Arthroplasty, Replacement, KneePhase 4NCT04290442
Adductor Canal Vs Adductor Canal Plus SPANK Block for Postoperative Pain in Knee Arthroplasty Surgery
A Phase 4 study testing adductor canal block, SPANK and Ropivacaine in people with Arthroplasty, Replacement, Knee and Anesthesia, Conduction, run by Bruce Ben-David at 1 site in United States.
Trial summary
This study will prospectively investigate the efficacy of Adductor canal block with periarticular infiltration Vs Adductor canal block, Periarticluar infiltration and Sensory posterior articular nerve of the knee block in patients undergoing total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Anesthesia, Conduction, Acute Pain
- What is being tested?
- adductor canal block, SPANK and Ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Jun 2021
- Phase
- Phase 4
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 19 and 90 years old. BMI 18-45 ASA class I-II-III
Who cannot join
- Simultaneous bilateral TKA.
- History of substance abuse.
- BMI >45.
- Patients that did not received Intrathecal anesthesia.
- Infection at the site of injection (either for spinal or PNB).
- Pregnancy.
Show all 12Show fewer
- Non english speaking or inability to participate in the study.
- Patients with coagulopathy or With INR >1,5 the day of the surgery.
- Pharmacologic coagulopathy: patients on xarelto, plavix, or any kind of "Blood Thinners".
- Chronic steroid use: patients with consumption of steroid for more than 3 months.
- Chronic pain: pain for more than 3 months.
- Chronic opiate use : consumption of opioids for more than 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Prospective Randomized Parallel Study to Compare Post-operative Pain Control With Addition of Sensory Posterior Articular Nerve Block to Adductor Canal Block (SPANK) and Intraoperative Periarticular Infiltration in Total Knee Arthroplasty.
This study will prospectively investigate the efficacy of Adductor canal block with periarticular infiltration Vs Adductor canal block, Periarticluar infiltration and Sensory posterior articular nerve of the knee block in patients undergoing total knee arthroplasty. The study will aid in answering question whether SPANK block is an effective adjunct in preventing posterior knee pain without causing motor blockade.
Read the detailed description
Total knee arthroplasty (TKA)is a common orthopedic surgical procedure. Optimal pain control is necessary for early recovery and discharge. TKA is considered one of the more painful surgical procedures, peripheral nerve blocks and multimodal analgesia are incorporated into clinical practice to provide patient comfort, decrease postoperative opioid requirement, facilitate early ambulation and enhance patient satisfaction.Adductor canal nerve block (ACB) and intraoperative periarticular infiltration (PAI) are routine clinical practice followed at our institute for postoperative pain control. Although ACB provided analgesia to peripatellar and anterior intra-articular aspect of knee joint, it does not relieve posterior knee pain which can be moderate to severe in intensity. Many techniques have been employed for posterior knee pain including sciatic nerve block and infiltration between popliteal artery and posterior capsule of the knee joint (IPACK) with limited success. Sciatic nerve block is considered gold standard but is rarely used due to associated motor weakness, which may delay ambulation and decrease participation in physical therapy postoperatively . In recent times IPACK block has gained popularity but there are concerns about local anesthetic injection close to surgical field and total dose of local anesthetic exceeding the recommended amount if combined with periarticular infiltration as is the practice at our institute.
SPANK block was described in 2015 by Kardash et al for posterior knee pain while sparing motor function. The block is performed at the level of femoral shaft above the femoral epicondyle, on the medial side of the leg, with needle positioned just superficial to posteromedial femoral periosteum and 15 ml of local anesthetic is injected, decreasing concerns for local anesthetic toxicity, and invasiveness close to surgical field as compared to IPACK block which requires 30 ml of local anesthetic.
Efficacy of SPANK block has been demonstrated as rescue analgesic for posterior knee pain after TKA, and a trial is underway to evaluate efficacy of ACB an SPANK block versus ACB alone [5].There is no literature evaluating benefit of SPANK block when added to ACB and PAI which is a standard practice.
