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

NCT ID: NCT07088016

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-01-01

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

Conditions

Epidural Analgesics for Comparison

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

dexmedetomidine group

loading of Dexmedetomidine was done at a dose of 1 mcg/ kg over 10 minutes followed by continuous infusion at a rate of 0.5 mcg/kg/hr , followed by infiltration of the skin with 2-3 ml of lidocaine hydrochloride 1 % first by the surgeon then an 18 -G needle will be introduced to anesthetize the trajectory with 8-10 ml lidocaine 1 %. After reaching the superior articular process, 2-3 ml of lidocaine 1 % was used to anesthetize the facet joint.

No interventions assigned to this group

Epidural group

The epidural insertion point was 2 segments upper than the surgical procedure, 10 ml of Bupivacaine 0.25% was injected in the epidural space to adjust the sensory level. The epidural catheter will be removed after 2 hours from the end of the operation

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Patients American Society of anesthesiologists' physical status (ASA) I to II.

2. Aged 18 to 60 years.

3. Both sexes.

4. Patients with clinical and radiological evidence of soft disc herniation in a single lumber segment.

Exclusion Criteria

1. Spinal malformation

2. Recurrent lumber disc herniation (LDH)

3. Multi segment LDH

4. Patients younger than 18 years or older than 60 years

5. Patients with hypersensitivity to one of the used drugs

6. Patients suffering of coagulopathy

7. Operation time more than 1 hour

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egyptian Center for Research and Regenerative Medicine

OTHER_GOV

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Maha Salah

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

International Medical Center

Cairo, , Egypt

Countries

Egypt

Other Identifiers

6/02-2025

Identifier Type: -

Identifier Source: org_study_id