Clinical trial NCT05478382: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Postoperative Pain
Pregabalin
Spine Surgery
Adverse Reaction to Pregabalin
Keywords: Postoperative Pain
pregabalin
Spine surgery
adverse reaction to pregabalin
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: HK inno.N Corporation
First posted: 2022-07-28
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain intensity
timeFrame: Arrival at the general ward
measure: Pain intensity
timeFrame: 6hours after surgery
measure: Pain intensity
timeFrame: 24hours after surgery
measure: Pain intensity
timeFrame: 48hours after surgery
measure: Pain intensity
timeFrame: 72hours after surgery
measure: IV PCA usage
timeFrame: Arrival at the general ward
measure: IV PCA usage
timeFrame: 6hours after surgery
measure: IV PCA usage
timeFrame: 24hours after surgery
measure: IV PCA usage
timeFrame: 48hours after surgery
measure: IV PCA usage
timeFrame: 72hours after surgery
measure: Rescue analgesic usage
timeFrame: Arrival at the general ward
measure: Rescue analgesic usage
timeFrame: 6hours after surgery
measure: Rescue analgesic usage
timeFrame: 24hours after surgery
measure: Rescue analgesic usage
timeFrame: 48hours after surgery
measure: Rescue analgesic usage
timeFrame: 72hours after surgery
Secondary outcomes:
measure: Nausea and vomiting due to IV PCA usage
timeFrame: From arrival at general ward after sugery for 72 hours, subdivided into 4 periods (1-6hours, 6-24hours, 24-48hours, 48-72hours)
Other outcomes:
Locations:
Study officials:
affiliation: Ajou University Medical Center
name: Han-Dong Lee, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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 Dec 1;103(23):2200-2206. doi: 10.2106/JBJS.21.00153. Epub 2021 Aug 23.
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.
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.
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