Pain, PostoperativeNCT03208478
Pain Control for Anterior Cruciate Ligament Reconstruction Patients With Adductor Canal or Femoral Perineural Infusions
A study testing Adductor Canal perineural catheter placement, Femoral Nerve perineural catheter placement and Nimbus pump (Infutronix) in people with Pain, Postoperative and Anterior Cruciate Ligament Injury, run by Stanford University at 1 site in United States.
Trial summary
Nerve blocks are used to provide pain control after moderately painful orthopedic surgeries. Anterior Cruciate Ligament (ACL) reconstruction with patellar autograft is a painful orthopedic procedure performed after traumatic injury to the knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Anterior Cruciate Ligament Injury
- What is being tested?
- Adductor Canal perineural catheter placement, Femoral Nerve perineural catheter placement and Nimbus pump (Infutronix)
- Type of treatment
- Injection or infusion, Medical device, 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
- 18 Jun 2018to 30 Apr 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients >18 years
- ASA physical status I, II, or III
- Scheduled for ACL reconstruction surgery with patellar autograft
Who cannot join
- Pregnancy
- Incarceration
- Age <18
- BMI >35
- Pre-operative opioid use >15 mg morphine equivalents per day
- Inability to communicate with investigators by telephone
- Pre-existing neuropathy of the operative extremity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Comparison of Pain and Quality of Recovery in Patients Undergoing Anterior Cruciate Ligament Reconstruction With Adductor Canal or Femoral Perineural Infusions
Nerve blocks are used to provide pain control after moderately painful orthopedic surgeries. Anterior Cruciate Ligament (ACL) reconstruction with patellar autograft is a painful orthopedic procedure performed after traumatic injury to the knee. Many patients undergoing ACL reconstruction receive a nerve block as part of their anesthetic care. These blocks can be performed in different locations along the femoral nerve, with advantages and disadvantages to each location. Recently published evidence indicates that there is no short-term difference in pain control between the two commonly-targeted locations ("Adductor Canal" and "Femoral"). However, studies involving patients undergoing total knee arthroplasty indicate that femoral blocks provide better pain control with movement than adductor canal blocks. As many patients undergoing ACL reconstruction use continuous passive motion (CPM) machines as part of rehabilitation starting on post-operative day one, the investigators hypothesize that pain control and quality of recovery in the first 48 hours after surgery will be superior with a continuous femoral block than with a continuous adductor canal block. The investigators plan to study this by randomizing patients presenting for ACL reconstruction to receive either a continuous femoral or continuous adductor canal block (both considered adequate means of pain control), and following them to 48 hours to determine the level of pain, quality of recovery score, opioid use, and CPM compliance.
Read the detailed description
covery score, opioid use, and CPM compliance.
- Being tested
- Adductor Canal perineural catheter placement, Femoral Nerve perineural catheter placement, Nimbus pump (Infutronix)
- Medical subject headings
- Pain, Postoperative, 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 perineural catheter placementProcedure or surgery
Also called Adductor Canal block
Patients will receive an Adductor Canal Block intervention for pain control following ACL reconstructive surgeries.
Femoral Nerve perineural catheter placementProcedure or surgery
Also called Femoral Nerve Block
Patients will have a Femoral perineural catheter placed for pain control following ACL reconstructive surgery.
Nimbus pump (Infutronix)Device
This is a FDA approved infusion device that is used in standard of care to store pain medication and to provide patients with continuous pain control medication at a set rate. This pump will be used for both the Adductor Canal and Femoral Nerve block participants.
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal Nerve Block group | Active comparator | Adductor Canal perineural catheter placement. Adductor Canal continuous perineural infusion. Ropivacaine 0.2% will be administered at a continuous rate of 5 mL/hour through a perineural catheter placed in the adductor canal. A Nimbus pump (Infutronix) will be delivering the medication. Receives: Procedure: Adductor Canal perineural catheter placement; Device: Nimbus pump (Infutronix) |
| Femoral Nerve Block group | Active comparator | Femoral Nerve perineural catheter placement. Femoral continuous perineural infusion. Ropivacaine 0.2% will be administered at a continuous rate of 5 mL/hour through a perineural catheter placed near the femoral nerve. A Nimbus pump (Infutronix) will be delivering the medication. Receives: Procedure: Femoral Nerve perineural catheter placement; Device: Nimbus pump (Infutronix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Participants will report pain on a numeric rating scale
Measured: Post-operative day 2
Secondary outcomes (3)
Quality of Recovery
The Quality of Recovery 15 (QoR 15) is a 15-item questionnaire that is often used to assess how patients are doing in their post-operative course. This survey will be used to assess participants' quality of recovery after ACL reconstructive surgery.
