Anterior Cruciate Ligament RuptureNCT03365908
Pain Management of ACL Reconstruction
A study testing Adductor Canal Nerve Block and Ropivacaine injection in people with Anterior Cruciate Ligament Rupture, run by University of California, Davis at 1 site in United States.
Trial summary
This study will compare the outcome of pain interventions that are considered standard of care during the surgical treatment of ACL injuries. The comparison will be looking at pain control during and after ACL surgery as well as functional outcomes in patients that had a nerve block versus those who did not. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Adductor Canal Nerve Block and Ropivacaine injection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18 and 45 years old.
- Clinical and/or advanced imaging confirmation of ACL tear of which reconstructive surgery is recommended and accepted.
Who cannot join
- No prior surgery of the affected and contralateral knee
- Adults unable to consent
- Children (age < 18 years old)
- Prisoners
- Pregnant women
- Inflammatory arthritis
- Non-English-speaking patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pain Management of Anterior Cruciate Ligament Reconstruction: Evaluation of Adductor Canal Block Versus Oral Pain Regimen
This study will compare the outcome of pain interventions that are considered standard of care during the surgical treatment of ACL injuries. The comparison will be looking at pain control during and after ACL surgery as well as functional outcomes in patients that had a nerve block versus those who did not. The investigators hypothesize that pain control will be equal between both groups.
Read the detailed description
Specific Aim #1: To determine if there is a difference in opioid pain medication use following anterior cruciate ligament (ACL) reconstruction between an oral pain regimen versus adductor canal block.
Specific Aim #2: To determine if there is a difference in knee recovery and function post-operatively following ACL reconstruction between an oral pain regimen versus adductor canal block.
Specific Aim #3: To determine if cost-effectiveness or patient flow logistics of ACL reconstruction are affected by whether has patient has adductor canal block versus receiving oral pain medication regimen.
Specific Aim #4: To determine if pre-operative Resiliency scores are associated with post-operative pain and outcomes following ACL reconstruction.
Hypothesis #1: There is no difference in post-operative pain management or functional outcomes following ACL reconstruction based on whether patient had adductor canal block versus an oral pain medication regiment implemented.
Hypothesis #2: Worse resiliency scores pre-operatively are associated with worse outcomes and pain scores post-operatively following ACL reconstruction.
Upon enrollment and at at the participant's pre-op appointment, the participant will complete a questionnaire entitled the Brief Resiliency Scale (BRS) to determine the participant's resiliency score and receive post-operative pain medication prescriptions. At time of surgery the participant will begin a pain diary to chronicle use of pain medication for 6 weeks and turn this document in at the 6-week follow-up appointment along with documentation of time to first able to walk (ambulate) without assistive device (i.e. crutch, walker, etc.). In the recovery room, the participant will verbally complete a Visual Analog Scale to determine the pain level at 15 minutes after surgery and before discharge. At the 3-month post-op visit, the participant will complete another questionnaire entitled the Knee Injury and Osteoarthritis Outcome Score (KOOS) to determine operative knee pain and function. At the 6-month post-op visit, the participant will complete a questionnaire entitled Marx Activity Rating Scale to determine operative knee function.
The treatment will be chosen by chance, like flipping a coin. Neither the participant nor the study doctor will choose what treatment the participant receives. The participant will have a one in two chance of being given each treatment. The participant will know which treatment was given but the operating surgeon will not know.
The participant will be randomized to 1 of 2 standard of care treatment groups at the time of surgery:
- Adductor canal nerve block (an anesthetic block of the femoral nerve halfway down the thigh that causes numbness in the knee and lower part of the leg)), or
- No nerve block for perioperative (during the operation) pain control.
Regardless of treatment group, all participants pre-operatively will receive the following pain medication: 400 mg celecoxib (Celebrex), 300 mg gabapentin (Neurontin), and 1 g of acetaminophen (Tylenol) 1-2 hours before surgery. This oral regimen is similar to standard of care pre-operative medication in total knee arthroplasties (knee replacements).
All participants will also receive the same post-operative prescriptions at their pre-operative clinic visit which will be: 90 tablets of 1 g acetaminophen to be taken three times a day for 30 days and 90 tablets of 5 mg oxycodone with 1-2 tablets to be taken every 4 to 6 hours as needed for pain. Additionally, the participant will receive two medications (Zofran, Phenergan) for nausea/vomiting which are to be taken as needed. Participants will record their medication use.
ACL reconstruction and any other procedures to address any other damage in the participants's knee as determined by the surgeon will be performed as per standard clinical practice at an outpatient surgical facility. The participant will undergo standard post-operative rehabilitation. During the standard of care post-operative visits in the Sports Medicine Clinic, the participant will be asked to fill out questionnaires specific for our data collection.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Adductor Canal Nerve Block, Ropivacaine injection
- Keywords
- ACL
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal Nerve BlockProcedure or surgery
An adductor canal nerve block with 15 mL of 0.5% ropivacaine will be performed pre-operatively by Anesthesiology.
