Pain, PostoperativePhase 4FemVsACBNCT02453321
Continuous Adductor Canal Blocks Vs. Low Dose Femoral Nerve Blocks For Early Rehabilitation After Total Knee Arthroplasty
A Phase 4 study testing Continuous Femoral Nerve Block, Nerve Block, Continuous Adductor Canal and Continuous Sciatic Nerve Block in people with Pain, Postoperative and Total Knee Arthroplasty (TKA), run by Kevin King, DO at 1 site in United States.
Trial summary
Recently, several articles have suggested or reported that Adductor Canal Blocks (ACBs) offer adequate or equal analgesia and may promote better performance in early rehabilitation following Total Knee Arthroplasty (TKA) when compared to the more commonly used Femoral Nerve Block (FNB). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Total Knee Arthroplasty (TKA)
- What is being tested?
- Continuous Femoral Nerve Block, Nerve Block, Continuous Adductor Canal and Continuous Sciatic Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 31 Aug 2016
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to consent to regional anesthesia and having primary total knee arthroplasty/replacement
Who cannot join
- Body-Mass Index >40
- Iliac to Patella Distance (IPD) <40cm
- Pre-existing quadriceps weakness of involved surgical side Chronic opioid use (if using opioids within 4 weeks of surgery: excluded)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center - Passavant Hospital
Pittsburgh, Pennsylvania, 15237
About this study
Official title: A Comparison Between Continuous Selective Femoral Blocks and Continuous Adductor Canal Blocks at Mid-Thigh in Total Knee Arthroplasty: What is the Best Method to Optimize Functional Achievement and Analgesia in Early Rehabilitation?
Recently, several articles have suggested or reported that Adductor Canal Blocks (ACBs) offer adequate or equal analgesia and may promote better performance in early rehabilitation following Total Knee Arthroplasty (TKA) when compared to the more commonly used Femoral Nerve Block (FNB). A common feature of these studies has been the use of moderate to high concentration local anesthetics (e.g. 0.2% or 0.5% Ropivacaine respectively) which when injected by a large motor nerve will inevitably cause weakness. However, the practice at our institution has long been a continuous femoral nerve block (CFNB) with a lower concentration local anesthetic (0.0625% Bupivacaine). Over the past several years the investigators have performed several thousand CFNBs using this technique which has offered the advantage of minimal motor weakness and adequate analgesia.
The primary goal of this study is to determine if our established practice of using a low concentration continuous FNB inserted about 5cm caudal to the groin crease (the apex of the femoral triangle) using a low infusion rate of 2ml/hr is comparable to the emerging practice of inserting a Continuous Peripheral Nerve Block (CPNB) in the anatomic adductor canal (AC) - infusing at 4ml/hr. A secondary goal is to study the effect of cumulative volume of local anesthetic infused through a FNB when at a rate of 2ml/hr compared to a rate of 4ml/hr in the 48-hour postoperative period.
Read more
Definitions of the location of the adductor canal are debated heavily in literature, but they seem to agree that the middle 1/3 of the thigh contains the proximal AC while the distal 1/3 of the thigh contains the adductor hiatus - the terminal end of the AC. Our study will require placement of the continuous ACB no more distal than 20cm cephalad to the superior pole of the patella due to placement prior to surgery and the need to keep the dressing out of the operative field. The CACB catheter will also not be placed any more proximal than 20cm distal to the ASIS. In addition to other exclusion criteria, these measurements will create an exclusion for patients with an iliac-to-patella distance less than 40cm. Iliac to Patella distance (IPD) will be measured at the pre-operative interview on the day of surgery with a measuring tape. External palpable landmarks of the Anterior superior iliac spine and the superior pole of the patella will be used.
The primary outcome is based upon the ability to perform rehabilitation exercises postoperatively to the extent that criteria for discharge can be met. The primary outcome measured is the time at which a patient gains the ability to successfully perform a 75-feet unassisted walk. On the Day of Surgery (DOS), prior to any walking attempt, a secondary outcome measure will be to perform a 5-second sustained straight leg raise. Other secondary outcomes will be the number of days admitted prior to discharge, and average pain scores on DOS, Postoperative Day (POD) #1, and POD#2. The Day of discharge will also be used as a secondary outcome. Earlier discharge is becoming a goal of almost all healthcare systems to minimize costs.
