Total Knee ArthroplastyEarly Phase 1NCT02991404
Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty
A Early Phase 1 study testing Multimodal Peripheral Nerve Block Injection, Single Shot Adductor Canal Block and Initial Bolus in people with Total Knee Arthroplasty and Pain, Postoperative, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Patients undergoing Primary Total Knee Arthroplasty will be randomized to receive either multimodal single injection adductor canal block with sham infusion catheter or continuous infusion of local anesthetic (control) for postoperative analgesia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Total Knee Arthroplasty, Pain, Postoperative, Adductor Canal Block
- What is being tested?
- Multimodal Peripheral Nerve Block Injection, Single Shot Adductor Canal Block and Initial Bolus
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to 15 Nov 2017
- Phase
- Early Phase 1
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible for inclusion in the study if they are:
- Age of 18 years old or older
- Scheduled to primary unilateral total knee arthroplasty.
- Patients must give written informed consent for anesthesia including continuous adductor canal block for postoperative analgesia prior to recruitment
Who cannot join
- Patients will be excluded if they have:
- A contraindication to an adductor canal block or catheter placement including, but not limited to site infection, irritation, or refusal.
- Poorly controlled diabetes (A1C >8.0)
- Allergy to medications involves in this study (opioids, bupivacaine, buprenorphine, clonidine, or dexamethasone)
- Opioid use >40 mg of oxycodone daily, long-acting opioids.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Hospital
Winston-Salem, North Carolina, 27157
About this study
Patients undergoing Primary Total Knee Arthroplasty will be randomized to receive either multimodal single injection adductor canal block with sham infusion catheter or continuous infusion of local anesthetic (control) for postoperative analgesia.
Primary end point is pain scores at 30 hours post performance of block procedure.
Read the detailed description
The objective of this study is to determine if a single shot multimodal peripheral nerve block containing bupivacaine, dexamethasone, buprenorphine, clonidine, and epinephrine will provide comparable (equivalent) analgesic control when compared to an adductor catheter. The primary end point will be pain scores at 30 hours post block initiation. Secondary end points will include, opioid consumption, time to first analgesic request; pain scores; binary patient satisfaction (yes/no); likeliness to recommend their analgesic regimen, straight leg raise test on post-operative day (POD) number 1; adverse events, incidence of post-operative nausea, and vomiting.
Methods and Measures Design The study will be a randomized, double-blind, sham catheter study. Patients will be recruited and randomized to one of two groups: The "Treatment Arm" receive a single shot adductor canal block containing 20 milliliters (ml) of solution including 0.25% bupivacaine, 150 mcg of buprenorphine, 2 mg of dexamethasone, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine with sham catheter. The sham catheter will be placed in the Sartorius muscle in the same sterile, aseptic fashion as patient's in the control arm. The pump will be set at the lowest possible volume per hour of normal saline (0.1 ml/hour in the current pump in use at our hospital). An opaque bag will be placed over the pump for blinding purposes. The "Control Arm" will receive an adductor canal catheter through which they will receive a 20 ml bolus of 0.25% bupivacaine with 1:400,000 epinephrine followed by an adductor canal catheter infusion of 0.125% bupivacaine at 10 ml/hour. An opaque bag will be placed over the control arm pumps in similar fashion. For all patients, the order in the electronic medical record will be per research pharmacy protocol. For their primary anesthetic, patients in both arms will then receive either a subarachnoid (spinal) anesthetic or general anesthetic per the anesthesiologist in the operating room.
- Being tested
- Multimodal Peripheral Nerve Block Injection, Single Shot Adductor Canal Block, Initial Bolus, Continuous infusion
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Peripheral Nerve Block InjectionProcedure or surgery
Also called adductor canal catheter bolus and continuous infusion
After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour.
Single Shot Adductor Canal BlockProcedure or surgery
Also called adductor canal block
A total of 20 ml of solution containing a combination of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, 150 micrograms of buprenorphine, 2 mg of dexamethasone, and 1:400,000 epinephrine will be administered underneath the Sartorius muscle. A sham catheter will then be placed subcutaneously into the Sartorius muscle, secured in typical fashion, and connected to a pump containing saline to provide similar shape and weight with an opaque bag covering the pump. The pump will be run at the lowest possible ml/hour rate, which is currently 0.1 ml/hour with the current pump used in our hospital.
Initial BolusDrug
20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine
Continuous infusionDrug
Continuous infusion of 0.125% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Continuous adductor canal block | Active comparator | After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time (Initial bolus) 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour.
Multimodal peripheral nerve block injection. Receives: Procedure: Multimodal Peripheral Nerve Block Injection; Drug: Initial Bolus; Drug: Continuous infusion |
| Single injection block with sham cath | Sham comparator | Single Shot Adductor Canal Block . Patients will receive single injection adductor canal block (Initial Bolus) with bupivacaine 0.25%, epinephrine, clonidine, buprenorphine and dexamethasone. These patients will have a sham infusion catheter of inert saline placed in the same fashion as the other group. Receives: Procedure: Single Shot Adductor Canal Block; Drug: Initial Bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
At 30 hours pain scores between the two groups will be compared for determining statistically significant differences
Measured: 30 hours post block placement
Secondary outcomes (1)
total opioid consumption
The amount of total opioid consumed will be collected
Measured: Through 30 hours post block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start17 Feb 2017
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan D Jaffe, D.O., Principal investigator, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991404
- Sponsor's protocol ID
- IRB00041950
- Status last verified
- Apr 2018
- First submitted
- 8 Dec 2016
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02991404
- Acronym / sponsor ID
- IRB00041950
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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.
