Back to resultsRCT - Epidural Anesthetic Cocktail Following Endoscopic Lumbar Discectomy
Primary Purpose
Lumbar Disc Herniation
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Epidural Anesthetic Cocktail
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation
Eligibility Criteria
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
Sites / Locations
- Queen Savang Vadhana Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Epidural Anesthetic Cocktail
Placebo
Arm Description
Patients which received epidural anesthetic cocktail following endoscopic discectomy
Patients which received placebo following endoscopic discectomy
Outcomes
Primary Outcome Measures
Oswestry Disability Index (ODI)
To compare efficacy of patient-reported functional outcomes achieved with epidural cocktail, measured as Oswestry Disability Index (ODI) at 3 months
Secondary Outcome Measures
Functional Outcomes
ODI, VAS of leg pain, VAS of back pain, Modified Macnab score
Postoperative outcomes
Time at first dose analgesia, Post-op opioid consumption, complication, time return to work
Full Information
NCT ID
NCT05738759
First Posted
August 21, 2022
Last Updated
February 21, 2023
Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
1. Study Identification
Unique Protocol Identification Number
NCT05738759
Brief Title
RCT - Epidural Anesthetic Cocktail Following Endoscopic Lumbar Discectomy
Official Title
Comparative Outcomes of Intraoperative Epidural Application of Anesthetic Cocktail Following Endoscopic Lumbar Discectomy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were divided into two groups using computer-generated block-of-four randomization. The experimental group received epidural anesthetic cocktail following endoscopic discectomy, while the control group received placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epidural Anesthetic Cocktail
Arm Type
Experimental
Arm Description
Patients which received epidural anesthetic cocktail following endoscopic discectomy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients which received placebo following endoscopic discectomy
Intervention Type
Drug
Intervention Name(s)
Epidural Anesthetic Cocktail
Other Intervention Name(s)
Cocktail
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo is soaked with NSS in the gelfoam size 1x2 cm as well and applied on the epidura before removal of the endoscope.
Primary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
To compare efficacy of patient-reported functional outcomes achieved with epidural cocktail, measured as Oswestry Disability Index (ODI) at 3 months
Time Frame
3rd month
Secondary Outcome Measure Information:
Title
Functional Outcomes
Description
ODI, VAS of leg pain, VAS of back pain, Modified Macnab score
Time Frame
POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr
Title
Postoperative outcomes
Description
Time at first dose analgesia, Post-op opioid consumption, complication, time return to work
Time Frame
POD 1st day, 1st wk, 6th wk, 3th mo, 6th mo, 1st yr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Surachat Jaroenwareekul, M.D.
Phone
+66804599680
Email
surachatjwk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Khanathip Jitphakdee, M.D.
Phone
+66912582050
Email
khanathip@yahoo.com
Facility Information:
Facility Name
Queen Savang Vadhana Memorial Hospital
City
Chon Buri
ZIP/Postal Code
20110
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surachat Jaroenwareekul, M.D.
Phone
+6638322157
Email
Surachatjwk@gmail.com
First Name & Middle Initial & Last Name & Degree
Chuenrutai Yeekian, Ph.D.
Phone
+6638322157
Ext
23468
Email
jayeekian88@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data was save in form of microsoft excel spreadsheet and SPSS file
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RCT - Epidural Anesthetic Cocktail Following Endoscopic Lumbar Discectomy
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