Read the detailed description
The three arms are as follows:
- The control group; Continuous Femoral Nerve Block - Low Dose (CFNB-LD) will be patients randomized to our standard therapy comprised of a low dose/concentration Continuous Femoral Nerve Block inserted approximately 5cm distal to the groin crease with a rate of 2ml/hr.
- Higher dose (HD) CFNB; - block placed in same location as CFNB-LD but with a higher dose rate of 4ml/hr. This higher rate could afford more pain control but may cause more quadriceps or hip flexor weakness.
- Continuous Adductor Canal Block (CACB) group will have a catheter inserted 20-30cm proximal to the superior pole of the patella, and an infusion rate of 4ml/hr, but with similar dressing to make it appear like those in group 1 and 2.
Acute Pain/Regional anesthesiologists and fellows will be performing all research procedures in the same locations that the investigators routinely perform regional nerve blocks: our preoperative holding area adjacent to the operating room suites at University of Pittsburgh Medical Center (UPMC) - Passavant.
All three groups have a set rate that will not increase. There also will be no bolus orders given on the floors, however IV and PO medications will be available to decrease discomfort. These medications are ordered to be given upon request (PRN); upon patient request. Down-regulation of doses will also not be allowed as that would cause uncertainty as to which regimen may contribute most to postoperative weakness. The only adjustment allowed will be to turn off the nerve block infusion completely on POD #1 if a dense motor block of the quadriceps or iliopsoas (hip flexor) exists, as this condition does not facilitate participation in rehabilitation exercises. The frequency of early-removal of nerve block will be recorded for all three groups.
CFNB groups Continuous Femoral Nerve Block placement: The skin of the right or left groin will be sterilized and draped under sterile conditions, the femoral nerve will be identified using ultrasound just below the inguinal crease and the local anesthetic will be infiltrated subcutaneously. The needle is inserted at the lateral edge of the probe and directed toward the nerve using ultrasound assistance. When in proximity of the nerve, 15ml of 0.2% ropivacaine will be injected through the needle with repeat aspiration every 5 ml. The nerve block catheter will be placed 3-5 cm past the needle tip and secured with steri strips and bio-occlusive dressing.
CACB group Continuous Adductor Canal Block placement: The distance from the ASIS to the superior pole of the patella will be measured and the distance recorded. This Iliac-to-Patella distance (IPD) will be divided into proximal and distal halves, and the halfway point marked. The length of the IPD will need to be a minimum of 40cm for inclusion. The insertion site will need to be 20cm proximal to the superior pole of the patella and at least 20ml distal to the ASIS. The attending anesthesiologist / acute pain attending either perform or supervise regional anesthesia fellows to place the CACB no more proximal than the halfway mark of the IPD. For example, if a patient has an IPD of 50cm, the halfway mark will be at 25cm and this would be the site of insertion as it would be within the anatomic adductor canal and would be adequately removed from the surgical site. The skin of the right or left anterior-medial thigh will be sterilized and draped under sterile conditions. The sartorius muscle and femoral artery will be identified by an ultrasound at the marked IPD-halfway-mark. There, local anesthetic will be infiltrated subcutaneously. The needle is inserted in the direction of the hyperechoic nerve and the hypoechoic femoral artery using ultrasound assistance. When the needle tip is deep to the sartorius and in proximity of the artery, 15ml of 0.2% ropivacaine will be injected through the needle with repeat aspiration every 5 ml. The nerve catheter will be placed 3-5 cm past the needle tip and secured with steri-strips and bio-occlusive dressing. The CACB rate will be 4ml/hr of bupivacaine 0.0625%.
By design, Observers should only be aware of a singular kind of patient; those with CPNBs.