If SPANK block proves to be effective in controlling posterior knee pain, with motor sparing effect it can help reduce postoperative opioid requirement, help achieve same day discharge and prove to be another small step towards fighting opioid epidemic.
Hence, we propose this study to evaluate added benefit of SPANK block to ACB and PAI with regards to postoperative pain control.
- Being tested
- adductor canal block, SPANK, Ropivacaine
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adductor canal blockProcedure or surgery
The block is performed in supine position under ultrasound guidance using 22 G Touhy needle advanced in plane and 15 cc of 0.5% Ropivacaine ( local anesthetic) with dexmedetomidine 20-30 mcg depending on the age of the patient is injected at midthigh level lateral to the femoral artery in adductor canal to provide sensory blockade to the anterior aspect of the knee.
SPANKProcedure or surgery
SPANK: The block is performed in supine position, using 22 G Touhy needle, under ultrasound guidance, needle is advanced in plane to posteromedial shaft of femur taking care to avoid popliteal artery, and 0.5% ropivacaine 15 cc, dexmedetomidine 20-30mcg and dexamethasone 4 mg is injected into inner thigh above the knee provide sensory block to posterior aspect of the knee.
RopivacaineDrug
ropivacaine 0.5% will be use in the block
| Study group | Role | What they receive |
|---|---|---|
| Adductor canal block (ACB) | Active comparator | Not described Receives: Procedure: adductor canal block; Drug: Ropivacaine |
| Adductor canal block plus SPANK block | Experimental | Not described Receives: Procedure: adductor canal block; Procedure: SPANK; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score using Numerical rating Scale (NRS) with ambulation at 24 hours after total knee arthroplasty
Patient will describe the pain experienced after surgery on a scale from 1-10 being 10 the worst pain ever experienced, this will be registered in the format designed for this purpose and at the end of the study will be analyzed
Measured: At 24 hours after surgery
Secondary outcomes (8)
Pain scores at rest and with movement at 6, 12 and 24 hours after the surgery measured using Numerical Rating Scale (NRS).
Patient will describe the pain experienced after surgery in rest and in movement at 6,12,24 hours on a scale from 1-10 being 10 the worst pain ever experienced.
Measured: It will be measured at 6 hours, 12 hours, 24 hours after surgery
Time to first opioid Consumption
The amount of time measured from the end of the surgery when the patient leaves the operating room to the time when they receive their first dose of any opioid medication.
Measured: During the first 24 after surgery
Opioid consumption
will be measured using morphine equivalents during first 24 hours after knee surgery, starting when the patient leaves the operating room
Measured: During the first 24 after surgery
Extent of motor blockade in various lower extremity muscle groups
This outcome will be reported by physical therapy on medical records
Measured: During the first 24 after surgery
Time that the patient takes to walk 100 feet after surgery
This outcome will be reported by physical therapy on medical records
Measured: During the first 24 after surgery
Patient satisfaction with the pain management strategy provided after first 24 hours.
patient satisfaction survey will be answered by the patient at 24 hours after surgery. This questionnaire will have a score of satisfaction from1-5, being 5 the maximum satisfaction experienced by the patient.
Measured: During the first 24 after surgery
Local anesthetic toxicity reported in the medical records if is present.
Local Anesthetic Toxicity is defined by symptoms such as metallic taste, tinnitus, drowsiness, after administering a dose of local anesthetics.This will be reported in the medical record and by the physician on call.t We will measure the number of participants that present these kind of symptoms if any.
Measured: During the first 24 after surgery
Nausea and vomiting
The presence or absence of nausea and vomiting, and the number of episodes during the first 24 hours after surgery.The outcome assessor will ask directly to the patient about this symptoms.we will measure the number of patients that report these symptoms.
