Pain, PostoperativePhase 3NCT05161221
Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction
A Phase 3 study testing OxyCODONE 5 mg Oral Tablet, Naproxen 500 Mg and Tylenol Pill in people with Pain, Postoperative and ACL, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Liposomal bupivacaine injectable suspension (Exparel), manufactured by Pacira Pharmaceuticals, is an FDA-approved, long-lasting nonopioid analgesic that is indicated for single-dose infiltration in adults to produce postsurgical local analgesia. Exparel's extended bioavailability allows for 48 hours of pain control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, ACL
- What is being tested?
- OxyCODONE 5 mg Oral Tablet, Naproxen 500 Mg and Tylenol Pill
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to 31 Dec 2022
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing primary anterior cruciate ligament reconstruction with autograft
- Has not used narcotic pain medication in 3 months
- Ages of 18+
- Proficient in the English language
- Willing and able to follow study protocol
Who cannot join
- ACL repair, revision surgery, or allograft
- Multi-ligamentous knee injuries
- Cartilage procedures that prevented adherence to the immediate weightbearing and range of motion rehabilitation protocol
- Patients taking baseline opioid for other injury
- Dementia or other psychiatric illness that would preclude accurate evaluation
- Pregnant or lactating patients
- Non-English speakers as questionnaires are only available in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Adductor Canal Block With Liposomal Bupivacaine (Exparel) Versus Femoral Nerve Catheter for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial
Liposomal bupivacaine injectable suspension (Exparel), manufactured by Pacira Pharmaceuticals, is an FDA-approved, long-lasting nonopioid analgesic that is indicated for single-dose infiltration in adults to produce postsurgical local analgesia. Exparel's extended bioavailability allows for 48 hours of pain control. Periarticular infiltration of liposomal bupivacaine has been safely and effectively used for total knee arthroplasty as an alternative to FNBs, avoiding transient quadriceps weakness and potential in-hospital falls. Recently Exparel has been FDA approved for interscalene brachial plexus nerve block to produce postsurgical regional analgesia for upper extremity/shoulder procedures. It is not yet approved for peripheral nerve blocks of the lower extremity.
No study to date, to our knowledge, has evaluated the efficacy of single-dose adductor canal blockade with Exparel compared to femoral nerve catheter with bupivacaine. We pose that Exparel used for an adductor canal block can offer the benefit of a single-dose injection with extended pain control without the burden of an indwelling catheter and to avoid adverse events of femoral nerve blockade related to quadriceps weakness and dysesthesias.
The purpose of this study is to determine whether adductor canal blockade with liposomal bupivacaine (Exparel) is a safe and effective alternative to femoral nerve catheters for post-operative pain control for patients undergoing ACL reconstruction.
- Conditions
- Pain, Postoperative, ACL
- Being tested
- OxyCODONE 5 mg Oral Tablet, Naproxen 500 Mg, Tylenol Pill, Liposomal bupivacaine, Femoral Nerve Catheter
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxyCODONE 5 mg Oral TabletDrug
Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control
Naproxen 500 MgDrug
Participant will receive Naproxen 500 Mg post surgery for pain control
Tylenol PillDrug
Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control
Liposomal bupivacaineDrug
Also called Exparel
Participants will receive pre-operative adductor canal block with liposomal bupivacaine (Exparel)
Femoral Nerve CatheterProcedure or surgery
Also called Femoral Nerve Block
Participants will receive pre-operative femoral nerve catheter
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative femoral nerve catheter | Active comparator | participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery Receives: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Naproxen 500 Mg; Drug: Tylenol Pill; Procedure: Femoral Nerve Catheter |
| Pre-operative adductor canal block with liposomal bupivacaine | Active comparator | participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel) Receives: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Naproxen 500 Mg; Drug: Tylenol Pill; Drug: Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Participant will record Patient Satisfaction through Visual Analog Scale for pain
Measured: 8 weeks
Post operative pain management
Participant will receive 20 5mg tablets of Oxycodone and will record opioid consumption through post operative instruction sheets from pain control regiments.
Measured: 8 weeks
Post operative pain management
Participant will record quadriceps function tests
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start6 Dec 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161221
- Sponsor's protocol ID
- sham21D.369
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block With Liposomal Bupivacaine (Exparel) Versus Femoral Nerve Catheter for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05161221
- Acronym / sponsor ID
- sham21D.369
- Conditions
- Pain, Postoperative, ACL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 6 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Dec 2021 (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.
