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Pregabalin is an Effective Treatment for Acute Postoperative Pain Following Spinal Surgery Without Major Side Effects

Primary Purpose

Postoperative Pain, Pregabalin, Spine Surgery

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pregabalin 25 MG
Placebo
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative Pain, pregabalin, Spine surgery, adverse reaction to pregabalin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo

    Pregabalin 25mg

    Pregabalin 50mg

    Pregabalin 75mg

    Arm Description

    3 capsules of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours

    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

    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

    3 capsules of Kabalin 25mg Cap are administered once prior to surgery and every 12 hours after surgery for 72 hours

    Outcomes

    Primary Outcome Measures

    Pain intensity
    Change of Visual analogue scale (VAS) pain score
    Pain intensity
    Change of Visual analogue scale (VAS) pain score
    Pain intensity
    Change of Visual analogue scale (VAS) pain score
    Pain intensity
    Change of Visual analogue scale (VAS) pain score
    Pain intensity
    Change of Visual analogue scale (VAS) pain score
    IV PCA usage
    amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
    IV PCA usage
    amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
    IV PCA usage
    amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
    IV PCA usage
    amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
    IV PCA usage
    amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
    Rescue analgesic usage
    Frequency of rescue analgesic administered
    Rescue analgesic usage
    Frequency of rescue analgesic administered
    Rescue analgesic usage
    Frequency of rescue analgesic administered
    Rescue analgesic usage
    Frequency of rescue analgesic administered
    Rescue analgesic usage
    Frequency of rescue analgesic administered

    Secondary Outcome Measures

    Nausea and vomiting due to IV PCA usage
    Incidence and frequency of nausea and vomiting event due to IV PCA usage

    Full Information

    First Posted
    June 6, 2022
    Last Updated
    July 26, 2022
    Sponsor
    Ajou University School of Medicine
    Collaborators
    HK inno.N Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05478382
    Brief Title
    Pregabalin is an Effective Treatment for Acute Postoperative Pain Following Spinal Surgery Without Major Side Effects
    Official Title
    Efficacy and Side Effect Profile of Varying Dose of Pregabalin for the Treatment of Acute Postoperative Pain Following Spinal Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ajou University School of Medicine
    Collaborators
    HK inno.N Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Patients experience considerable postoperative pain after spine surgery. Because the spine is located at the center of the body and supports body weight, severe postoperative pain hinders upper body elevation and gait which can lead to various complications such as pulmonary deterioration or pressure sores. It is important to effectively control postoperative pain to prevent such complications. Gabanoids are widely used as preemptive multimodal analgesia while their effects and side effects are known to be dose dependent. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Pregabalin, Spine Surgery, Adverse Reaction to Pregabalin
    Keywords
    Postoperative Pain, pregabalin, Spine surgery, adverse reaction to pregabalin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    132 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    3 capsules of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours
    Arm Title
    Pregabalin 25mg
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Pregabalin 50mg
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Pregabalin 75mg
    Arm Type
    Experimental
    Arm Description
    3 capsules of Kabalin 25mg Cap are administered once prior to surgery and every 12 hours after surgery for 72 hours
    Intervention Type
    Drug
    Intervention Name(s)
    Pregabalin 25 MG
    Intervention Description
    Patients are given 0 to 3 capsules per administration according to their allocated group.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Patients are given 0 to 3 capsules per administration according to their allocated group.
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Change of Visual analogue scale (VAS) pain score
    Time Frame
    Arrival at the general ward
    Title
    Pain intensity
    Description
    Change of Visual analogue scale (VAS) pain score
    Time Frame
    6hours after surgery
    Title
    Pain intensity
    Description
    Change of Visual analogue scale (VAS) pain score
    Time Frame
    24hours after surgery
    Title
    Pain intensity
    Description
    Change of Visual analogue scale (VAS) pain score
    Time Frame
    48hours after surgery
    Title
    Pain intensity
    Description
    Change of Visual analogue scale (VAS) pain score
    Time Frame
    72hours after surgery
    Title
    IV PCA usage
    Description
    amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
    Time Frame
    Arrival at the general ward
    Title
    IV PCA usage
    Description
    amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
    Time Frame
    6hours after surgery
    Title
    IV PCA usage
    Description
    amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
    Time Frame
    24hours after surgery
    Title
    IV PCA usage
    Description
    amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
    Time Frame
    48hours after surgery
    Title
    IV PCA usage
    Description
    amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
    Time Frame
    72hours after surgery
    Title
    Rescue analgesic usage
    Description
    Frequency of rescue analgesic administered
    Time Frame
    Arrival at the general ward
    Title
    Rescue analgesic usage
    Description
    Frequency of rescue analgesic administered
    Time Frame
    6hours after surgery
    Title
    Rescue analgesic usage
    Description
    Frequency of rescue analgesic administered
    Time Frame
    24hours after surgery
    Title
    Rescue analgesic usage
    Description
    Frequency of rescue analgesic administered
    Time Frame
    48hours after surgery
    Title
    Rescue analgesic usage
    Description
    Frequency of rescue analgesic administered
    Time Frame
    72hours after surgery
    Secondary Outcome Measure Information:
    Title
    Nausea and vomiting due to IV PCA usage
    Description
    Incidence and frequency of nausea and vomiting event due to IV PCA usage
    Time Frame
    From arrival at general ward after sugery for 72 hours, subdivided into 4 periods (1-6hours, 6-24hours, 24-48hours, 48-72hours)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Han-Dong Lee, Prof.
    Phone
    82312195220
    Email
    ajouosspine@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kihoon Park, Dr.
    Phone
    82312197378
    Email
    kihoon05@aumc.ac.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Han-Dong Lee, Prof.
    Organizational Affiliation
    Ajou University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34424869
    Citation
    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 Aug 23. doi: 10.2106/JBJS.21.00153. Online ahead of print.
    Results Reference
    background
    PubMed Identifier
    31770296
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21372654
    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.
    Results Reference
    background
    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
    Results Reference
    background

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    Pregabalin is an Effective Treatment for Acute Postoperative Pain Following Spinal Surgery Without Major Side Effects

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