The dressing of the cACB will be very similar to the CFNB and the standard yellow connector piece will be secured to the skin with bio-occlusive covering, and the location will be at level of the anterior superior iliac spine (ASIS). This standardized dressing will serve to aid in blinding the observers as to which kind of continuous block the patient received. Labeling of the catheter and dressing will not differ. The nerve block billing record will contain the information on the particular approach used.
Sciatic nerve block placement: the corresponding right or left gluteal area will be sterilized and draped under sterile conditions, the sciatic nerve will be identified by an ultrasound in the lower gluteal region where a local anesthetic will be infiltrated subcutaneously. A trans-gluteal approach will be used to inject normal saline through the needle to assist catheter placement; the catheter will be introduced for 3-5 cm past the needle tip and secured with steri strips and tegaderm. No local anesthetic will be administered until the postoperative period.
- Conditions
- Pain, Postoperative, Total Knee Arthroplasty (TKA)
- Being tested
- Continuous Femoral Nerve Block, Nerve Block, Continuous Adductor Canal, Continuous Sciatic Nerve Block, Bupivacaine
- Keywords
- Continuous Femoral Nerve Block, Continuous Adductor Canal Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Femoral Nerve BlockProcedure or surgery
Also called Continuous Nerve Block, Femoral, Continuous Peripheral Nerve Block
A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Nerve Block, Continuous Adductor CanalProcedure or surgery
Also called Continuous Nerve Block, Adductor Canal, Continuous Peripheral Nerve Block, Adductor Canal
A 27g plastic catheter placed on the anterior medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve BlockProcedure or surgery
Also called Nerve Block, Sciatic Continuous
A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
BupivacaineDrug
The concentration of the continuous infusion of bupivacaine though the peripheral nerve catheters will be 0.0625% for the femoral and adductor canal blocks and the concentration for the sciatic continuous catheter will be 0.03%.
| Study group | Role | What they receive |
|---|---|---|
| Cont. Femoral Block - Low Dose Group | Active comparator | Arm is named by the intervention the group receives. Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2. Receives: Procedure: Continuous Femoral Nerve Block; Procedure: Continuous Sciatic Nerve Block; Drug: Bupivacaine |
| Cont. Femoral Block - Higher Dose | Experimental | Place the CPNB in same manner as low-dose group, but rate will be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy Receives: Procedure: Continuous Femoral Nerve Block; Procedure: Continuous Sciatic Nerve Block; Drug: Bupivacaine |
| Continuous Adductor Canal | Experimental | Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups. Receives: Procedure: Nerve Block, Continuous Adductor Canal; Procedure: Continuous Sciatic Nerve Block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Achieve Physical Therapy Discharge Criteria as Measured by 75-feet Walk Test. {Number of Hours After Conclusion of Surgery}
Ability to walk 75 feet if performed on POD#2 is usually considered the main criterion for discharge at UPMC Passavant. The patient is accompanied/supervised by physical therapist using a walker but without active intervention by therapist, unless necessary. The earliest day on which the patient achieves the 75-feet unassisted walk will be recorded for comparison among the arms/groups.
Measured: Participants will be followed for the duration of hospital stay, an average of 4 days
Secondary outcomes (3)
Average Length of Stay (to be Reported in Hours After Surgery)
If pain is controlled and rehabilitation activity is optimal patient may be discharged at an earlier time
Measured: Participants will be followed for the duration of hospital stay; No patients will be discharged on the day of surgery; The earliest discharge would be at 24 hours. Those hospitalized beyond 96 hours will be excluded.
Postoperative Pain, Average Reported Score 11-point Scale
The outcome is measured using a Numeric pain scale. The patient reports their average pain felt on postoperative day one, on a scale of 0 to 10 inclusive. Zero in this case indicates no pain at all and 10 indicates the worst pain they have ever felt.
Measured: postoperative day one
Sustained Straight Leg Raise
Sustained Straight Leg Raise is the ability to elevate the heel and leg/knee off of bed for 5 seconds postoperatively after spinal anesthetic has resolved contralaterally.