Ropivacaine injectionDrug
15 mL of 0.5% ropivacaine will be administered for the adductor canal block
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal Nerve Block | Experimental | Participant will receive an adductor canal nerve block via 15 mL 0.5% ropivacaine injection prior to OR for ACL reconstruction. Participant will receive pre-op oral medications. Receives: Procedure: Adductor Canal Nerve Block; Drug: Ropivacaine injection |
| No Nerve Block | No intervention | Participant will receive pre-op oral medications but no nerve block prior to OR for ACL reconstruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Post-op Pain Score
Measured via Visual Analog Scale (VAS) in recovery, scale from 0 (least) to 10 (maximum), no units, with 0 being no pain and 10 being extreme pain
Measured: 15 min post-op
Opioid Use
Aggregated amount of narcotic medication used, measured in milligrams
Measured: 6 weeks post-op
Secondary outcomes (4)
Short-term Knee Function Post-op
Functional recovery of knee following surgery as measured by Knee Injury and Osteoarthritis Outcome Score (no units), range from 0 - 100 with 0 representing extreme problems with the knee and 100 representing no problems
Measured: 6 weeks post-op
Intermediate-term Knee Function
Functional recovery of knee following surgery as measured by Marx activity score (no unit), 0 - 16, with 0 representing significant limitation in activity due to knee and 16 representing no limitations
Measured: 12 weeks post-op
Long-term Knee Function
Functional recovery of knee following surgery as measured by Tegner activity score (no units), range from 0 - 10, with 0 representing inability to work or perform daily activities due to knee and 10 representing ability to compete in high-level activities
Measured: 24 weeks post-op
Post-anaesthesia care unit (PACU) Time
Amount of time, measured in minutes, participants required in PACU before discharge due to pain control
Measured: Immediately 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 Dec 2017
- Study start9 Oct 2017
- 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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cassandra Lee, MD, Principal investigator, UC-Davis Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365908
- Sponsor's protocol ID
- 1115203
- Status last verified
- Aug 2026
- First submitted
- 27 Nov 2017
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aronowitz ER, Kleinbart FA. Outpatient ACL reconstruction using intraoperative local analgesia and oral postoperative pain medication. Orthopedics. 1998 Jul;21(7):781-4. doi: 10.3928/0147-7447-19980701-07.
PubMed 9672915Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
PubMed 23241723Abdallah FW, Whelan DB, Chan VW, Prasad GA, Endersby RV, Theodoropolous J, Oldfield S, Oh J, Brull R. Adductor Canal Block Provides Noninferior Analgesia and Superior Quadriceps Strength Compared with Femoral Nerve Block in Anterior Cruciate Ligament Reconstruction. Anesthesiology. 2016 May;124(5):1053-64. doi: 10.1097/ALN.0000000000001045.
PubMed 26938989
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management of Anterior Cruciate Ligament Reconstruction: Evaluation of Adductor Canal Block Versus Oral Pain Regimen
- ClinicalTrials.gov ID
- NCT03365908
- Acronym / sponsor ID
- 1115203
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- ACL
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 7 Dec 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.
This study will compare the outcome of pain interventions that are considered standard of care during the surgical treatment of ACL injuries. The comparison will be looking at pain control during and after ACL surgery as well as functional outcomes in patients that had a nerve block versus those who did not. The investigators hypothesize that pain control will be equal between both groups.
Detailed description
Specific Aim #1: To determine if there is a difference in opioid pain medication use following anterior cruciate ligament (ACL) reconstruction between an oral pain regimen versus adductor canal block.
Specific Aim #2: To determine if there is a difference in knee recovery and function post-operatively following ACL reconstruction between an oral pain regimen versus adductor canal block.
Specific Aim #3: To determine if cost-effectiveness or patient flow logistics of ACL reconstruction are affected by whether has patient has adductor canal block versus receiving oral pain medication regimen.
Specific Aim #4: To determine if pre-operative Resiliency scores are associated with post-operative pain and outcomes following ACL reconstruction.
Hypothesis #1: There is no difference in post-operative pain management or functional outcomes following ACL reconstruction based on whether patient had adductor canal block versus an oral pain medication regiment implemented.
Hypothesis #2: Worse resiliency scores pre-operatively are associated with worse outcomes and pain scores post-operatively following ACL reconstruction.
Upon enrollment and at at the participant's pre-op appointment, the participant will complete a questionnaire entitled the Brief Resiliency Scale (BRS) to determine the participant's resiliency score and receive post-operative pain medication prescriptions. At time of surgery the participant will begin a pain diary to chronicle use of pain medication for 6 weeks and turn this document in at the 6-week follow-up appointment along with documentation of time to first able to walk (ambulate) without assistive device (i.e. crutch, walker, etc.). In the recovery room, the participant will verbally complete a Visual Analog Scale to determine the pain level at 15 minutes after surgery and before discharge. At the 3-month post-op visit, the participant will complete another questionnaire entitled the Knee Injury and Osteoarthritis Outcome Score (KOOS) to determine operative knee pain and function. At the 6-month post-op visit, the participant will complete a questionnaire entitled Marx Activity Rating Scale to determine operative knee function.
