Lumbar Epidural Analgesia Versus Local Anesthesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy

Study Overview
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Brief Summary
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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
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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

Official Title
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A Comparative Study Between Lumbar Epidural Analgesia Versus Local Analgesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Drug: Dexmedetomidine Hydrochloride 'Precedex' combined with
* Procedure: Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'
* Procedure: General anesthesia
* Drug: Local infiltration with Lidocaine HCL 1%'Debocaine'


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>will receive local anesthesia with dexmedetomidine infusion | Drug: Dexmedetomidine Hydrochloride 'Precedex' combined with<br>* Dexmedetomidine Hydrochloride which is an Alfa 2 receptor agonist<br>Drug: Local infiltration with Lidocaine HCL 1%'Debocaine'<br>* Lidocaine 1% which is a local analgesic as local infiltration<br>|
| Experimental: Group B<br>will receive epidural analgesia | Procedure: Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'<br>* 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<br>|
| Experimental: Group Con<br>will receive general anesthesia | Procedure: General anesthesia<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 9 hours | 
| Postoperative anesthetic complications | Assess and compare postoperative anesthetic complications postoperative, 1 day postoperative and 2 days postoperative | 2 days | 
| Satisfaction rate of anesthesia | To compare satisfaction rate of anesthesia 1 hour postoperative Using the .The Heidelberg Peri-anaesthetic Questionnaire | 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 | 9 hours |