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

Not Applicable

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: 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'

• Registration Number: NCT05850455
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-04-29
• Study First Posted: 2023-05-09
• Study Start: 2023-05-20
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Patients American Society of anesthesiologists' physical status (ASA) I to II.
2. Aged 18 to 50 years.
3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Dexmedetomidine Hydrochloride 'Precedex' combined with	will receive local anesthesia with dexmedetomidine infusion
Group B	Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'	will receive epidural analgesia
Group Con	General anesthesia	will receive general anesthesia
Group A	Local infiltration with Lidocaine HCL 1%'Debocaine'	will receive local anesthesia with dexmedetomidine infusion

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS), A score from 0 -10 where 10indicates the worst pain possible	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	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
Satisfaction rate of anesthesia	1 hour	To compare satisfaction rate of anesthesia 1 hour postoperative Using the .The Heidelberg Peri-anaesthetic Questionnaire
Systolic and Diastolic Blood pressure	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
Postoperative anesthetic complications	2 days	Assess and compare postoperative anesthetic complications postoperative, 1 day postoperative and 2 days postoperative

Trial Locations

Locations (1)

Faculty of Medicine Ain shams University; 🇪🇬 Cairo, Egypt