Orthopedic DisordersNCT02563990
Injection Pressure & Adductor Canal Block
A study testing High Pressure Injection and Low Pressure Injection in people with Orthopedic Disorders and Injury of Anterior Cruciate Ligament, run by University of Miami at 1 site in United States.
Trial summary
This is a prospective, randomized, single-blinded human clinical trial that will examine how injection pressure influences the spread of a given volume of injectate in the adductor canal, during adductor canal nerve block. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Disorders, Injury of Anterior Cruciate Ligament
- What is being tested?
- High Pressure Injection and Low Pressure Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2015to 9 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Planned general anesthetic.
- American Society of Anesthesia classes I, II, or III.
- Patients aged 18-65.
- English-speaking patients.
Who cannot join
- ASA classes IV and V.
- Patients younger than 18 or older than 65.
- Contraindication to regional anesthesia (coagulopathy, patient refusal).
- Allergy to local anesthetic or other study medications.
- BMI > 35 kg/m2.
- Chronic opioid use (daily or almost daily use for > 3 months).
Show all 12Show fewer
- Active illicit drug use.
- Additional surgical site other than the limb for adductor canal block.
- Pregnancy.
- Preexisting neuropathy in the operative limb.
- Inability to communicate to investigators or hospital staff.
- Inability to speak or understand English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Injection Pressure During Adductor Canal Nerve Block
This is a prospective, randomized, single-blinded human clinical trial that will examine how injection pressure influences the spread of a given volume of injectate in the adductor canal, during adductor canal nerve block.
Read the detailed description
This is a prospective, randomized, single-blinded human clinical trial that will examine how injection pressure influences the spread of a given volume of injectate in the adductor canal, during adductor canal nerve block. The study population will be patients undergoing elective anterior cruciate ligament repair in the distal lower extremity and receiving preoperative adductor canal nerve blocks for postoperative analgesia. They will be randomized into two groups of 25 patients each. The investigators speculate that high injection pressures (>20 psi) will lead to greater spread of local anesthetic than low injection pressures (<15 psi) during mid-thigh adductor canal nerve blocks. The primary endpoint is the spread of injectate, defined as the distance between the uppermost and lowermost limits of spread of local anesthetic as assessed by ultrasound. The secondary endpoints are the incidence of femoral and sciatic nerve blocks 30 minutes after block placement, amount of IV opioid administered intraoperatively and postoperatively, preoperative and postoperative pain (Numeric Rating Scale, 0-10), and postoperative physical therapy milestone achievement.
- Being tested
- High Pressure Injection, Low Pressure Injection
- Medical subject headings
- Musculoskeletal Diseases, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Pressure InjectionProcedure or surgery
Adductor canal block performed at greater than 20 psi injection pressure
Low Pressure InjectionProcedure or surgery
Adductor canal block performed at less than 15 psi injection pressure
| Study group | Role | What they receive |
|---|---|---|
| High Pressure | Experimental | High pressure injection of Ropivacaine local anesthetic at greater than 20 psi Receives: Procedure: High Pressure Injection |
| Low Pressure | Active comparator | Low pressure injection of Ropivacaine local anesthetic at less than 15 psi Receives: Procedure: Low Pressure Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spread of Injectate
Our primary endpoint is the spread of injectate, defined as the distance between the uppermost and lowermost limits of spread of local anesthetic as assessed by ultrasound.
Measured: Immediate post-procedure on day 1
Secondary outcomes (8)
Number of Events of Femoral Nerve Block 30 Minutes After Block Placement
Sensory testing will use a pinprick method in the femoral (anterior thigh), saphenous (medial calf proximal to the medial malleolus, top of the patella) and sciatic (posterolateral calf, plantar surface of the foot) nerve distributions; if patients are unable to feel the stimulus in the femoral nerve distribution, then an outcome of a femoral nerve block will be recorded.
Measured: post-procedure and postoperative on day 1
Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement
Sensory testing will use a pinprick method in the femoral (anterior thigh), saphenous (medial calf proximal to the medial malleolus, top of the patella) and sciatic (posterolateral calf, plantar surface of the foot) nerve distributions; if patients are unable to feel the stimulus in the sciatic nerve distribution, then an outcome of a sciatic nerve block will be recorded.
Measured: post-procedure and postoperative on day 1
Postoperative Pain Scores (Numeric Rating Scale, 0-10)
Patients will rate their pain after surgery on a scale from 0-10, with 0 being no pain, and 10 being the worst pain of their life.