Measured: During the first 24 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Jan 2021 (estimated)
- Primary completion15 Mar 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Why it stopped: initially cessation due to covid, then fellow doing the study graduated with no time to complete the study; will take up again if a current fellow takes on the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies 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
- Model description
- The study will be conducted as prospective, randomized, single blinded, parallel trial at the University of Pittsburgh Medical Center (UPMC) Shadyside Hospital.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruce Ben-David
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bruce Ben-David, University of Pittsburgh
- Investigators
- Bruce Ben-David, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290442
- Sponsor's protocol ID
- STUDY19120105
- Status last verified
- Nov 2020
- First submitted
- 26 Feb 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Publications
Karlsen AP, Wetterslev M, Hansen SE, Hansen MS, Mathiesen O, Dahl JB. Postoperative pain treatment after total knee arthroplasty: A systematic review. PLoS One. 2017 Mar 8;12(3):e0173107. doi: 10.1371/journal.pone.0173107. eCollection 2017.
PubMed 28273133Vora MU, Nicholas TA, Kassel CA, Grant SA. Adductor canal block for knee surgical procedures: review article. J Clin Anesth. 2016 Dec;35:295-303. doi: 10.1016/j.jclinane.2016.08.021. Epub 2016 Oct 11.
PubMed 27871547Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.
PubMed 29721648
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Parallel Study to Compare Post-operative Pain Control With Addition of Sensory Posterior Articular Nerve Block to Adductor Canal Block (SPANK) and Intraoperative Periarticular Infiltration in Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT04290442
- Acronym / sponsor ID
- STUDY19120105
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: initially cessation due to covid, then fellow doing the study graduated with no time to complete the study; will take up again if a current fellow takes on the project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bruce Ben-DavidUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 15 Mar 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 2 Mar 2020 (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.
This study will prospectively investigate the efficacy of Adductor canal block with periarticular infiltration Vs Adductor canal block, Periarticluar infiltration and Sensory posterior articular nerve of the knee block in patients undergoing total knee arthroplasty. The study will aid in answering question whether SPANK block is an effective adjunct in preventing posterior knee pain without causing motor blockade.
Detailed description
Total knee arthroplasty (TKA)is a common orthopedic surgical procedure. Optimal pain control is necessary for early recovery and discharge. TKA is considered one of the more painful surgical procedures, peripheral nerve blocks and multimodal analgesia are incorporated into clinical practice to provide patient comfort, decrease postoperative opioid requirement, facilitate early ambulation and enhance patient satisfaction.Adductor canal nerve block (ACB) and intraoperative periarticular infiltration (PAI) are routine clinical practice followed at our institute for postoperative pain control. Although ACB provided analgesia to peripatellar and anterior intra-articular aspect of knee joint, it does not relieve posterior knee pain which can be moderate to severe in intensity. Many techniques have been employed for posterior knee pain including sciatic nerve block and infiltration between popliteal artery and posterior capsule of the knee joint (IPACK) with limited success. Sciatic nerve block is considered gold standard but is rarely used due to associated motor weakness, which may delay ambulation and decrease participation in physical therapy postoperatively . In recent times IPACK block has gained popularity but there are concerns about local anesthetic injection close to surgical field and total dose of local anesthetic exceeding the recommended amount if combined with periarticular infiltration as is the practice at our institute.
SPANK block was described in 2015 by Kardash et al for posterior knee pain while sparing motor function. The block is performed at the level of femoral shaft above the femoral epicondyle, on the medial side of the leg, with needle positioned just superficial to posteromedial femoral periosteum and 15 ml of local anesthetic is injected, decreasing concerns for local anesthetic toxicity, and invasiveness close to surgical field as compared to IPACK block which requires 30 ml of local anesthetic.
Efficacy of SPANK block has been demonstrated as rescue analgesic for posterior knee pain after TKA, and a trial is underway to evaluate efficacy of ACB an SPANK block versus ACB alone [5].There is no literature evaluating benefit of SPANK block when added to ACB and PAI which is a standard practice.
If SPANK block proves to be effective in controlling posterior knee pain, with motor sparing effect it can help reduce postoperative opioid requirement, help achieve same day discharge and prove to be another small step towards fighting opioid epidemic.