Measured: Day of Surgery (DOS) - In Postoperative Recovery Unit, prior to any walking atempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2016
- Study completion31 Aug 2016
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kevin King, DO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kevin King, DO, University of Pittsburgh
- Investigators
- Waters Jonathan, MD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453321
- Sponsor's protocol ID
- PRO13110481
- Acronym
- FemVsACB
- Status last verified
- Feb 2018
- First submitted
- 24 Apr 2015
- Last updated
- 27 Mar 2018
- 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 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Continuous Selective Femoral Blocks and Continuous Adductor Canal Blocks at Mid-Thigh in Total Knee Arthroplasty: What is the Best Method to Optimize Functional Achievement and Analgesia in Early Rehabilitation?
- ClinicalTrials.gov ID
- NCT02453321
- Acronym / sponsor ID
- FemVsACB / PRO13110481
- Conditions
- Pain, Postoperative, Total Knee Arthroplasty (TKA)
- Keywords
- Continuous Femoral Nerve Block, Continuous Adductor Canal Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kevin King, DOUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Posted 27 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently, several articles have suggested or reported that Adductor Canal Blocks (ACBs) offer adequate or equal analgesia and may promote better performance in early rehabilitation following Total Knee Arthroplasty (TKA) when compared to the more commonly used Femoral Nerve Block (FNB). A common feature of these studies has been the use of moderate to high concentration local anesthetics (e.g. 0.2% or 0.5% Ropivacaine respectively) which when injected by a large motor nerve will inevitably cause weakness. However, the practice at our institution has long been a continuous femoral nerve block (CFNB) with a lower concentration local anesthetic (0.0625% Bupivacaine). Over the past several years the investigators have performed several thousand CFNBs using this technique which has offered the advantage of minimal motor weakness and adequate analgesia.
The primary goal of this study is to determine if our established practice of using a low concentration continuous FNB inserted about 5cm caudal to the groin crease (the apex of the femoral triangle) using a low infusion rate of 2ml/hr is comparable to the emerging practice of inserting a Continuous Peripheral Nerve Block (CPNB) in the anatomic adductor canal (AC) - infusing at 4ml/hr. A secondary goal is to study the effect of cumulative volume of local anesthetic infused through a FNB when at a rate of 2ml/hr compared to a rate of 4ml/hr in the 48-hour postoperative period.
Definitions of the location of the adductor canal are debated heavily in literature, but they seem to agree that the middle 1/3 of the thigh contains the proximal AC while the distal 1/3 of the thigh contains the adductor hiatus - the terminal end of the AC. Our study will require placement of the continuous ACB no more distal than 20cm cephalad to the superior pole of the patella due to placement prior to surgery and the need to keep the dressing out of the operative field. The CACB catheter will also not be placed any more proximal than 20cm distal to the ASIS. In addition to other exclusion criteria, these measurements will create an exclusion for patients with an iliac-to-patella distance less than 40cm. Iliac to Patella distance (IPD) will be measured at the pre-operative interview on the day of surgery with a measuring tape. External palpable landmarks of the Anterior superior iliac spine and the superior pole of the patella will be used.
The primary outcome is based upon the ability to perform rehabilitation exercises postoperatively to the extent that criteria for discharge can be met. The primary outcome measured is the time at which a patient gains the ability to successfully perform a 75-feet unassisted walk. On the Day of Surgery (DOS), prior to any walking attempt, a secondary outcome measure will be to perform a 5-second sustained straight leg raise. Other secondary outcomes will be the number of days admitted prior to discharge, and average pain scores on DOS, Postoperative Day (POD) #1, and POD#2. The Day of discharge will also be used as a secondary outcome. Earlier discharge is becoming a goal of almost all healthcare systems to minimize costs.
Detailed description
The three arms are as follows:
- The control group; Continuous Femoral Nerve Block - Low Dose (CFNB-LD) will be patients randomized to our standard therapy comprised of a low dose/concentration Continuous Femoral Nerve Block inserted approximately 5cm distal to the groin crease with a rate of 2ml/hr.
