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Completed

NCT Number: NCT07088016

A Comparative Study Between Lumbar Epidural Analgesia Versus Local Infiltration Anesthesia Combined With Dexmedetomidine Intravenous Infusion in Endoscopic Lumbar Discectomy Surgeries: A Retrospective Study

The goal of this observational study is to compare the effectiveness and patient satisfaction of local anesthesia combined with intravenous Dexmedetomidine versus epidural anesthesia in endoscopic lumbar discectomy surgeries

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

International Medical Center

Cairo, Egypt

About this study

In recent years, with the development of medical instruments, minimally invasive surgical methods for lumbar disc herniation became increasingly popular, such as percutaneous transforaminal endoscopic discectomy (PTED) PTED under local anesthesia (LA) is recommended in consideration of safety. Under LA, patients keep conscious during the procedure, and the surgeon can obtain feedback directly from the patients if the nerve is interfered. However, in clinical practice, we found that many patients couldn't tolerate the pain during operation especially when placing the working channel Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing sedation and analgesia. Due to its central sympatholytic action, DEX produces dose-dependent sedation, antinociception and anxiolysis, while decreasing intraoperative hypertension and tachycardia episodes 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 60 years.
  • Both sexes.
  • Patients with clinical and radiological evidence of soft disc herniation in a single lumber segment.

Exclusion criteria

  • Spinal malformation
  • Recurrent lumber disc herniation (LDH)
  • Multi segment LDH
  • Patients younger than 18 years or older than 60 years
  • Patients with hypersensitivity to one of the used drugs
  • Patients suffering of coagulopathy
  • Operation time more than 1 hour

Treatment and study plan

Primary outcomes

  1. we compare numerical rating pain score (NRS) between the two groups immediately at foraminal dilatation maneuver

    Time frame: from January 2021 to January 2024

    It refers to the common method used in healthcare where patients rate their pain on a scale from 0 to 10:

    0 = No pain 10 = Worst pain imaginable.

Secondary outcomes

  1. Heart rate (H.R)

    Time frame: from January 2021 to January 2024

    We compare the heart rate ( by beats per minute) in the 2 groups every 10 minutes intraoperative

  2. Mean arterial blood pressure (MABP)

    Time frame: from January 2021 to January 2024

    we compare mean arterial blood pressure between the 2 groups by millimeter of mercury (mmhg) every 10 minutes intraoperative

  3. we compare Bromage scale in the two groups intraoperative during foraminal dilatation by the surgeon

    Time frame: from January 2021 to January 2024

    It is a clinical tool used to assess motor function in the lower limbs following epidural or spinal anesthesia (from 0 to 3) 0 means full movement (no motor blockage) 3 means complete motor block - unable to move feet, legs, or raise leg.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Egyptian Center for Research and Regenerative Medicine

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

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.

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