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

A

Ain Shams University

Status

Completed

Conditions

Lumbar Disc Herniation

Treatments

Procedure: Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'
Drug: Local infiltration with Lidocaine HCL 1%'Debocaine'
Drug: Dexmedetomidine Hydrochloride 'Precedex' combined with
Procedure: General anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT05850455
FAMSU R 280/2022/2023

Details and patient eligibility

About

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

Full 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

Enrollment

78 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

78 participants in 3 patient groups

Group A
Experimental group
Description:
will receive local anesthesia with dexmedetomidine infusion
Treatment:
Drug: Dexmedetomidine Hydrochloride 'Precedex' combined with
Drug: Local infiltration with Lidocaine HCL 1%'Debocaine'
Group B
Experimental group
Description:
will receive epidural analgesia
Treatment:
Procedure: Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'
Group Con
Experimental group
Description:
will receive general anesthesia
Treatment:
Procedure: General anesthesia

Trial contacts and locations

1

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Central trial contact

Riham Fa Galal, MD

Data sourced from clinicaltrials.gov

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