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Clinical Trials/NCT07088016
NCT07088016CompletedNot Applicable

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

Ain Shams University1 site in 1 country100 target enrollmentStarted: January 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
we compare numerical rating pain score (NRS) between the two groups immediately at foraminal dilatation maneuver

Study Overview

Brief Summary

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

Detailed Description

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

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Heart rate (H.R)(from January 2021 to January 2024)
  • Mean arterial blood pressure (MABP)(from January 2021 to January 2024)
  • we compare Bromage scale in the two groups intraoperative during foraminal dilatation by the surgeon(from January 2021 to January 2024)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maha Salah

Dr

Egyptian Center for Research and Regenerative Medicine

Study Sites (1)

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