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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05478382
• Other study ID #: KAB 1.0
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2022
• Source: Ajou University School of Medicine
• Contact: Han-Dong Lee, Prof.
• Phone: 82312195220
• Email: ajouosspine[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Pregabalin
• Spine Surgery

Intervention

Drug:
• Pregabalin 25 MG
Patients are given 0 to 3 capsules per administration according to their allocated group.
• Placebo
Patients are given 0 to 3 capsules per administration according to their allocated group.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ajou University School of Medicine	HK inno.N Corporation

References & Publications (4)

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] — View Citation

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. — View 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. — View 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

Outcome

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