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

NCT ID: NCT05850455

Last Updated: 2023-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-20
• Study Completion Date: 2023-11-30

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

Conditions

Lumbar Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

will receive local anesthesia with dexmedetomidine infusion

Group Type: EXPERIMENTAL

Dexmedetomidine Hydrochloride 'Precedex' combined with

Intervention Type: DRUG

Dexmedetomidine Hydrochloride which is an Alfa 2 receptor agonist

Local infiltration with Lidocaine HCL 1%'Debocaine'

Intervention Type: DRUG

Lidocaine 1% which is a local analgesic as local infiltration

Group B

will receive epidural analgesia

Group Type: EXPERIMENTAL

Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'

Intervention Type: PROCEDURE

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

Group Con

will receive general anesthesia

Group Type: EXPERIMENTAL

General anesthesia

Intervention Type: PROCEDURE

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

Interventions

Dexmedetomidine Hydrochloride 'Precedex' combined with

Dexmedetomidine Hydrochloride which is an Alfa 2 receptor agonist

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

General anesthesia

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: PROCEDURE

Local infiltration with Lidocaine HCL 1%'Debocaine'

Lidocaine 1% which is a local analgesic as local infiltration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

riham fathy galal

Lecturer of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine Ain shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FAMSU R 280/2022/2023

Identifier Type: -

Identifier Source: org_study_id