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

Ain Shams University78 enrolled

Overview

To compare between local anesthesia combined with intravenous Dexmedetomidine and epidural analgesia as regard the effectiveness and patient satisfaction during percutaneous transforaminal endoscopic discectomy.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lumbar Disc Herniation

Interventions

Dexmedetomidine Hydrochloride 'Precedex' combined withDRUG

Dexmedetomidine Hydrochloride which is an Alfa 2 receptor agonist

Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'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

General anesthesiaPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine Ain shams University

Cairo, Egypt

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 9 hours

Postoperative anesthetic complications

Assess and compare postoperative anesthetic complications postoperative, 1 day postoperative and 2 days postoperative

Time frame: 2 days

Satisfaction rate of anesthesia

To compare satisfaction rate of anesthesia 1 hour postoperative Using the .The Heidelberg Peri-anaesthetic Questionnaire

Time frame: 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

Time frame: 9 hours

Data from ClinicalTrials.gov

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