Pain, JointPhase 3NCT04717609
Saphenous Nerve Block for Partial Meniscectomy
A Phase 3 study testing Saphenous Nerve Block and Ropivacaine injection in people with Pain, Joint and Pain, Procedural, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Partial meniscectomy and meniscus repair are two of the most common orthopedic surgery procedures. As these procedures are being increasingly performed in ambulatory surgical centers, there has been a shift towards providing improved analgesia to ensure timely discharge, as well as preventing unwanted pain and side… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Joint, Pain, Procedural, Meniscectomy
- What is being tested?
- Saphenous Nerve Block and Ropivacaine injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 25 Jan 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
- Age ≥ 18
- Scheduled for arthroscopic meniscectomy or meniscus repair
Who cannot join
- Multiple-ligament injury
- Primary ACL reconstruction or ACL revision reconstruction
- Articular cartilage restoration surgery
- Evidence of microfracture
- History of allergy to local anesthetics
- Pre-existing saphenous neuropathy
- Unable to be prescribed opioids due to allergy or other reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Surgeon Performed Saphenous Nerve Block at the Medial Femoral Condyle for Arthroscopic Partial Meniscectomy and Meniscus Repair: A Randomized Control Trial
Partial meniscectomy and meniscus repair are two of the most common orthopedic surgery procedures. As these procedures are being increasingly performed in ambulatory surgical centers, there has been a shift towards providing improved analgesia to ensure timely discharge, as well as preventing unwanted pain and side effects. As such, it has become common practice to use an intra-articular injection of local anesthetic to achieve post-operative pain control. However, these effects are short lived, requiring a multimodal approach to analgesia. To date, no optimal pain control strategy has been described for arthroscopic partial meniscectomy or meniscus repair. The purpose of this study is to examine the outcomes of subcutaneous saphenous nerve block with 0.5% ropivacaine at the medial femoral epicondyle/adductor hiatus plus portal 0.5% ropivacaine injection vs portal 0.5% ropivacaine injection alone for patients undergoing arthroscopic partial meniscectomy or meniscus repair.
- Conditions
- Pain, Joint, Pain, Procedural, Meniscectomy
- Being tested
- Saphenous Nerve Block, Ropivacaine injection
- Medical subject headings
- Arthralgia, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saphenous Nerve BlockProcedure or surgery
Preoperative Saphenous Nerve Block for partial Meniscectomy
Ropivacaine injectionDrug
preoperatively the participant will receive an injection ar the surgical site of 5 milliliters (mL) of 0.5% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Partial Meniscectomy without Saphenous Nerve Block | Active comparator | Participants scheduled for partial meniscectomy will preoperatively receive 0.5% ropivacaine with epinephrine Receives: Drug: Ropivacaine injection |
| Partial Meniscectomy with Saphenous Nerve Block | Experimental | Participants scheduled for a partial meniscectomy will preoperatively receive a saphenous nerve block at the medial femoral condyle in addition to an injection of 0.5% ropivacaine with epinephrine Receives: Procedure: Saphenous Nerve Block; Drug: Ropivacaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced Pain Levels
This will be measured by Participant Opioid Use will be collected everyday for 10 days after surgery
Measured: 10 days
Quality of Recovery
After surgery while in the recovery room a 40 question survey will be administered regarding your comfort level, emotional state and pain
Measured: 20 minutes
Reduced Pain Levels
This will be measured using the numeric rating score (NRS). It will be collected at 1 and 10 days after surgery
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start25 Jan 2021 (estimated)
- Primary completion25 Jan 2022 (estimated)
- Study completion25 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, JointStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717609
- Sponsor's protocol ID
- JHOR 20D.975
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2021
- Last updated
- 22 Jan 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 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgeon Performed Saphenous Nerve Block at the Medial Femoral Condyle for Arthroscopic Partial Meniscectomy and Meniscus Repair: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04717609
- Acronym / sponsor ID
- JHOR 20D.975
- Conditions
- Pain, Joint, Pain, Procedural, Meniscectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 25 Jan 2021 (estimated)
- Primary completion
- 25 Jan 2022 (estimated)
- Study completion
- 25 Jan 2022 (estimated)
- First posted
- 22 Jan 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.
Partial meniscectomy and meniscus repair are two of the most common orthopedic surgery procedures. As these procedures are being increasingly performed in ambulatory surgical centers, there has been a shift towards providing improved analgesia to ensure timely discharge, as well as preventing unwanted pain and side effects. As such, it has become common practice to use an intra-articular injection of local anesthetic to achieve post-operative pain control. However, these effects are short lived, requiring a multimodal approach to analgesia. To date, no optimal pain control strategy has been described for arthroscopic partial meniscectomy or meniscus repair. The purpose of this study is to examine the outcomes of subcutaneous saphenous nerve block with 0.5% ropivacaine at the medial femoral epicondyle/adductor hiatus plus portal 0.5% ropivacaine injection vs portal 0.5% ropivacaine injection alone for patients undergoing arthroscopic partial meniscectomy or meniscus repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Meniscectomy without Saphenous Nerve Block | Active comparator | Drug: Ropivacaine injectionParticipants scheduled for partial meniscectomy will preoperatively receive 0.5% ropivacaine with epinephrine |
| Partial Meniscectomy with Saphenous Nerve Block | Experimental | Procedure: Saphenous Nerve Block, Drug: Ropivacaine injectionParticipants scheduled for a partial meniscectomy will preoperatively receive a saphenous nerve block at the medial femoral condyle in addition to an injection of 0.5% ropivacaine with epinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18
- Scheduled for arthroscopic meniscectomy or meniscus repair
Key exclusion criteria (7 listed)
- Multiple-ligament injury
- Primary ACL reconstruction or ACL revision reconstruction
- Articular cartilage restoration surgery
- Evidence of microfracture
- History of allergy to local anesthetics
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 |
|---|---|---|
| Saphenous Nerve BlockPreoperative Saphenous Nerve Block for partial Meniscectomy | Procedure or surgery | Partial Meniscectomy with Saphenous Nerve Block |
| Ropivacaine injectionpreoperatively the participant will receive an injection ar the surgical site of 5 milliliters (mL) of 0.5% ropivacaine | Drug | Partial Meniscectomy with Saphenous Nerve Block, Partial Meniscectomy without Saphenous Nerve Block |
Primary outcome
Reduced Pain Levels
Time frame: 10 days
This will be measured by Participant Opioid Use will be collected everyday for 10 days after surgery
Quality of Recovery
Time frame: 20 minutes
After surgery while in the recovery room a 40 question survey will be administered regarding your comfort level, emotional state and pain
Reduced Pain Levels
Time frame: 10 days
This will be measured using the numeric rating score (NRS). It will be collected at 1 and 10 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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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. 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 Saphenous Nerve Block and Ropivacaine injection in people with Pain, Joint and Pain, Procedural, 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 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: status not confirmed, as of the sponsor's last update on 22 Jan 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?
Reduced Pain Levels (time frame: 10 days). 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 22 Jan 2021.