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

July 26, 2022 updated by: Han Dong Lee, Ajou University School of Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Arrival at the general ward
Change of Visual analogue scale (VAS) pain score
Arrival at the general ward
Pain intensity
Time Frame: 6hours after surgery
Change of Visual analogue scale (VAS) pain score
6hours after surgery
Pain intensity
Time Frame: 24hours after surgery
Change of Visual analogue scale (VAS) pain score
24hours after surgery
Pain intensity
Time Frame: 48hours after surgery
Change of Visual analogue scale (VAS) pain score
48hours after surgery
Pain intensity
Time Frame: 72hours after surgery
Change of Visual analogue scale (VAS) pain score
72hours after surgery
IV PCA usage
Time Frame: Arrival at the general ward
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
Arrival at the general ward
IV PCA usage
Time Frame: 6hours after surgery
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
6hours after surgery
IV PCA usage
Time Frame: 24hours after surgery
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
24hours after surgery
IV PCA usage
Time Frame: 48hours after surgery
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
48hours after surgery
IV PCA usage
Time Frame: 72hours after surgery
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
72hours after surgery
Rescue analgesic usage
Time Frame: Arrival at the general ward
Frequency of rescue analgesic administered
Arrival at the general ward
Rescue analgesic usage
Time Frame: 6hours after surgery
Frequency of rescue analgesic administered
6hours after surgery
Rescue analgesic usage
Time Frame: 24hours after surgery
Frequency of rescue analgesic administered
24hours after surgery
Rescue analgesic usage
Time Frame: 48hours after surgery
Frequency of rescue analgesic administered
48hours after surgery
Rescue analgesic usage
Time Frame: 72hours after surgery
Frequency of rescue analgesic administered
72hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nausea and vomiting due to IV PCA usage
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ajou University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
HK inno.N Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Han-Dong Lee, Prof., Ajou University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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