- Higher dose (HD) CFNB; - block placed in same location as CFNB-LD but with a higher dose rate of 4ml/hr. This higher rate could afford more pain control but may cause more quadriceps or hip flexor weakness.
- Continuous Adductor Canal Block (CACB) group will have a catheter inserted 20-30cm proximal to the superior pole of the patella, and an infusion rate of 4ml/hr, but with similar dressing to make it appear like those in group 1 and 2.
Acute Pain/Regional anesthesiologists and fellows will be performing all research procedures in the same locations that the investigators routinely perform regional nerve blocks: our preoperative holding area adjacent to the operating room suites at University of Pittsburgh Medical Center (UPMC) - Passavant.
All three groups have a set rate that will not increase. There also will be no bolus orders given on the floors, however IV and PO medications will be available to decrease discomfort. These medications are ordered to be given upon request (PRN); upon patient request. Down-regulation of doses will also not be allowed as that would cause uncertainty as to which regimen may contribute most to postoperative weakness. The only adjustment allowed will be to turn off the nerve block infusion completely on POD #1 if a dense motor block of the quadriceps or iliopsoas (hip flexor) exists, as this condition does not facilitate participation in rehabilitation exercises. The frequency of early-removal of nerve block will be recorded for all three groups.
CFNB groups Continuous Femoral Nerve Block placement: The skin of the right or left groin will be sterilized and draped under sterile conditions, the femoral nerve will be identified using ultrasound just below the inguinal crease and the local anesthetic will be infiltrated subcutaneously. The needle is inserted at the lateral edge of the probe and directed toward the nerve using ultrasound assistance. When in proximity of the nerve, 15ml of 0.2% ropivacaine will be injected through the needle with repeat aspiration every 5 ml. The nerve block catheter will be placed 3-5 cm past the needle tip and secured with steri strips and bio-occlusive dressing.
CACB group Continuous Adductor Canal Block placement: The distance from the ASIS to the superior pole of the patella will be measured and the distance recorded. This Iliac-to-Patella distance (IPD) will be divided into proximal and distal halves, and the halfway point marked. The length of the IPD will need to be a minimum of 40cm for inclusion. The insertion site will need to be 20cm proximal to the superior pole of the patella and at least 20ml distal to the ASIS. The attending anesthesiologist / acute pain attending either perform or supervise regional anesthesia fellows to place the CACB no more proximal than the halfway mark of the IPD. For example, if a patient has an IPD of 50cm, the halfway mark will be at 25cm and this would be the site of insertion as it would be within the anatomic adductor canal and would be adequately removed from the surgical site. The skin of the right or left anterior-medial thigh will be sterilized and draped under sterile conditions. The sartorius muscle and femoral artery will be identified by an ultrasound at the marked IPD-halfway-mark. There, local anesthetic will be infiltrated subcutaneously. The needle is inserted in the direction of the hyperechoic nerve and the hypoechoic femoral artery using ultrasound assistance. When the needle tip is deep to the sartorius and in proximity of the artery, 15ml of 0.2% ropivacaine will be injected through the needle with repeat aspiration every 5 ml. The nerve catheter will be placed 3-5 cm past the needle tip and secured with steri-strips and bio-occlusive dressing. The CACB rate will be 4ml/hr of bupivacaine 0.0625%.
By design, Observers should only be aware of a singular kind of patient; those with CPNBs.
The dressing of the cACB will be very similar to the CFNB and the standard yellow connector piece will be secured to the skin with bio-occlusive covering, and the location will be at level of the anterior superior iliac spine (ASIS). This standardized dressing will serve to aid in blinding the observers as to which kind of continuous block the patient received. Labeling of the catheter and dressing will not differ. The nerve block billing record will contain the information on the particular approach used.
