Acute Postoperative PainPhase 4NCT06784882
Continuous Versus Single Injection Adductor Canal Blocks for Outpatient Total Knee Arthroplasty
A Phase 4 study testing continuous peripheral nerve block with OnQ pump and single injection nerve block in people with Acute Postoperative Pain and Surgery, run by University of California, San Diego at 1 site in United States.
Trial summary
This is a single-center pilot study to determine if an adductor canal continuous nerve block is superior to single injection nerve block following total knee arthroplasty. Investigators will randomize participants to either continuous nerve block or single injection nerve block for the adductor canal preoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Postoperative Pain, Surgery
- What is being tested?
- continuous peripheral nerve block with OnQ pump and single injection nerve block
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 Dec 2025
- Phase
- Phase 4
- 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
- Adult participants of at least 18 years of age
- Undergoing a primary, unilateral, total knee arthroplasty
- Planned single-injection adductor canal nerve block
- Weight > 50 kg (to minimize the risk of local anesthetic toxicity)
Who cannot join
- chronic opioid or tramadol use: daily oxycodone equivalents > 20 mg for > 4 weeks
- neuro-muscular deficit of the surgical limb
- moderate pain (NRS > 3) in an anatomic location other than the surgical site
- planned hospital admission following surgery
- history of opioid misuse
- those who lack capacity to complete informed consent
Show all 10Show fewer
- inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access)
- incarceration
- pregnancy
- allergy to amide local anesthetics
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, 1 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 92037
Rodney Gabriel, 8586637747, ragabriel@health.ucsd.edu
About this study
Official title: A Pilot Randomized Controlled Trial Assessing Pain and Opioid Outcomes Among Patients Undergoing Total Knee Arthroplasty Receiving 5-Day Outpatient Adductor Canal Continuous Versus Single Injection Blocks
This is a single-center pilot study to determine if an adductor canal continuous nerve block is superior to single injection nerve block following total knee arthroplasty. Investigators will randomize participants to either continuous nerve block or single injection nerve block for the adductor canal preoperatively. They will assess differences in pain (measured in numeric rating scale), opioid consumption, and physical therapy milestones from postoperative day 0 to 7.
Read the detailed description
Adductor canal blocks are standard care for postoperative analgesia following total knee arthroplasty. Adductor canal blocks involve depositing local anesthetic (ropivacaine) around the saphenous nerve at the location of the adductor canal on the ipsilateral thigh. At UCSD, the standard care is to perform single injection adductor canal blocks for research participants undergoing total knee arthroplasty prior to surgery in the preoperative waiting area.
Participants will be randomized to either: (1) single injection with ropivacaine (0.5%) of the adductor canal block AND a 5-day continuous perineural infusion of ropivacaine (0.2%) (experimental group); versus (2) single injection with ropivacaine (0.5%) of the adductor canal block and no continuous nerve block added.
- Conditions
- Acute Postoperative Pain, Surgery
- Being tested
- continuous peripheral nerve block with OnQ pump, single injection nerve block
- Keywords
- regional anesthesia, total knee arthroplasty, nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous peripheral nerve block with OnQ pumpDevice
For continuous nerve blocks, the infusion pump that will be used are OnQ pumps (Avanos, Alpharetta, GA) and pre-filled with ropivacaine 0.2% and provided by UCSD's Investigational Drug Services.
single injection nerve blockDrug
An adductor canal single injection nerve block will be performed per standard of care. The adductor canal will be identified by ultrasound in the short-axis view. The distal aspect of the femoral triangle (and beginning of the adductor canal) will be identified distal to the mid-thigh in the ipsilateral limb. Using ultrasound guidance, a standard Tuohy block needle will be advanced through a skin wheal of lidocaine until its tip is in the hypoechoic area immediately distal saphenous nerve adjacent to the femoral artery. Twenty milliliters of ropivacaine 0.5% will be injected in divided doses with repeated negative aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Continuous adductor canal block | Experimental | single injection with ropivacaine (0.5%) of the adductor canal block and a 5-day continuous perineural infusion of ropivacaine (0.2%) (experimental group) Receives: Device: continuous peripheral nerve block with OnQ pump |
| single injection adductor canal block | Active comparator | single injection with ropivacaine (0.5%) of the adductor canal block and no continuous nerve block added Receives: Drug: single injection nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic effect of 5-day continuous nerve block of the adductor canal relative to a single inection nerve block with ropivacaine.
Numeric Rating Scale (NRS) for pain will be superior daily with continuous adductor canal blocks on postoperative days 1-7 following total ankle arthroplasty as compared with single-injection adductor canal blocks (as measured by the "average" daily NRS within the Brief Pain Inventory)
Measured: 7 days
opioid consumption of 5-day continuous nerve block of the adductor canal relative to a single inection nerve block with ropivacaine.
Opioid consumption will be superior daily with continuous adductor canal blocks on postoperative days 1-7 following total ankle arthroplasty as compared with single-injection adductor canal blocks (measured in oxycodone equivalents)
Measured: 7 days
Secondary outcomes (4)
physical and emotional functioning of 5-day continuous nerve blocks relative to a single injection nerve blocks with ropivacaine
The physical and emotional functioning of research participants will be superior daily with continuous adductor canal blocks on postoperative days 1-7 following total ankle arthroplasty as compared with single-injection adductor canal blocks (as measured with the Brief Pain Inventory Interference Subscale)
Measured: 7 days
improvement in physical therapy milestones of 5-day continuous nerve blocks relative to a single injection nerve blocks with ropivacaine
Knee injury and osteoarthritis outcome score for joint replacement (KOOS JR)
Measured: 30 days
30-day pain score measured in Numeric Rating Scale
At around 30 days postoperatively, the patients average pain score measured in the numeric rating scale (0-10) will be assessed.
