Pregabalin is an Effective Treatment for Acute Postoperative Pain Following Spinal Surgery Without Major Side Effects
NCT ID: NCT05478382
Last Updated: 2022-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
132 participants
INTERVENTIONAL
2022-10-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
3 capsules of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours
Placebo
Patients are given 0 to 3 capsules per administration according to their allocated group.
Pregabalin 25mg
1 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 25 MG
Patients are given 0 to 3 capsules per administration according to their allocated group.
Placebo
Patients are given 0 to 3 capsules per administration according to their allocated group.
Pregabalin 50mg
2 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 25 MG
Patients are given 0 to 3 capsules per administration according to their allocated group.
Placebo
Patients are given 0 to 3 capsules per administration according to their allocated group.
Pregabalin 75mg
3 capsules of Kabalin 25mg Cap are administered once prior to surgery and every 12 hours after surgery for 72 hours
Pregabalin 25 MG
Patients are given 0 to 3 capsules per administration according to their allocated group.
Interventions
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Pregabalin 25 MG
Patients are given 0 to 3 capsules per administration according to their allocated group.
Placebo
Patients are given 0 to 3 capsules per administration according to their allocated group.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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HK inno.N Corporation
INDUSTRY
Ajou University School of Medicine
OTHER
Responsible Party
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Han Dong Lee
Assistant Professor
Principal Investigators
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Han-Dong Lee, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ajou University Medical Center
Central Contacts
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References
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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.
Helenius 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.
Kim 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.
Panse 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
Park 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.
Other Identifiers
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KAB 1.0
Identifier Type: -
Identifier Source: org_study_id
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