Sciatic nerve block placement: the corresponding right or left gluteal area will be sterilized and draped under sterile conditions, the sciatic nerve will be identified by an ultrasound in the lower gluteal region where a local anesthetic will be infiltrated subcutaneously. A trans-gluteal approach will be used to inject normal saline through the needle to assist catheter placement; the catheter will be introduced for 3-5 cm past the needle tip and secured with steri strips and tegaderm. No local anesthetic will be administered until the postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cont. Femoral Block - Low Dose Group | Active comparator | Procedure: Continuous Femoral Nerve Block, Procedure: Continuous Sciatic Nerve Block, Drug: BupivacaineArm is named by the intervention the group receives. Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2. |
| Cont. Femoral Block - Higher Dose | Experimental | Procedure: Continuous Femoral Nerve Block, Procedure: Continuous Sciatic Nerve Block, Drug: BupivacainePlace the CPNB in same manner as low-dose group, but rate will be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy |
| Continuous Adductor Canal | Experimental | Procedure: Nerve Block, Continuous Adductor Canal, Procedure: Continuous Sciatic Nerve Block, Drug: BupivacainePlaced at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Able to consent to regional anesthesia and having primary total knee arthroplasty/replacement
Key exclusion criteria (3 listed)
- Body-Mass Index >40
- Iliac to Patella Distance (IPD) <40cm
- Pre-existing quadriceps weakness of involved surgical side Chronic opioid use (if using opioids within 4 weeks of surgery: excluded)
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 |
|---|---|---|
| Continuous Femoral Nerve BlockAlso: Continuous Nerve Block, Femoral, Continuous Peripheral Nerve BlockA 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty | Procedure or surgery | Cont. Femoral Block - Higher Dose, Cont. Femoral Block - Low Dose Group |
| Nerve Block, Continuous Adductor CanalAlso: Continuous Nerve Block, Adductor Canal, Continuous Peripheral Nerve Block, Adductor CanalA 27g plastic catheter placed on the anterior medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty | Procedure or surgery | Continuous Adductor Canal |
| Continuous Sciatic Nerve BlockAlso: Nerve Block, Sciatic ContinuousA transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty. | Procedure or surgery | Cont. Femoral Block - Higher Dose, Cont. Femoral Block - Low Dose Group, Continuous Adductor Canal |
| BupivacaineThe concentration of the continuous infusion of bupivacaine though the peripheral nerve catheters will be 0.0625% for the femoral and adductor canal blocks and the concentration for the sciatic continuous catheter will be 0.03%. | Drug | Cont. Femoral Block - Higher Dose, Cont. Femoral Block - Low Dose Group, Continuous Adductor Canal |
Primary outcome
Time to Achieve Physical Therapy Discharge Criteria as Measured by 75-feet Walk Test. {Number of Hours After Conclusion of Surgery}
Time frame: Participants will be followed for the duration of hospital stay, an average of 4 days
Ability to walk 75 feet if performed on POD#2 is usually considered the main criterion for discharge at UPMC Passavant. The patient is accompanied/supervised by physical therapist using a walker but without active intervention by therapist, unless necessary. The earliest day on which the patient achieves the 75-feet unassisted walk will be recorded for comparison among the arms/groups.
3 secondary outcomes
Average Length of Stay (to be Reported in Hours After Surgery)
Time frame: Participants will be followed for the duration of hospital stay; No patients will be discharged on the day of surgery; The earliest discharge would be at 24 hours. Those hospitalized beyond 96 hours will be excluded.
Postoperative Pain, Average Reported Score 11-point Scale
Time frame: postoperative day one
Sustained Straight Leg Raise
Time frame: Day of Surgery (DOS) - In Postoperative Recovery Unit, prior to any walking atempt
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- 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.
Waters Jonathan, MD study chair
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous Femoral Nerve Block, Nerve Block, Continuous Adductor Canal and Continuous Sciatic Nerve Block in people with Pain, Postoperative and Total Knee Arthroplasty (TKA), run by Kevin King, DO 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 1 inclusion and 3 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 27 Mar 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2018). 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?
Time to Achieve Physical Therapy Discharge Criteria as Measured by 75-feet Walk Test. {Number of Hours After Conclusion of Surgery} (time frame: Participants will be followed for the duration of hospital stay, an average of 4 days). 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 27 Mar 2018.