Adverse Reaction to Pregabalin, Postoperative Pain, Pregabalin, Spine Surgery
Conditions
Keywords
Postoperative Pain, pregabalin, Spine surgery, adverse reaction to pregabalin
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.
Interventions
DRUGPregabalin 25 MG
Patients are given 0 to 3 capsules per administration according to their allocated group.
DRUGPlacebo
Patients are given 0 to 3 capsules per administration according to their allocated group.
Sponsors
HK inno.N Corporation
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Arrival at the general ward | Change of Visual analogue scale (VAS) pain score |
| IV PCA usage | Arrival at the general ward | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) |
| Rescue analgesic usage | Arrival at the general ward | Frequency of rescue analgesic administered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Incidence and frequency of nausea and vomiting event due to IV PCA usage |
Contacts
Primary ContactHan-Dong Lee, Prof.
Backup ContactKihoon Park, Dr.
Outcome results
None listed