Postoperative Pain Clinical Trial
Official title:
Efficacy and Side Effect Profile of Varying Dose of Pregabalin for the Treatment of Acute Postoperative Pain Following Spinal Surgery
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.
Status | Not yet recruiting |
Enrollment | 132 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patient undergoing spine surgery at out institution for degenerative lumbar disorder. Exclusion Criteria: - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ajou University School of Medicine | HK inno.N Corporation |
Helenius L, Yrjälä T, Oksanen H, Pajulo O, Löyttyniemi 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 Aug 23. doi: 10.2106/JBJS.21.00153. [Epub ahead of print] — View Citation
Helenius LL, Oksanen H, Lastikka M, Pajulo O, Löyttyniemi 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. — View Citation
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. — View Citation
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain intensity | Change of Visual analogue scale (VAS) pain score | Arrival at the general ward | |
Primary | Pain intensity | Change of Visual analogue scale (VAS) pain score | 6hours after surgery | |
Primary | Pain intensity | Change of Visual analogue scale (VAS) pain score | 24hours after surgery | |
Primary | Pain intensity | Change of Visual analogue scale (VAS) pain score | 48hours after surgery | |
Primary | Pain intensity | Change of Visual analogue scale (VAS) pain score | 72hours after surgery | |
Primary | IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | Arrival at the general ward | |
Primary | IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | 6hours after surgery | |
Primary | IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | 24hours after surgery | |
Primary | IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | 48hours after surgery | |
Primary | IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | 72hours after surgery | |
Primary | Rescue analgesic usage | Frequency of rescue analgesic administered | Arrival at the general ward | |
Primary | Rescue analgesic usage | Frequency of rescue analgesic administered | 6hours after surgery | |
Primary | Rescue analgesic usage | Frequency of rescue analgesic administered | 24hours after surgery | |
Primary | Rescue analgesic usage | Frequency of rescue analgesic administered | 48hours after surgery | |
Primary | Rescue analgesic usage | Frequency of rescue analgesic administered | 72hours after surgery | |
Secondary | Nausea and vomiting due to IV PCA usage | Incidence and frequency of nausea and vomiting event 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) |
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