Measured: postoperative on day 1
Postoperative Physical Therapy Milestone Achievement
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Measured: postoperative week 1
Postoperative Physical Therapy Milestone Achievement
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Measured: postoperative week 2
Postoperative Physical Therapy Milestone Achievement
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Measured: postoperative week 3
Postoperative Physical Therapy Milestone Achievement
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Measured: postoperative week 4
Opioid Administration
Intraoperative and immediate postoperative opioid administration. Calculated as morphine milliequivalent (in milligrams).
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study start3 Dec 2015
- Primary completion9 Nov 2016
- Study completion9 Dec 2016
Why it stopped: Unable to recruit additional patients due to transfer of surgical service (ortho sports medicine) and recruitable cases to another institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Orthopedic DisordersStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres Missair, University of Miami
- Investigators
- Andres Missair, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563990
- Sponsor's protocol ID
- 20150583
- Status last verified
- Jan 2020
- First submitted
- 25 Sep 2015
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Injection Pressure During Adductor Canal Nerve Block
- ClinicalTrials.gov ID
- NCT02563990
- Acronym / sponsor ID
- 20150583
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit additional patients due to transfer of surgical service (ortho sports medicine) and recruitable cases to another institution.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 3 Dec 2015 (actual)
- Primary completion
- 9 Nov 2016 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Posted 13 Jan 2020
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 prospective, randomized, single-blinded human clinical trial that will examine how injection pressure influences the spread of a given volume of injectate in the adductor canal, during adductor canal nerve block.
Detailed description
This is a prospective, randomized, single-blinded human clinical trial that will examine how injection pressure influences the spread of a given volume of injectate in the adductor canal, during adductor canal nerve block. The study population will be patients undergoing elective anterior cruciate ligament repair in the distal lower extremity and receiving preoperative adductor canal nerve blocks for postoperative analgesia. They will be randomized into two groups of 25 patients each. The investigators speculate that high injection pressures (>20 psi) will lead to greater spread of local anesthetic than low injection pressures (<15 psi) during mid-thigh adductor canal nerve blocks. The primary endpoint is the spread of injectate, defined as the distance between the uppermost and lowermost limits of spread of local anesthetic as assessed by ultrasound. The secondary endpoints are the incidence of femoral and sciatic nerve blocks 30 minutes after block placement, amount of IV opioid administered intraoperatively and postoperatively, preoperative and postoperative pain (Numeric Rating Scale, 0-10), and postoperative physical therapy milestone achievement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Pressure | Experimental | Procedure: High Pressure InjectionHigh pressure injection of Ropivacaine local anesthetic at greater than 20 psi |
| Low Pressure | Active comparator | Procedure: Low Pressure InjectionLow pressure injection of Ropivacaine local anesthetic at less than 15 psi |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned general anesthetic.
- American Society of Anesthesia classes I, II, or III.
- Patients aged 18-65.
- English-speaking patients.
Key exclusion criteria (12 listed)
- ASA classes IV and V.
- Patients younger than 18 or older than 65.
- Contraindication to regional anesthesia (coagulopathy, patient refusal).
- Allergy to local anesthetic or other study medications.
- BMI > 35 kg/m2.
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 |
|---|---|---|
| High Pressure InjectionAdductor canal block performed at greater than 20 psi injection pressure | Procedure or surgery | High Pressure |
| Low Pressure InjectionAdductor canal block performed at less than 15 psi injection pressure | Procedure or surgery | Low Pressure |
Primary outcome
Spread of Injectate
Time frame: Immediate post-procedure on day 1
Our primary endpoint is the spread of injectate, defined as the distance between the uppermost and lowermost limits of spread of local anesthetic as assessed by ultrasound.
8 secondary outcomes
Number of Events of Femoral Nerve Block 30 Minutes After Block Placement
Time frame: post-procedure and postoperative on day 1
Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement
Time frame: post-procedure and postoperative on day 1
Postoperative Pain Scores (Numeric Rating Scale, 0-10)
Time frame: postoperative on day 1
Postoperative Physical Therapy Milestone Achievement
Time frame: postoperative week 1
Postoperative Physical Therapy Milestone Achievement
Time frame: postoperative week 2
Postoperative Physical Therapy Milestone Achievement
Time frame: postoperative week 3
Postoperative Physical Therapy Milestone Achievement
Time frame: postoperative week 4
Opioid Administration
Time frame: day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Andres Missair, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Pressure Injection and Low Pressure Injection in people with Orthopedic Disorders and Injury of Anterior Cruciate Ligament, run by University of Miami 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 12 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: stopped early, as of the sponsor's last update on 13 Jan 2020. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Spread of Injectate (time frame: Immediate post-procedure on day 1). 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 13 Jan 2020.