Measured: POD 2
Opioid Use
Total morphine equivalents used through POD 2
Measured: POD 2
CPM compliance
number of hours of reported CPM usage through POD 2
Measured: POD 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start18 Jun 2018
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
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 Pain, PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Louis Horn, Stanford University
- Investigators
- Jean Louis-Horn, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208478
- Sponsor's protocol ID
- 41970
- Status last verified
- Jul 2023
- First submitted
- 27 Jun 2017
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen JC, Denoue CF, Horn A, Kasimova K, Vaughn Z, Horn JL. Continuous femoral nerve blocks versus adductor canal blocks for anterior cruciate ligament surgery: a double-blind, superiority randomized controlled trial. Reg Anesth Pain Med. 2026 Jul 21:rapm-2026-107940. doi: 10.1136/rapm-2026-107940. Online ahead of print.
PubMed 42481165
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Pain and Quality of Recovery in Patients Undergoing Anterior Cruciate Ligament Reconstruction With Adductor Canal or Femoral Perineural Infusions
- ClinicalTrials.gov ID
- NCT03208478
- Acronym / sponsor ID
- 41970
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 5 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.
Nerve blocks are used to provide pain control after moderately painful orthopedic surgeries. Anterior Cruciate Ligament (ACL) reconstruction with patellar autograft is a painful orthopedic procedure performed after traumatic injury to the knee. Many patients undergoing ACL reconstruction receive a nerve block as part of their anesthetic care. These blocks can be performed in different locations along the femoral nerve, with advantages and disadvantages to each location. Recently published evidence indicates that there is no short-term difference in pain control between the two commonly-targeted locations ("Adductor Canal" and "Femoral"). However, studies involving patients undergoing total knee arthroplasty indicate that femoral blocks provide better pain control with movement than adductor canal blocks. As many patients undergoing ACL reconstruction use continuous passive motion (CPM) machines as part of rehabilitation starting on post-operative day one, the investigators hypothesize that pain control and quality of recovery in the first 48 hours after surgery will be superior with a continuous femoral block than with a continuous adductor canal block. The investigators plan to study this by randomizing patients presenting for ACL reconstruction to receive either a continuous femoral or continuous adductor canal block (both considered adequate means of pain control), and following them to 48 hours to determine the level of pain, quality of recovery score, opioid use, and CPM compliance.
Detailed description
covery score, opioid use, and CPM compliance.
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 group | Active comparator | Procedure: Adductor Canal perineural catheter placement, Device: Nimbus pump (Infutronix)Adductor Canal perineural catheter placement. Adductor Canal continuous perineural infusion. Ropivacaine 0.2% will be administered at a continuous rate of 5 mL/hour through a perineural catheter placed in the adductor canal. A Nimbus pump (Infutronix) will be delivering the medication. |
| Femoral Nerve Block group | Active comparator | Procedure: Femoral Nerve perineural catheter placement, Device: Nimbus pump (Infutronix)Femoral Nerve perineural catheter placement. Femoral continuous perineural infusion. Ropivacaine 0.2% will be administered at a continuous rate of 5 mL/hour through a perineural catheter placed near the femoral nerve. A Nimbus pump (Infutronix) will be delivering the medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients >18 years
- ASA physical status I, II, or III
- Scheduled for ACL reconstruction surgery with patellar autograft
Key exclusion criteria (7 listed)
- Pregnancy
- Incarceration
- Age <18
- BMI >35
- Pre-operative opioid use >15 mg morphine equivalents per day
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 perineural catheter placementAlso: Adductor Canal blockPatients will receive an Adductor Canal Block intervention for pain control following ACL reconstructive surgeries. | Procedure or surgery | Adductor Canal Nerve Block group |
| Femoral Nerve perineural catheter placementAlso: Femoral Nerve BlockPatients will have a Femoral perineural catheter placed for pain control following ACL reconstructive surgery. | Procedure or surgery | Femoral Nerve Block group |
| Nimbus pump (Infutronix)This is a FDA approved infusion device that is used in standard of care to store pain medication and to provide patients with continuous pain control medication at a set rate. This pump will be used for both the Adductor Canal and Femoral Nerve block participants. | Device | Adductor Canal Nerve Block group, Femoral Nerve Block group |
Primary outcome
Pain Score
Time frame: Post-operative day 2
Participants will report pain on a numeric rating scale
3 secondary outcomes
Quality of Recovery
Time frame: POD 2
Opioid Use
Time frame: POD 2
CPM compliance
Time frame: POD 2
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 24 Jul 2023.
- Derived from this study: PubMed 42481165Chen JC, Denoue CF, Horn A, Kasimova K, Vaughn Z, Horn JL. Continuous femoral nerve blocks versus adductor canal blocks for anterior cruciate ligament surgery: a double-blind, superiority randomized controlled trial. Reg Anesth Pain Med. 2026 Jul 21:rapm-2026-107940. doi: 10.1136/rapm-2026-107940. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Jean Louis-Horn, 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 Adductor Canal perineural catheter placement, Femoral Nerve perineural catheter placement and Nimbus pump (Infutronix) in people with Pain, Postoperative and Anterior Cruciate Ligament Injury, 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 3 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: finished, as of the sponsor's last update on 24 Jul 2023. 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?
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?
Pain Score (time frame: Post-operative day 2). 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 NCT03208478, 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 24 Jul 2023.