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

Efficacy and Side Effect Profile of Varying Dose of Pregabalin for the Treatment of Acute Postoperative Pain Following Spinal Surgery

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 Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Spine Surgery; Pregabalin; Adverse Reaction to Pregabalin
• Intervention / Treatment: Drug: Placebo; Drug: Pregabalin 25 MG

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 Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Han-Dong Lee, Prof.; Phone Number: 82312195220; Email: ajouosspine@gmail.com
• Study Contact Backup: Name: Kihoon Park, Dr.; Phone Number: 82312197378; Email: kihoon05@aumc.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 3 capsules of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours	Drug: Placebo; Patients are given 0 to 3 capsules per administration according to their allocated group.
Experimental: Pregabalin 25mg; 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	Drug: Placebo; Patients are given 0 to 3 capsules per administration according to their allocated group.; Drug: Pregabalin 25 MG; Patients are given 0 to 3 capsules per administration according to their allocated group.
Experimental: Pregabalin 50mg; 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	Drug: Placebo; Patients are given 0 to 3 capsules per administration according to their allocated group.; Drug: Pregabalin 25 MG; Patients are given 0 to 3 capsules per administration according to their allocated group.
Experimental: Pregabalin 75mg; 3 capsules of Kabalin 25mg Cap are administered once prior to surgery and every 12 hours after surgery for 72 hours	Drug: Pregabalin 25 MG; Patients are given 0 to 3 capsules per administration according to their allocated group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Change of Visual analogue scale (VAS) pain score	Arrival at the general ward
Pain intensity	Change of Visual analogue scale (VAS) pain score	6hours after surgery
Pain intensity	Change of Visual analogue scale (VAS) pain score	24hours after surgery
Pain intensity	Change of Visual analogue scale (VAS) pain score	48hours after surgery
Pain intensity	Change of Visual analogue scale (VAS) pain score	72hours after surgery
IV PCA usage	amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)	Arrival at the general ward
IV PCA usage	amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)	6hours after surgery
IV PCA usage	amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)	24hours after surgery
IV PCA usage	amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)	48hours after surgery
IV PCA usage	amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)	72hours after surgery
Rescue analgesic usage	Frequency of rescue analgesic administered	Arrival at the general ward
Rescue analgesic usage	Frequency of rescue analgesic administered	6hours after surgery
Rescue analgesic usage	Frequency of rescue analgesic administered	24hours after surgery
Rescue analgesic usage	Frequency of rescue analgesic administered	48hours after surgery
Rescue analgesic usage	Frequency of rescue analgesic administered	72hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea and vomiting due to IV PCA usage	Incidence and frequency of nausea and vomiting event 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)

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Collaborators: HK inno.N Corporation
• Investigators: Principal Investigator: Han-Dong Lee, Prof., Ajou University Medical Center

Publications and helpful links

General Publications

• Helenius L, Yrjälä T, Oksanen H, Pajulo O, Löyttyniemi 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. [Epub ahead of print]
• Helenius LL, Oksanen H, Lastikka M, Pajulo O, Löyttyniemi 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.
• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative Pain; pregabalin; Spine surgery; adverse reaction to pregabalin
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: KAB 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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