Liposomal bupivacaine injectable suspension (Exparel), manufactured by Pacira Pharmaceuticals, is an FDA-approved, long-lasting nonopioid analgesic that is indicated for single-dose infiltration in adults to produce postsurgical local analgesia. Exparel's extended bioavailability allows for 48 hours of pain control. Periarticular infiltration of liposomal bupivacaine has been safely and effectively used for total knee arthroplasty as an alternative to FNBs, avoiding transient quadriceps weakness and potential in-hospital falls. Recently Exparel has been FDA approved for interscalene brachial plexus nerve block to produce postsurgical regional analgesia for upper extremity/shoulder procedures. It is not yet approved for peripheral nerve blocks of the lower extremity.
No study to date, to our knowledge, has evaluated the efficacy of single-dose adductor canal blockade with Exparel compared to femoral nerve catheter with bupivacaine. We pose that Exparel used for an adductor canal block can offer the benefit of a single-dose injection with extended pain control without the burden of an indwelling catheter and to avoid adverse events of femoral nerve blockade related to quadriceps weakness and dysesthesias.
The purpose of this study is to determine whether adductor canal blockade with liposomal bupivacaine (Exparel) is a safe and effective alternative to femoral nerve catheters for post-operative pain control for patients undergoing ACL reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative femoral nerve catheter | Active comparator | Drug: OxyCODONE 5 mg Oral Tablet, Drug: Naproxen 500 Mg, Drug: Tylenol Pill, Procedure: Femoral Nerve Catheterparticipants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery |
| Pre-operative adductor canal block with liposomal bupivacaine | Active comparator | Drug: OxyCODONE 5 mg Oral Tablet, Drug: Naproxen 500 Mg, Drug: Tylenol Pill, Drug: Liposomal bupivacaineparticipants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing primary anterior cruciate ligament reconstruction with autograft
- Has not used narcotic pain medication in 3 months
- Ages of 18+
- Proficient in the English language
- Willing and able to follow study protocol
Key exclusion criteria (7 listed)
- ACL repair, revision surgery, or allograft
- Multi-ligamentous knee injuries
- Cartilage procedures that prevented adherence to the immediate weightbearing and range of motion rehabilitation protocol
- Patients taking baseline opioid for other injury
- Dementia or other psychiatric illness that would preclude accurate evaluation
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 |
|---|---|---|
| OxyCODONE 5 mg Oral TabletParticipants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control | Drug | Pre-operative adductor canal block with liposomal bupivacaine, Pre-operative femoral nerve catheter |
| Naproxen 500 MgParticipant will receive Naproxen 500 Mg post surgery for pain control | Drug | Pre-operative adductor canal block with liposomal bupivacaine, Pre-operative femoral nerve catheter |
| Tylenol PillParticipants will be instructed to take up to 1000mg of Tylenol by mouth for pain control | Drug | Pre-operative adductor canal block with liposomal bupivacaine, Pre-operative femoral nerve catheter |
| Liposomal bupivacaineAlso: ExparelParticipants will receive pre-operative adductor canal block with liposomal bupivacaine (Exparel) | Drug | Pre-operative adductor canal block with liposomal bupivacaine |
| Femoral Nerve CatheterAlso: Femoral Nerve BlockParticipants will receive pre-operative femoral nerve catheter | Procedure or surgery | Pre-operative femoral nerve catheter |
Primary outcome
Patient satisfaction
Time frame: 8 weeks
Participant will record Patient Satisfaction through Visual Analog Scale for pain
Post operative pain management
Time frame: 8 weeks
Participant will receive 20 5mg tablets of Oxycodone and will record opioid consumption through post operative instruction sheets from pain control regiments.
Post operative pain management
Time frame: 8 weeks
Participant will record quadriceps function tests
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
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.
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 Phase 3 study testing OxyCODONE 5 mg Oral Tablet, Naproxen 500 Mg and Tylenol Pill in people with Pain, Postoperative and ACL, run by Rothman Institute Orthopaedics 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 5 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: status not confirmed, as of the sponsor's last update on 17 Dec 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Patient satisfaction (time frame: 8 weeks). The study lists 3 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 17 Dec 2021.