Anterior Cruciate Ligament (ACL) ReconstructionNCT07065266
Use of Simplified Pain Questionnaire Among People Receiving Anterior Cruciate Ligament (ACL) Knee Surgery?
A study testing Binary pain questionnaire and Numerical Pain Rating Scale (NPRS) in people with Anterior Cruciate Ligament (ACL) Reconstruction and Anterior Cruciate Ligament/Surgery, run by Stanford University at 1 site in United States.
Trial summary
The goal of this randomized clinical trial is to compare opioid consumption among patients who receive a binary pain scale compared to those who receive a standard 10-point pain scale after undergoing anterior cruciate ligament (ACL) reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Reconstruction, Anterior Cruciate Ligament/Surgery
- What is being tested?
- Binary pain questionnaire and Numerical Pain Rating Scale (NPRS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2020to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18+
- Undergoing ACL reconstruction surgery at Stanford Sports Medicine Redwood City, with autograft or allograft, with or without concomitant meniscal repair.
Who cannot join
- Pregnant women
- Surgical history of the operated knee
- Known allergy to opioid medications
- Received extra-routine pain care (as compared with the average ACL patients at the Sports Medicine division) given by the anesthesiologists, such as the postoperative epidural analgesia or the ultra-sound guided femoral nerve block.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford Orthopaedic and Sports Medicine
Redwood City, California, 94063
About this study
Official title: The Utility of a Dichotomous Pain Scale in Reducing Postoperative Opioids Consumption in Outpatient ACL Surgery: A Prospective Randomized Controlled Study
The goal of this randomized clinical trial is to compare opioid consumption among patients who receive a binary pain scale compared to those who receive a standard 10-point pain scale after undergoing anterior cruciate ligament (ACL) reconstruction surgery.
- Being tested
- Binary pain questionnaire, Numerical Pain Rating Scale (NPRS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binary pain questionnaireOther
Post-operative questionnaire that asks if pain is 'tolerable' or 'intolerable'
Numerical Pain Rating Scale (NPRS)Other
Standard 10-point pain scale used post-operatively to assess pain
| Study group | Role | What they receive |
|---|---|---|
| 10-point pain scale | Active comparator | participants undergoing ACL reconstructive surgery are asked to use a 10-point NPRS pain scale to describe their pain post-operatively Receives: Other: Numerical Pain Rating Scale (NPRS) |
| Binary pain questionnaire | Experimental | Participants undergoing ACL reconstructive surgery are asked to describe their pain as tolerable or intolerable post-operatively Receives: Other: Binary pain questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of opioid medication used post-operatively for 14 days
Measured: 14 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start24 Jul 2020
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
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 Stanford 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Alamin, Stanford University
- Investigators
- Todd Alamin, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065266
- Sponsor's protocol ID
- 45010
- Status last verified
- Jun 2026
- First submitted
- 3 Jul 2025
- Last updated
- 15 Jun 2026
- 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of a Dichotomous Pain Scale in Reducing Postoperative Opioids Consumption in Outpatient ACL Surgery: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07065266
- Acronym / sponsor ID
- 45010
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 15 Jul 2025 (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 goal of this randomized clinical trial is to compare opioid consumption among patients who receive a binary pain scale compared to those who receive a standard 10-point pain scale after undergoing anterior cruciate ligament (ACL) reconstruction surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10-point pain scale | Active comparator | Other: Numerical Pain Rating Scale (NPRS)participants undergoing ACL reconstructive surgery are asked to use a 10-point NPRS pain scale to describe their pain post-operatively |
| Binary pain questionnaire | Experimental | Other: Binary pain questionnaireParticipants undergoing ACL reconstructive surgery are asked to describe their pain as tolerable or intolerable post-operatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18+
- Undergoing ACL reconstruction surgery at Stanford Sports Medicine Redwood City, with autograft or allograft, with or without concomitant meniscal repair.
Key exclusion criteria (4 listed)
- Pregnant women
- Surgical history of the operated knee
- Known allergy to opioid medications
- Received extra-routine pain care (as compared with the average ACL patients at the Sports Medicine division) given by the anesthesiologists, such as the postoperative epidural analgesia or the ultra-sound guided femoral nerve block.
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 |
|---|---|---|
| Binary pain questionnairePost-operative questionnaire that asks if pain is 'tolerable' or 'intolerable' | Other | Binary pain questionnaire |
| Numerical Pain Rating Scale (NPRS)Standard 10-point pain scale used post-operatively to assess pain | Other | 10-point pain scale |
Primary outcome
Amount of opioid medication used post-operatively for 14 days
Time frame: 14 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- 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.
Todd Alamin, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binary pain questionnaire and Numerical Pain Rating Scale (NPRS) in people with Anterior Cruciate Ligament (ACL) Reconstruction and Anterior Cruciate Ligament/Surgery, run by Stanford University at 1 site in United States.
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 4 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: enrolling by invitation, as of the sponsor's last update on 15 Jun 2026. 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 United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Amount of opioid medication used post-operatively for 14 days (time frame: 14 days post-surgery). 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 15 Jun 2026.