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

• Sponsor: Ajou University School of Medicine (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05478382
• Collaborator: HK inno.N Corporation (Industry)
• Enrollment: 132
• Arms: 4
• Anticipated Duration (Months): 39

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Pregabalin; Spine Surgery; Adverse Reaction to Pregabalin	Drug: Pregabalin 25 MG; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy and Side Effect Profile of Varying Dose of Pregabalin for the Treatment of Acute Postoperative Pain Following Spinal Surgery
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain intensity [Arrival at the general ward]

   Change of Visual analogue scale (VAS) pain score

2. Pain intensity [6hours after surgery]

   Change of Visual analogue scale (VAS) pain score

3. Pain intensity [24hours after surgery]

   Change of Visual analogue scale (VAS) pain score

4. Pain intensity [48hours after surgery]

   Change of Visual analogue scale (VAS) pain score

5. Pain intensity [72hours after surgery]

   Change of Visual analogue scale (VAS) pain score

6. IV PCA usage [Arrival at the general ward]

   amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)

7. IV PCA usage [6hours after surgery]

   amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)

8. IV PCA usage [24hours after surgery]

   amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)

9. IV PCA usage [48hours after surgery]

   amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)

10. IV PCA usage [72hours after surgery]

    amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)

11. Rescue analgesic usage [Arrival at the general ward]

    Frequency of rescue analgesic administered

12. Rescue analgesic usage [6hours after surgery]

    Frequency of rescue analgesic administered

13. Rescue analgesic usage [24hours after surgery]

    Frequency of rescue analgesic administered

14. Rescue analgesic usage [48hours after surgery]

    Frequency of rescue analgesic administered

15. Rescue analgesic usage [72hours after surgery]

    Frequency of rescue analgesic administered

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ajou University School of Medicine
• HK inno.N Corporation

Investigators

• Principal Investigator: Han-Dong Lee, Prof., Ajou University Medical Center

Study Documents (Full-Text)

None provided.

More Information

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

• Responsible Party: Han Dong Lee, Assistant Professor, Ajou University School of Medicine
• ClinicalTrials.gov Identifier: NCT05478382
• Other Study ID Numbers: KAB 1.0
• First Posted: Jul 28, 2022
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Han Dong Lee, Assistant Professor, Ajou University School of Medicine: Postoperative Pain; pregabalin; Spine surgery; adverse reaction to pregabalin
• Additional relevant MeSH terms: Pain, Postoperative; Pregabalin

Study Results

No Results Posted as of Jul 28, 2022