Skip to main content
OpenTrials
Completed

NCT Number: NCT05850455

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Ain shams University

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Dexmedetomidine Hydrochloride 'Precedex' combined with

Drug

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 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

Local infiltration with Lidocaine HCL 1%'Debocaine'

Drug

Lidocaine 1% which is a local analgesic as local infiltration

Primary outcomes

  1. Visual Analogue Scale (VAS), A score from 0 -10 where 10indicates the worst pain possible

    Time frame: 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

  2. Heart rate

    Time frame: 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

  3. Postoperative anesthetic complications

    Time frame: 2 days

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

  4. Satisfaction rate of anesthesia

    Time frame: 1 hour

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

  5. Systolic and Diastolic Blood pressure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 9, 2023
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.