Postoperative PainPhase 4NCT05478382
Pregabalin is an Effective Treatment for Acute Postoperative Pain Following Spinal Surgery Without Major Side Effects
A Phase 4 study testing Pregabalin 25 MG in people with Postoperative Pain and Pregabalin, run by Ajou University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Pregabalin, Spine Surgery
- What is being tested?
- Pregabalin 25 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient undergoing spine surgery at out institution for degenerative lumbar disorder.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- Pregabalin 25 MG, Placebo
- Keywords
- Postoperative Pain, pregabalin, Spine surgery, adverse reaction to pregabalin
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 25 MGDrug
Patients are given 0 to 3 capsules per administration according to their allocated group.
PlaceboDrug
Patients are given 0 to 3 capsules per administration according to their allocated group.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 3 capsules of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours Receives: Drug: Placebo |
| Pregabalin 25mg | Experimental | 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 Receives: Drug: Pregabalin 25 MG; Drug: Placebo |
| Pregabalin 50mg | Experimental | 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 Receives: Drug: Pregabalin 25 MG; Drug: Placebo |
| Pregabalin 75mg | Experimental | 3 capsules of Kabalin 25mg Cap are administered once prior to surgery and every 12 hours after surgery for 72 hours Receives: Drug: Pregabalin 25 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Change of Visual analogue scale (VAS) pain score
Measured: Arrival at the general ward
Pain intensity
Change of Visual analogue scale (VAS) pain score
Measured: 6hours after surgery
Pain intensity
Change of Visual analogue scale (VAS) pain score
Measured: 24hours after surgery
Pain intensity
Change of Visual analogue scale (VAS) pain score
Measured: 48hours after surgery
Pain intensity
Change of Visual analogue scale (VAS) pain score
Measured: 72hours after surgery
IV PCA usage
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
Measured: Arrival at the general ward
IV PCA usage
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
Measured: 6hours after surgery
IV PCA usage
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
Measured: 24hours after surgery
IV PCA usage
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
Measured: 48hours after surgery
IV PCA usage
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
Measured: 72hours after surgery
Rescue analgesic usage
Frequency of rescue analgesic administered
Measured: Arrival at the general ward
Rescue analgesic usage
Frequency of rescue analgesic administered
Measured: 6hours after surgery
Rescue analgesic usage
Frequency of rescue analgesic administered
Measured: 24hours after surgery
Rescue analgesic usage
Frequency of rescue analgesic administered
Measured: 48hours after surgery
Rescue analgesic usage
Frequency of rescue analgesic administered
Measured: 72hours after surgery
Secondary outcomes (1)
Nausea and vomiting due to IV PCA usage
Incidence and frequency of nausea and vomiting event due to IV PCA usage
Measured: From arrival at general ward after sugery for 72 hours, subdivided into 4 periods (1-6hours, 6-24hours, 24-48hours, 48-72hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study startOct 2022 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- HK inno.N Corporation
- Responsible party
- Principal investigator, Han Dong Lee, Ajou University School of Medicine
- Investigators
- Han-Dong Lee, Prof., Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478382
- Sponsor's protocol ID
- KAB 1.0
- Status last verified
- Jul 2022
- First submitted
- 6 Jun 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34424869Helenius 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.
PubMed 31770296Kim 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.
PubMed 21372654Panse 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
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.
PubMed 37349841
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Side Effect Profile of Varying Dose of Pregabalin for the Treatment of Acute Postoperative Pain Following Spinal Surgery
- ClinicalTrials.gov ID
- NCT05478382
- Acronym / sponsor ID
- KAB 1.0
- Keywords
- Postoperative Pain, pregabalin, Spine surgery, adverse reaction to pregabalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- HK inno.N Corporation
- Study start
- Oct 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo3 capsules of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours |
| Pregabalin 25mg | Experimental | Drug: Pregabalin 25 MG, Drug: Placebo1 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 |
| Pregabalin 50mg | Experimental | Drug: Pregabalin 25 MG, Drug: Placebo2 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 |
| Pregabalin 75mg | Experimental | Drug: Pregabalin 25 MG3 capsules of Kabalin 25mg Cap are administered once prior to surgery and every 12 hours after surgery for 72 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient undergoing spine surgery at out institution for degenerative lumbar disorder.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin 25 MGPatients are given 0 to 3 capsules per administration according to their allocated group. | Drug | Pregabalin 25mg, Pregabalin 50mg, Pregabalin 75mg |
| PlaceboPatients are given 0 to 3 capsules per administration according to their allocated group. | Drug | Placebo, Pregabalin 25mg, Pregabalin 50mg |
Primary outcome
Pain intensity
Time frame: Arrival at the general ward
Change of Visual analogue scale (VAS) pain score
Pain intensity
Time frame: 6hours after surgery
Change of Visual analogue scale (VAS) pain score
Pain intensity
Time frame: 24hours after surgery
Change of Visual analogue scale (VAS) pain score
Pain intensity
Time frame: 48hours after surgery
Change of Visual analogue scale (VAS) pain score
Pain intensity
Time frame: 72hours after surgery
Change of Visual analogue scale (VAS) pain score
IV PCA usage
Time frame: Arrival at the general ward
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
IV PCA usage
Time frame: 6hours after surgery
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
IV PCA usage
Time frame: 24hours after surgery
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
IV PCA usage
Time frame: 48hours after surgery
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
IV PCA usage
Time frame: 72hours after surgery
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
Rescue analgesic usage
Time frame: Arrival at the general ward
Frequency of rescue analgesic administered
Rescue analgesic usage
Time frame: 6hours after surgery
Frequency of rescue analgesic administered
Rescue analgesic usage
Time frame: 24hours after surgery
Frequency of rescue analgesic administered
Rescue analgesic usage
Time frame: 48hours after surgery
Frequency of rescue analgesic administered
Rescue analgesic usage
Time frame: 72hours after surgery
Frequency of rescue analgesic administered
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 34424869Helenius 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.
- Background: PubMed 31770296Helenius 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.
- Background: PubMed 21372654Kim 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.
- BackgroundPanse 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
- Derived from this study: PubMed 37349841Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han-Dong Lee, Prof. principal investigator
Ajou University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin 25 MG in people with Postoperative Pain and Pregabalin, run by Ajou University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han-Dong Lee, Prof. (82312195220, ajouosspine@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Arrival at the general ward). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05478382, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.