Pregabalin is an Effective Treatment for Acute Postoperative Pain Following Spinal Surgery Without Major Side Effects
Efficacy and Side Effect Profile of Varying Dose of Pregabalin for the Treatment of Acute Postoperative Pain Following Spinal Surgery
1 other identifier
interventional
132
0 countries
N/A
Brief Summary
The objective of this study is to examine the efficacy and side effect of varying dose of pregabalin for the treatment of postoperative pain after spinal surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 postoperative-pain
Started Oct 2022
Longer than P75 for phase_4 postoperative-pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2022
CompletedFirst Posted
Study publicly available on registry
July 28, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJuly 28, 2022
July 1, 2022
3.3 years
June 6, 2022
July 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
Pain intensity
Change of Visual analogue scale (VAS) pain score
Arrival at the general ward
Pain intensity
Change of Visual analogue scale (VAS) pain score
6hours after surgery
Pain intensity
Change of Visual analogue scale (VAS) pain score
24hours after surgery
Pain intensity
Change of Visual analogue scale (VAS) pain score
48hours after surgery
Pain intensity
Change of Visual analogue scale (VAS) pain score
72hours after surgery
IV PCA usage
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
Arrival at the general ward
IV PCA usage
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
6hours after surgery
IV PCA usage
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
24hours after surgery
IV PCA usage
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
48hours after surgery
IV PCA usage
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
72hours after surgery
Rescue analgesic usage
Frequency of rescue analgesic administered
Arrival at the general ward
Rescue analgesic usage
Frequency of rescue analgesic administered
6hours after surgery
Rescue analgesic usage
Frequency of rescue analgesic administered
24hours after surgery
Rescue analgesic usage
Frequency of rescue analgesic administered
48hours after surgery
Rescue analgesic usage
Frequency of rescue analgesic administered
72hours after surgery
Secondary Outcomes (1)
Nausea and vomiting due to IV PCA usage
From arrival at general ward after sugery for 72 hours, subdivided into 4 periods (1-6hours, 6-24hours, 24-48hours, 48-72hours)
Study Arms (4)
Placebo
PLACEBO COMPARATOR3 capsules of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours
Pregabalin 25mg
EXPERIMENTAL1 capsule of Kabalin 25mg Cap and 2 pills of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours
Pregabalin 50mg
EXPERIMENTAL2 capsules of Kabalin 25mg Cap and 1 pill of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours
Pregabalin 75mg
EXPERIMENTAL3 capsules of Kabalin 25mg Cap are administered once prior to surgery and every 12 hours after surgery for 72 hours
Interventions
Patients are given 0 to 3 capsules per administration according to their allocated group.
Patients are given 0 to 3 capsules per administration according to their allocated group.
Eligibility Criteria
You may qualify if:
- Adult patient undergoing spine surgery at out institution for degenerative lumbar disorder.
You may not qualify if:
- ASA classification over 2
- Patients with dizziness or frequent headache
- Active alcohol or drug usage
- Intake of any analgesics daily or 48 hours before surgery
- Impaired renal and/or hepatic function
- Diagnosed and being treated for anxiety or depression disorders
- Coverage from worker's compensation insurance or car insurance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ajou University School of Medicinelead
- HK inno.N Corporationcollaborator
Related Publications (5)
Helenius L, Yrjala T, Oksanen H, Pajulo O, Loyttyniemi E, Taittonen M, Helenius I. Pregabalin and Persistent Postoperative Pain Following Posterior Spinal Fusion in Children and Adolescents: A Randomized Clinical Trial. J Bone Joint Surg Am. 2021 Dec 1;103(23):2200-2206. doi: 10.2106/JBJS.21.00153. Epub 2021 Aug 23.
PMID: 34424869BACKGROUNDHelenius LL, Oksanen H, Lastikka M, Pajulo O, Loyttyniemi E, Manner T, Helenius IJ. Preemptive Pregabalin in Children and Adolescents Undergoing Posterior Instrumented Spinal Fusion: A Double-Blinded, Placebo-Controlled, Randomized Clinical Trial. J Bone Joint Surg Am. 2020 Feb 5;102(3):205-212. doi: 10.2106/JBJS.19.00650.
PMID: 31770296BACKGROUNDKim JC, Choi YS, Kim KN, Shim JK, Lee JY, Kwak YL. Effective dose of peri-operative oral pregabalin as an adjunct to multimodal analgesic regimen in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2011 Mar 15;36(6):428-33. doi: 10.1097/BRS.0b013e3181d26708.
PMID: 21372654BACKGROUNDPanse NA, Adate KU, Panchal SH. Comparative Evaluation of Two Different Doses of Pre-Emptive Oral Pregabalin on Duration of Spinal Anesthesia and Postoperative Pain. Archives of Anesthesiology and Critical Care. 2021;7(2):75-81
BACKGROUNDPark KH, Chung NS, Chung HW, Kim TY, Lee HD. Pregabalin as an effective treatment for acute postoperative pain following spinal surgery without major side effects: protocol for a prospective, randomized controlled, double-blinded trial. Trials. 2023 Jun 22;24(1):422. doi: 10.1186/s13063-023-07438-2.
PMID: 37349841DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Han-Dong Lee, Prof.
Ajou University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 6, 2022
First Posted
July 28, 2022
Study Start
October 1, 2022
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
July 28, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share