The treatment will be chosen by chance, like flipping a coin. Neither the participant nor the study doctor will choose what treatment the participant receives. The participant will have a one in two chance of being given each treatment. The participant will know which treatment was given but the operating surgeon will not know.
The participant will be randomized to 1 of 2 standard of care treatment groups at the time of surgery:
- Adductor canal nerve block (an anesthetic block of the femoral nerve halfway down the thigh that causes numbness in the knee and lower part of the leg)), or
- No nerve block for perioperative (during the operation) pain control.
Regardless of treatment group, all participants pre-operatively will receive the following pain medication: 400 mg celecoxib (Celebrex), 300 mg gabapentin (Neurontin), and 1 g of acetaminophen (Tylenol) 1-2 hours before surgery. This oral regimen is similar to standard of care pre-operative medication in total knee arthroplasties (knee replacements).
All participants will also receive the same post-operative prescriptions at their pre-operative clinic visit which will be: 90 tablets of 1 g acetaminophen to be taken three times a day for 30 days and 90 tablets of 5 mg oxycodone with 1-2 tablets to be taken every 4 to 6 hours as needed for pain. Additionally, the participant will receive two medications (Zofran, Phenergan) for nausea/vomiting which are to be taken as needed. Participants will record their medication use.
ACL reconstruction and any other procedures to address any other damage in the participants's knee as determined by the surgeon will be performed as per standard clinical practice at an outpatient surgical facility. The participant will undergo standard post-operative rehabilitation. During the standard of care post-operative visits in the Sports Medicine Clinic, the participant will be asked to fill out questionnaires specific for our data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Nerve Block | Experimental | Procedure: Adductor Canal Nerve Block, Drug: Ropivacaine injectionParticipant will receive an adductor canal nerve block via 15 mL 0.5% ropivacaine injection prior to OR for ACL reconstruction. Participant will receive pre-op oral medications. |
| No Nerve Block | No intervention | –Participant will receive pre-op oral medications but no nerve block prior to OR for ACL reconstruction. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between the ages of 18 and 45 years old.
- Clinical and/or advanced imaging confirmation of ACL tear of which reconstructive surgery is recommended and accepted.
Key exclusion criteria (7 listed)
- No prior surgery of the affected and contralateral knee
- Adults unable to consent
- Children (age < 18 years old)
- Prisoners
- Pregnant women
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 |
|---|---|---|
| Adductor Canal Nerve BlockAn adductor canal nerve block with 15 mL of 0.5% ropivacaine will be performed pre-operatively by Anesthesiology. | Procedure or surgery | Adductor Canal Nerve Block |
| Ropivacaine injection15 mL of 0.5% ropivacaine will be administered for the adductor canal block | Drug | Adductor Canal Nerve Block |
Primary outcome
Immediate Post-op Pain Score
Time frame: 15 min post-op
Measured via Visual Analog Scale (VAS) in recovery, scale from 0 (least) to 10 (maximum), no units, with 0 being no pain and 10 being extreme pain
Opioid Use
Time frame: 6 weeks post-op
Aggregated amount of narcotic medication used, measured in milligrams
4 secondary outcomes
Short-term Knee Function Post-op
Time frame: 6 weeks post-op
Intermediate-term Knee Function
Time frame: 12 weeks post-op
Long-term Knee Function
Time frame: 24 weeks post-op
Post-anaesthesia care unit (PACU) Time
Time frame: Immediately after 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 18 Aug 2026.
- Background: PubMed 9672915Aronowitz ER, Kleinbart FA. Outpatient ACL reconstruction using intraoperative local analgesia and oral postoperative pain medication. Orthopedics. 1998 Jul;21(7):781-4. doi: 10.3928/0147-7447-19980701-07.
- Background: PubMed 23241723Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
- Background: PubMed 26938989Abdallah FW, Whelan DB, Chan VW, Prasad GA, Endersby RV, Theodoropolous J, Oldfield S, Oh J, Brull R. Adductor Canal Block Provides Noninferior Analgesia and Superior Quadriceps Strength Compared with Femoral Nerve Block in Anterior Cruciate Ligament Reconstruction. Anesthesiology. 2016 May;124(5):1053-64. doi: 10.1097/ALN.0000000000001045.
- Learn more or sign up for the study here!Link provided by the sponsor.
- 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.
Cassandra Lee, MD principal investigator
UC-Davis Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adductor Canal Nerve Block and Ropivacaine injection in people with Anterior Cruciate Ligament Rupture, run by University of California, Davis 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 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: enrolling by invitation, as of the sponsor's last update on 18 Aug 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?
Immediate Post-op Pain Score (time frame: 15 min post-op). The study lists 2 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 NCT03365908, which also lists 3 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 18 Aug 2026.