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

NCT ID: NCT05478382

Last Updated: 2022-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Postoperative Pain Pregabalin Spine Surgery Adverse Reaction to Pregabalin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients are given 0 to 3 capsules per administration according to their allocated group.

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

Group Type EXPERIMENTAL

Pregabalin 25 MG

Intervention Type DRUG

Patients are given 0 to 3 capsules per administration according to their allocated group.

Placebo

Intervention Type DRUG

Patients are given 0 to 3 capsules per administration according to their allocated group.

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

Group Type EXPERIMENTAL

Pregabalin 25 MG

Intervention Type DRUG

Patients are given 0 to 3 capsules per administration according to their allocated group.

Placebo

Intervention Type DRUG

Patients are given 0 to 3 capsules per administration according to their allocated group.

Pregabalin 75mg

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

Group Type EXPERIMENTAL

Pregabalin 25 MG

Intervention Type DRUG

Patients are given 0 to 3 capsules per administration according to their allocated group.

Interventions

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Pregabalin 25 MG

Patients are given 0 to 3 capsules per administration according to their allocated group.

Intervention Type DRUG

Placebo

Patients are given 0 to 3 capsules per administration according to their allocated group.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role collaborator

Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Han Dong Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Han-Dong Lee, Prof.

Role: PRINCIPAL_INVESTIGATOR

Ajou University Medical Center

Central Contacts

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Han-Dong Lee, Prof.

Role: CONTACT

82312195220

Kihoon Park, Dr.

Role: CONTACT

82312197378

References

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Helenius L, Yrjala T, Oksanen H, Pajulo O, Loyttyniemi 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 Dec 1;103(23):2200-2206. doi: 10.2106/JBJS.21.00153. Epub 2021 Aug 23.

Reference Type BACKGROUND
PMID: 34424869 (View on PubMed)

Helenius LL, Oksanen H, Lastikka M, Pajulo O, Loyttyniemi 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.

Reference Type BACKGROUND
PMID: 31770296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21372654 (View on PubMed)

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

Reference Type BACKGROUND

Park KH, Chung NS, Chung HW, Kim TY, Lee HD. Pregabalin as an effective treatment for acute postoperative pain following spinal surgery without major side effects: protocol for a prospective, randomized controlled, double-blinded trial. Trials. 2023 Jun 22;24(1):422. doi: 10.1186/s13063-023-07438-2.

Reference Type DERIVED
PMID: 37349841 (View on PubMed)

Other Identifiers

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KAB 1.0

Identifier Type: -

Identifier Source: org_study_id

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