Patients undergoing Primary Total Knee Arthroplasty will be randomized to receive either multimodal single injection adductor canal block with sham infusion catheter or continuous infusion of local anesthetic (control) for postoperative analgesia.
Primary end point is pain scores at 30 hours post performance of block procedure.
Detailed description
The objective of this study is to determine if a single shot multimodal peripheral nerve block containing bupivacaine, dexamethasone, buprenorphine, clonidine, and epinephrine will provide comparable (equivalent) analgesic control when compared to an adductor catheter. The primary end point will be pain scores at 30 hours post block initiation. Secondary end points will include, opioid consumption, time to first analgesic request; pain scores; binary patient satisfaction (yes/no); likeliness to recommend their analgesic regimen, straight leg raise test on post-operative day (POD) number 1; adverse events, incidence of post-operative nausea, and vomiting.
Methods and Measures Design The study will be a randomized, double-blind, sham catheter study. Patients will be recruited and randomized to one of two groups: The "Treatment Arm" receive a single shot adductor canal block containing 20 milliliters (ml) of solution including 0.25% bupivacaine, 150 mcg of buprenorphine, 2 mg of dexamethasone, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine with sham catheter. The sham catheter will be placed in the Sartorius muscle in the same sterile, aseptic fashion as patient's in the control arm. The pump will be set at the lowest possible volume per hour of normal saline (0.1 ml/hour in the current pump in use at our hospital). An opaque bag will be placed over the pump for blinding purposes. The "Control Arm" will receive an adductor canal catheter through which they will receive a 20 ml bolus of 0.25% bupivacaine with 1:400,000 epinephrine followed by an adductor canal catheter infusion of 0.125% bupivacaine at 10 ml/hour. An opaque bag will be placed over the control arm pumps in similar fashion. For all patients, the order in the electronic medical record will be per research pharmacy protocol. For their primary anesthetic, patients in both arms will then receive either a subarachnoid (spinal) anesthetic or general anesthetic per the anesthesiologist in the operating room.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous adductor canal block | Active comparator | Procedure: Multimodal Peripheral Nerve Block Injection, Drug: Initial Bolus, Drug: Continuous infusionAfter successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time (Initial bolus) 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour. Multimodal peripheral nerve block injection. |
| Single injection block with sham cath | Sham comparator | Procedure: Single Shot Adductor Canal Block, Drug: Initial BolusSingle Shot Adductor Canal Block . Patients will receive single injection adductor canal block (Initial Bolus) with bupivacaine 0.25%, epinephrine, clonidine, buprenorphine and dexamethasone. These patients will have a sham infusion catheter of inert saline placed in the same fashion as the other group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 18 years old or older
- Scheduled to primary unilateral total knee arthroplasty.
- Patients must give written informed consent for anesthesia including continuous adductor canal block for postoperative analgesia prior to recruitment
Key exclusion criteria (5 listed)
- A contraindication to an adductor canal block or catheter placement including, but not limited to site infection, irritation, or refusal.
- Poorly controlled diabetes (A1C >8.0)
- Allergy to medications involves in this study (opioids, bupivacaine, buprenorphine, clonidine, or dexamethasone)
- Opioid use >40 mg of oxycodone daily, long-acting opioids.
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 |
|---|---|---|
| Multimodal Peripheral Nerve Block InjectionAlso: adductor canal catheter bolus and continuous infusionAfter successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour. | Procedure or surgery | Continuous adductor canal block |
| Single Shot Adductor Canal BlockAlso: adductor canal blockA total of 20 ml of solution containing a combination of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, 150 micrograms of buprenorphine, 2 mg of dexamethasone, and 1:400,000 epinephrine will be administered underneath the Sartorius muscle. A sham catheter will then be placed subcutaneously into the Sartorius muscle, secured in typical fashion, and connected to a pump containing saline to provide similar shape and weight with an opaque bag covering the pump. The pump will be run at the lowest possible ml/hour rate, which is currently 0.1 ml/hour with the current pump used in our hospital. | Procedure or surgery | Single injection block with sham cath |
| Initial Bolus20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine | Drug | Continuous adductor canal block, Single injection block with sham cath |
| Continuous infusionContinuous infusion of 0.125% bupivacaine | Drug | Continuous adductor canal block |
Primary outcome
Pain scores
Time frame: 30 hours post block placement
At 30 hours pain scores between the two groups will be compared for determining statistically significant differences
1 secondary outcome
total opioid consumption
Time frame: Through 30 hours post block
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 5 Apr 2018.
- 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.
Jonathan D Jaffe, D.O. principal investigator
Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Multimodal Peripheral Nerve Block Injection, Single Shot Adductor Canal Block and Initial Bolus in people with Total Knee Arthroplasty and Pain, Postoperative, run by Wake Forest University Health Sciences 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 5 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 5 Apr 2018. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 scores (time frame: 30 hours post block placement). 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 5 Apr 2018.