionnaire
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05850455
Brief Title
Lumbar Epidural Analgesia Versus Local Anesthesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
Official Title
A Comparative Study Between Lumbar Epidural Analgesia Versus Local Analgesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
will receive local anesthesia with dexmedetomidine infusion
Arm Title
Group B
Arm Type
Experimental
Arm Description
will receive epidural analgesia
Arm Title
Group Con
Arm Type
Experimental
Arm Description
will receive general anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride 'Precedex' combined with
Intervention Description
Dexmedetomidine Hydrochloride which is an Alfa 2 receptor agonist
Intervention Type
Procedure
Intervention Name(s)
Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Local infiltration with Lidocaine HCL 1%'Debocaine'
Intervention Description
Lidocaine 1% which is a local analgesic as local infiltration
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS), A score from 0 -10 where 10indicates the worst pain possible
Description
The first outcome is to compare the VAS preoperative, intraoperative for group A, B and 1 hour postoperative for group A, B and Con
Time Frame
4 hours
Title
Heart rate
Description
Comparing the Heart rate ( Heart beats per minute) for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours
Time Frame
9 hours
Title
Postoperative anesthetic complications
Description
Assess and compare postoperative anesthetic complications postoperative, 1 day postoperative and 2 days postoperative
Time Frame
2 days
Title
Satisfaction rate of anesthesia
Description
To compare satisfaction rate of anesthesia 1 hour postoperative Using the .The Heidelberg Peri-anaesthetic Questionnaire
Time Frame
1 hour
Title
Systolic and Diastolic Blood pressure
Description
Comparing the systolic and diastolic Blood Pressure in mmHG for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours
Time Frame
9 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients American Society of anesthesiologists' physical status (ASA) I to II.
Aged 18 to 50 years.
Both sexes.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riham Fa Galal, MD
Phone
01022739211
Ext
+2
Email
Rihamfathygalal@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lumbar Epidural Analgesia Versus Local Anesthesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
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