Anterior Cruciate Ligament (ACL) ReconstructionNCT03211728
Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?
A study testing pregabalin in people with Anterior Cruciate Ligament (ACL) Reconstruction, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators hypothesize that perioperative oral administration of pregabalin would reduce postoperative pain and produce reduction in postoperative opioid consumption after anterior cruciate ligament (ACL) reconstruction . Patients are randomly assign to 1 of 2 groups. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Reconstruction
- What is being tested?
- pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jul 2017to 8 Feb 2019
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 20-65 years
- physical condition type I or II in ASA (American Society of Anesthesiology)
Who cannot join
- patients of ASA classification 3 or more
- with a history of cardiovascular or respiratory disease
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 03722
About this study
The investigators hypothesize that perioperative oral administration of pregabalin would reduce postoperative pain and produce reduction in postoperative opioid consumption after anterior cruciate ligament (ACL) reconstruction . Patients are randomly assign to 1 of 2 groups. The placebo group receive placebo capsules 1 hour before surgery and 12 hours after initial dose. The pregabalin group receive pregabalin 150 mg, respectively at the same points.
- Being tested
- pregabalin, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalinDrug
The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose.
placeboDrug
The placebo group receive placebo 150 mg 1 hour before surgery and 12 hours after initial dose.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Drug: pregabalin |
| placebo group | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores
Visual analog scale (VAS) score = 0-100 mm
Measured: 12 hours after surgery
Postoperative pain scores
Visual analog scale (VAS) score = 0-100 mm
Measured: 24 hours after surgery
Postoperative pain scores
Visual analog scale (VAS) score = 0-100 mm
Measured: 36 hours after surgery
Postoperative pain scores
Visual analog scale (VAS) score = 0-100 mm
Measured: 2 weeks after surgery
Secondary outcomes (1)
Opioid consumption
Measured: the first 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start19 Jul 2017
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament (ACL) ReconstructionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Candidate for arthroscopic ACL reconstruction are divided into two groups of pregabalin and placebo with 48 patients in each group. The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose and a placebo is administered in control group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211728
- Sponsor's protocol ID
- 4-2017-0415
- Status last verified
- Feb 2019
- First submitted
- 6 Jul 2017
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?
- ClinicalTrials.gov ID
- NCT03211728
- Acronym / sponsor ID
- 4-2017-0415
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 7 Jul 2017 (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 investigators hypothesize that perioperative oral administration of pregabalin would reduce postoperative pain and produce reduction in postoperative opioid consumption after anterior cruciate ligament (ACL) reconstruction . Patients are randomly assign to 1 of 2 groups. The placebo group receive placebo capsules 1 hour before surgery and 12 hours after initial dose. The pregabalin group receive pregabalin 150 mg, respectively at the same points.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Candidate for arthroscopic ACL reconstruction are divided into two groups of pregabalin and placebo with 48 patients in each group. The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose and a placebo is administered in control group.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: pregabalin |
| placebo group | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 20-65 years
- physical condition type I or II in ASA (American Society of Anesthesiology)
Key exclusion criteria (6 listed)
- patients of ASA classification 3 or more
- with a history of cardiovascular or respiratory disease
- dizziness or frequent headache
- active alcohol or drug usage,
- intake of any analgesics daily or 48 hours before surgery
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 |
|---|---|---|
| pregabalinThe intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose. | Drug | experimental group |
| placeboThe placebo group receive placebo 150 mg 1 hour before surgery and 12 hours after initial dose. | Drug | placebo group |
Primary outcome
Postoperative pain scores
Time frame: 12 hours after surgery
Visual analog scale (VAS) score = 0-100 mm
Postoperative pain scores
Time frame: 24 hours after surgery
Visual analog scale (VAS) score = 0-100 mm
Postoperative pain scores
Time frame: 36 hours after surgery
Visual analog scale (VAS) score = 0-100 mm
Postoperative pain scores
Time frame: 2 weeks after surgery
Visual analog scale (VAS) score = 0-100 mm
1 secondary outcome
Opioid consumption
Time frame: the first 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament (ACL) Reconstruction
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pregabalin in people with Anterior Cruciate Ligament (ACL) Reconstruction, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain scores (time frame: 12 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2019.