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

Phase 4

Not yet recruiting

• Conditions: Pregabalin; Spine Surgery; Adverse Reaction to Pregabalin; Postoperative Pain
• Interventions: Drug: Pregabalin 25 MG; Drug: Placebo

• Registration Number: NCT05478382
• Lead Sponsor: Ajou University School of Medicine

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.

Study Timeline

• Study First Submitted: 2022-06-06
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-26
• Last Update Submitted: 2022-07-26
• Study First Posted: 2022-07-28
• Last Update Posted: 2022-07-28
• Study Start: 2022-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin 25mg	Pregabalin 25 MG	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 50mg	Pregabalin 25 MG	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 25mg	Placebo	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 50mg	Placebo	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
Placebo	Placebo	3 capsules of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours
Pregabalin 75mg	Pregabalin 25 MG	3 capsules of Kabalin 25mg Cap are administered once prior to surgery and every 12 hours after surgery for 72 hours

Primary Outcome Measures

Name	Time	Method
Rescue analgesic usage	72hours after surgery	Frequency of rescue analgesic administered
IV PCA usage	72hours after surgery	amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
Pain intensity	72hours after surgery	Change of Visual analogue scale (VAS) pain score

Secondary Outcome Measures

Name	Time	Method
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