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

NCT05850455 | Completed

• 1 other identifier: FAMSU R 280/2022/2023
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Group A

EXPERIMENTAL

will receive local anesthesia with dexmedetomidine infusion

Drug: Dexmedetomidine Hydrochloride 'Precedex' combined with; Drug: Local infiltration with Lidocaine HCL 1%'Debocaine'

Group B

EXPERIMENTAL

will receive epidural analgesia

Procedure: Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'

Group Con

EXPERIMENTAL

will receive general anesthesia

Procedure: General anesthesia

Interventions

Dexmedetomidine Hydrochloride 'Precedex' combined with DRUG

Dexmedetomidine Hydrochloride which is an Alfa 2 receptor agonist

Group A

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

Group B

General anesthesia 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

Group Con

Local infiltration with Lidocaine HCL 1%'Debocaine' DRUG

Lidocaine 1% which is a local analgesic as local infiltration

Group A

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients American Society of anesthesiologists' physical status (ASA) I to II.
• Aged 18 to 50 years.
• Both sexes.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine Ain shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Bupivacaine; Anesthesia, General

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 9, 2023
• Study Start: May 20, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)