Measured: 30 days
30-day postoperative opioid consumption
Around 30 days postoperatively, the average opioid consumption will be assessed. This will be based on the average opioid consumption over the preceding week at 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Jun 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodney Gabriel, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784882
- Sponsor's protocol ID
- 811228
- Status last verified
- Jun 2025
- First submitted
- 11 Jan 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
PubMed 26827847
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial Assessing Pain and Opioid Outcomes Among Patients Undergoing Total Knee Arthroplasty Receiving 5-Day Outpatient Adductor Canal Continuous Versus Single Injection Blocks
- ClinicalTrials.gov ID
- NCT06784882
- Acronym / sponsor ID
- 811228
- Conditions
- Acute Postoperative Pain, Surgery
- Keywords
- regional anesthesia, total knee arthroplasty, nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Jan 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.
This is a single-center pilot study to determine if an adductor canal continuous nerve block is superior to single injection nerve block following total knee arthroplasty. Investigators will randomize participants to either continuous nerve block or single injection nerve block for the adductor canal preoperatively. They will assess differences in pain (measured in numeric rating scale), opioid consumption, and physical therapy milestones from postoperative day 0 to 7.
Detailed description
Adductor canal blocks are standard care for postoperative analgesia following total knee arthroplasty. Adductor canal blocks involve depositing local anesthetic (ropivacaine) around the saphenous nerve at the location of the adductor canal on the ipsilateral thigh. At UCSD, the standard care is to perform single injection adductor canal blocks for research participants undergoing total knee arthroplasty prior to surgery in the preoperative waiting area.
Participants will be randomized to either: (1) single injection with ropivacaine (0.5%) of the adductor canal block AND a 5-day continuous perineural infusion of ropivacaine (0.2%) (experimental group); versus (2) single injection with ropivacaine (0.5%) of the adductor canal block and no continuous nerve block added.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous adductor canal block | Experimental | Device: continuous peripheral nerve block with OnQ pumpsingle injection with ropivacaine (0.5%) of the adductor canal block and a 5-day continuous perineural infusion of ropivacaine (0.2%) (experimental group) |
| single injection adductor canal block | Active comparator | Drug: single injection nerve blocksingle injection with ropivacaine (0.5%) of the adductor canal block and no continuous nerve block added |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult participants of at least 18 years of age
- Undergoing a primary, unilateral, total knee arthroplasty
- Planned single-injection adductor canal nerve block
- Weight > 50 kg (to minimize the risk of local anesthetic toxicity)
Key exclusion criteria (10 listed)
- chronic opioid or tramadol use: daily oxycodone equivalents > 20 mg for > 4 weeks
- neuro-muscular deficit of the surgical limb
- moderate pain (NRS > 3) in an anatomic location other than the surgical site
- planned hospital admission following surgery
- history of opioid misuse
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 |
|---|---|---|
| continuous peripheral nerve block with OnQ pumpFor continuous nerve blocks, the infusion pump that will be used are OnQ pumps (Avanos, Alpharetta, GA) and pre-filled with ropivacaine 0.2% and provided by UCSD's Investigational Drug Services. | Device | Continuous adductor canal block |
| single injection nerve blockAn adductor canal single injection nerve block will be performed per standard of care. The adductor canal will be identified by ultrasound in the short-axis view. The distal aspect of the femoral triangle (and beginning of the adductor canal) will be identified distal to the mid-thigh in the ipsilateral limb. Using ultrasound guidance, a standard Tuohy block needle will be advanced through a skin wheal of lidocaine until its tip is in the hypoechoic area immediately distal saphenous nerve adjacent to the femoral artery. Twenty milliliters of ropivacaine 0.5% will be injected in divided doses with repeated negative aspiration. | Drug | single injection adductor canal block |
Primary outcome
analgesic effect of 5-day continuous nerve block of the adductor canal relative to a single inection nerve block with ropivacaine.
Time frame: 7 days
Numeric Rating Scale (NRS) for pain will be superior daily with continuous adductor canal blocks on postoperative days 1-7 following total ankle arthroplasty as compared with single-injection adductor canal blocks (as measured by the "average" daily NRS within the Brief Pain Inventory)
opioid consumption of 5-day continuous nerve block of the adductor canal relative to a single inection nerve block with ropivacaine.
Time frame: 7 days
Opioid consumption will be superior daily with continuous adductor canal blocks on postoperative days 1-7 following total ankle arthroplasty as compared with single-injection adductor canal blocks (measured in oxycodone equivalents)
4 secondary outcomes
physical and emotional functioning of 5-day continuous nerve blocks relative to a single injection nerve blocks with ropivacaine
Time frame: 7 days
improvement in physical therapy milestones of 5-day continuous nerve blocks relative to a single injection nerve blocks with ropivacaine
Time frame: 30 days
30-day pain score measured in Numeric Rating Scale
Time frame: 30 days
30-day postoperative opioid consumption
Time frame: 30 days
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 17 Jun 2025.
- Background: PubMed 26827847Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing continuous peripheral nerve block with OnQ pump and single injection nerve block in people with Acute Postoperative Pain and Surgery, run by University of California, San Diego 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 Jun 2025. 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.
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?
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?
Contact Rodney A Gabriel, MD (858-663-7747, ragabriel@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesic effect of 5-day continuous nerve block of the adductor canal relative to a single inection nerve block with ropivacaine. (time frame: 7 days). 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 NCT06784882, which also lists 1 linked publication.
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 17 Jun 2025.