RCT - Epidural Anesthetic Cocktail Following Endoscopic Lumbar Discectomy

April 2, 2024 updated by: Queen Savang Vadhana Memorial Hospital, Thailand

Comparative Outcomes of Intraoperative Epidural Application of Anesthetic Cocktail Following Endoscopic Lumbar Discectomy: A Randomized Controlled Trial

The study aims to study the effect of intraoperative epidural application of anesthetic cocktail following endoscopic lumbar discectomy in improving postoperative pain, length of hospital stay, time at first dose analgesia, post-operative opioid consumption, functional outcomes, time return to work, and postoperative complications

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial study the effects of epidural anesthetic cocktail. The cocktail, consists of triamcinolone 40 mg, marcaine 5 mg, and morphine 3 mg, is soaked in the gelfoam size 1x2 cm and applied on the epidura before removal of the endoscope. 54 participants are deivided into two arms, experimental and placebo group, and randomized into the trial. Primary objective is the ODI score from patient-reported function outcome at 3 months with secondary objective as mentioned above.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Chon Buri, Thailand, 20110
        • Recruiting
        • Queen Savang Vadhana Memorial Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-60
  • Lumbar radiculopathy
  • No prior spinal surgery or recurrent lumbar disc herniation
  • Plan for endoscopic discectomy after failed conservative for at least 6 weeks
  • Single-level herniation confirmed by MRI which correlated with symptoms

Exclusion Criteria:

  • Allergic or contraindicated to amide-type anesthesia, opioid, NSAIDs, or steroids
  • Cauda equina syndrome
  • Concomitant with other abnormalities
  • Unable to answer questionnaires
  • Cannot tolerate surgery due to medical comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epidural Anesthetic Cocktail
Patients which received epidural anesthetic cocktail following endoscopic discectomy
Drug: Epidural Anesthetic Cocktail
The anesthetic cocktail, consists of triamcinolone 40 mg, marcaine 5 mg, and morphine 3 mg, is soaked in the gelfoam size 1x2 cm and applied on the epidura before removal of the endoscope.
Other Names:
  • Cocktail
Placebo Comparator: Placebo
Patients which received placebo following endoscopic discectomy
Drug: Placebo
The placebo is soaked with NSS in the gelfoam size 1x2 cm as well and applied on the epidura before removal of the endoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: 3rd month
To compare efficacy of patient-reported functional outcomes achieved with epidural cocktail, measured as Oswestry Disability Index (ODI) at 3 months
3rd month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Outcomes
Time Frame: POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr
ODI, VAS of leg pain, VAS of back pain, Modified Macnab score
POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr
Postoperative outcomes
Time Frame: POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr
Time at first dose analgesia, Post-op opioid consumption, complication, time return to work
POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

August 21, 2022

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Actual)

February 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 013/2565

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data was save in form of microsoft excel spreadsheet and SPSS file

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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