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

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05850455
• Other study ID #: FAMSU R 280/2022/2023
• Status: Completed
• Phase: N/A
• Start date: May 20, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Drug:
• Dexmedetomidine Hydrochloride 'Precedex' combined with
Dexmedetomidine Hydrochloride which is an Alfa 2 receptor agonist

Procedure:
• 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
• 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

Drug:
• Local infiltration with Lidocaine HCL 1%'Debocaine'
Lidocaine 1% which is a local analgesic as local infiltration

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Ain shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Postoperative anesthetic complications	Assess and compare postoperative anesthetic complications postoperative, 1 day postoperative and 2 days postoperative	2 days
Primary	Satisfaction rate of anesthesia	To compare satisfaction rate of anesthesia 1 hour postoperative Using the .The Heidelberg Peri-anaesthetic Questionnaire	1 hour
Primary	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