Hence, we propose this study to evaluate added benefit of SPANK block to ACB and PAI with regards to postoperative pain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be conducted as prospective, randomized, single blinded, parallel trial at the University of Pittsburgh Medical Center (UPMC) Shadyside Hospital.
| Arm | Type | Receives |
|---|---|---|
| Adductor canal block (ACB) | Active comparator | Procedure: adductor canal block, Drug: Ropivacaine |
| Adductor canal block plus SPANK block | Experimental | Procedure: adductor canal block, Procedure: SPANK, Drug: Ropivacaine |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the ages of 19 and 90 years old. BMI 18-45 ASA class I-II-III
Key exclusion criteria (12 listed)
- Simultaneous bilateral TKA.
- History of substance abuse.
- BMI >45.
- Patients that did not received Intrathecal anesthesia.
- Infection at the site of injection (either for spinal or PNB).
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 |
|---|---|---|
| adductor canal blockThe block is performed in supine position under ultrasound guidance using 22 G Touhy needle advanced in plane and 15 cc of 0.5% Ropivacaine ( local anesthetic) with dexmedetomidine 20-30 mcg depending on the age of the patient is injected at midthigh level lateral to the femoral artery in adductor canal to provide sensory blockade to the anterior aspect of the knee. | Procedure or surgery | Adductor canal block (ACB), Adductor canal block plus SPANK block |
| SPANKSPANK: The block is performed in supine position, using 22 G Touhy needle, under ultrasound guidance, needle is advanced in plane to posteromedial shaft of femur taking care to avoid popliteal artery, and 0.5% ropivacaine 15 cc, dexmedetomidine 20-30mcg and dexamethasone 4 mg is injected into inner thigh above the knee provide sensory block to posterior aspect of the knee. | Procedure or surgery | Adductor canal block plus SPANK block |
| Ropivacaineropivacaine 0.5% will be use in the block | Drug | Adductor canal block (ACB), Adductor canal block plus SPANK block |
Primary outcome
Pain score using Numerical rating Scale (NRS) with ambulation at 24 hours after total knee arthroplasty
Time frame: At 24 hours after surgery
Patient will describe the pain experienced after surgery on a scale from 1-10 being 10 the worst pain ever experienced, this will be registered in the format designed for this purpose and at the end of the study will be analyzed
8 secondary outcomes
Pain scores at rest and with movement at 6, 12 and 24 hours after the surgery measured using Numerical Rating Scale (NRS).
Time frame: It will be measured at 6 hours, 12 hours, 24 hours after surgery
Time to first opioid Consumption
Time frame: During the first 24 after surgery
Opioid consumption
Time frame: During the first 24 after surgery
Extent of motor blockade in various lower extremity muscle groups
Time frame: During the first 24 after surgery
Time that the patient takes to walk 100 feet after surgery
Time frame: During the first 24 after surgery
Patient satisfaction with the pain management strategy provided after first 24 hours.
Time frame: During the first 24 after surgery
Local anesthetic toxicity reported in the medical records if is present.
Time frame: During the first 24 after surgery
Nausea and vomiting
Time frame: During the first 24 after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Background: PubMed 28273133Karlsen AP, Wetterslev M, Hansen SE, Hansen MS, Mathiesen O, Dahl JB. Postoperative pain treatment after total knee arthroplasty: A systematic review. PLoS One. 2017 Mar 8;12(3):e0173107. doi: 10.1371/journal.pone.0173107. eCollection 2017.
- Background: PubMed 27871547Vora MU, Nicholas TA, Kassel CA, Grant SA. Adductor canal block for knee surgical procedures: review article. J Clin Anesth. 2016 Dec;35:295-303. doi: 10.1016/j.jclinane.2016.08.021. Epub 2016 Oct 11.
- Background: PubMed 29721648Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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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.
Bruce Ben-David, MD principal investigator
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 adductor canal block, SPANK and Ropivacaine in people with Arthroplasty, Replacement, Knee and Anesthesia, Conduction, run by Bruce Ben-David 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 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: withdrawn, as of the sponsor's last update on 24 Nov 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 score using Numerical rating Scale (NRS) with ambulation at 24 hours after total knee arthroplasty (time frame: At 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04290442, which also lists 3 linked publications.
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 24 Nov 2020.