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

Ajou University School of Medicine

Status and phase: Not yet enrolling; Phase 4

Conditions: Spine Surgery; Postoperative Pain; Pregabalin; Adverse Reaction to Pregabalin

Treatments: Drug: Pregabalin 25 MG; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05478382

KAB 1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Pregabalin 25mg

Experimental group

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

Treatment:

Drug: Pregabalin 25 MG

Drug: Placebo

Pregabalin 50mg

Experimental group

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

Treatment:

Drug: Pregabalin 25 MG

Drug: Placebo

Pregabalin 75mg

Experimental group

Description:

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

Treatment:

Drug: Pregabalin 25 MG