Posterior Knee InfiltrationNCT02701296
Posterior Capsular Injection With Femoral Nerve Block for Total Knee Arthroplasty
A study testing Ropivacaine with Epinephrine and Ropivacaine in people with Posterior Knee Infiltration, run by Trinity Health Of New England at 1 site in United States.
Trial summary
To assess pain control after total knee replacement surgery using two different nerve block techniques. The 2 methods are: 1. Continuous femoral nerve block with ultrasound guided posterior capsular injection 2. Continuous femoral nerve block with ultrasound selective tibial nerve block. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Posterior Knee Infiltration
- What is being tested?
- Ropivacaine with Epinephrine and Ropivacaine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2011to 31 Aug 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having primary, unilateral total knee arthroplasty
- Age 18-80
Who cannot join
- History of neurologic disease, neuropathy, diabetes, or major systemic illness
- Allergy to local anesthetic solution or NSAIDs
- Pregnancy
- Chronic use of narcotics
- Inability to give consent/cooperate with study
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105
About this study
Official title: Assessment of Knee Pain in Patients Receiving Continuous Femoral Nerve Block Combined With Either Ultrasound Guided Posterior Capsular Injection or Selective Tibial Nerve Block Following Total Knee Arthroplasty
To assess pain control after total knee replacement surgery using two different nerve block techniques. The 2 methods are:
- Continuous femoral nerve block with ultrasound guided posterior capsular injection
- Continuous femoral nerve block with ultrasound selective tibial nerve block.
Read the detailed description
Patients undergoing total knee replacement surgery experience severe post-operative pain. Continuous femoral nerve block combined with selective tibial nerve block provides optimal pain control in the anterior and posterior aspect of the knee respectively. However, in patients with pre-existing neuropathy of the sciatic nerve, the blockade of tibial nerve is contraindicated because of increased risk of nerve damage that may lead to exacerbation of neurologic symptoms. In such patients where selective tibial nerve block cannot be offered, ultrasound guided posterior knee capsular injection may be an alternative technique for controlling posterior knee pain after surgery. Posterior capsular injection by surgeons intraoperatively, when combined with femoral nerve block has been shown to provide pain control after total knee replacement. With posterior capsular injection, the main trunk of the tibial nerve is spared and only the terminal nerve endings innervating the posterior knee joint is blocked providing effective pain control. In this study, the efficacy of ultrasound guided posterior capsular injections performed pre-operatively will be compared to tibial nerve block in controlling knee pain after surgery.
The results of this study may help establish the efficacy of ultrasound guided posterior capsular injection as an alternative to tibial nerve block in patients undergoing total knee arthroplasty.
- Conditions
- Posterior Knee Infiltration
- Being tested
- Ropivacaine with Epinephrine, Ropivacaine
- Keywords
- Infiltration between popliteal artery and capsule of knee (iPACK)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine with EpinephrineDrug
Also called Naropin, Adrenalin
Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
RopivacaineDrug
Also called Naropin
Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
| Study group | Role | What they receive |
|---|---|---|
| Posterior capsular injection | Experimental | Ultrasound guided posterior capsular injection of ropivacaine with epinephrine Receives: Drug: Ropivacaine with Epinephrine |
| Tibial nerve block | Active comparator | Ultrasound selective tibial nerve block of ropivacaine Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Mean Numeric Pain Rating Scale (NPRS) self-reported pain Intensity on a 11-point score (0=no pain to 10= worst possible) in Post Anesthesia Care Unit (PACU) and every 6 hours for 48 hours post surgery
Measured: 48 hours post surgery
Secondary outcomes (5)
Opioid Consumption
Amount of opioid used for the first 24 hours post surgery
Measured: 24 hours post surgery
Plantar Flexion in the Tibial Nerve Distribution
Blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block)
Measured: Upon emergence from anesthesia in the PACU
Cold Sensation in the Tibial Nerve Distribution
Number of participants with a self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block)
Measured: Upon emergence from anesthesia in the PACU
Dorsiflexion in the Peroneal Nerve Distribution
Number of participants with a blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block)
Measured: Upon emergence from anesthesia in the PACU
Sensation in the Peroneal Nerve Distribution
Number of participants with self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block)
Measured: Upon emergence from anesthesia in the PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start7 Nov 2011
- Primary completion31 Aug 2014
- Study completion31 Aug 2014
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 Posterior Knee InfiltrationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Sinha, Principal investigator, Saint Francis Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701296
- Sponsor's protocol ID
- 11-10-004
- Status last verified
- Oct 2018
- First submitted
- 17 Feb 2016
- Last updated
- 3 Oct 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 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Knee Pain in Patients Receiving Continuous Femoral Nerve Block Combined With Either Ultrasound Guided Posterior Capsular Injection or Selective Tibial Nerve Block Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02701296
- Acronym / sponsor ID
- 11-10-004
- Conditions
- Posterior Knee Infiltration
- Keywords
- Infiltration between popliteal artery and capsule of knee (iPACK)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Study start
- 7 Nov 2011 (actual)
- Primary completion
- 31 Aug 2014 (actual)
- Study completion
- 31 Aug 2014 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess pain control after total knee replacement surgery using two different nerve block techniques. The 2 methods are:
- Continuous femoral nerve block with ultrasound guided posterior capsular injection
- Continuous femoral nerve block with ultrasound selective tibial nerve block.
Detailed description
Patients undergoing total knee replacement surgery experience severe post-operative pain. Continuous femoral nerve block combined with selective tibial nerve block provides optimal pain control in the anterior and posterior aspect of the knee respectively. However, in patients with pre-existing neuropathy of the sciatic nerve, the blockade of tibial nerve is contraindicated because of increased risk of nerve damage that may lead to exacerbation of neurologic symptoms. In such patients where selective tibial nerve block cannot be offered, ultrasound guided posterior knee capsular injection may be an alternative technique for controlling posterior knee pain after surgery. Posterior capsular injection by surgeons intraoperatively, when combined with femoral nerve block has been shown to provide pain control after total knee replacement. With posterior capsular injection, the main trunk of the tibial nerve is spared and only the terminal nerve endings innervating the posterior knee joint is blocked providing effective pain control. In this study, the efficacy of ultrasound guided posterior capsular injections performed pre-operatively will be compared to tibial nerve block in controlling knee pain after surgery.
The results of this study may help establish the efficacy of ultrasound guided posterior capsular injection as an alternative to tibial nerve block in patients undergoing total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior capsular injection | Experimental | Drug: Ropivacaine with EpinephrineUltrasound guided posterior capsular injection of ropivacaine with epinephrine |
| Tibial nerve block | Active comparator | Drug: RopivacaineUltrasound selective tibial nerve block of ropivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients having primary, unilateral total knee arthroplasty
- Age 18-80
Key exclusion criteria (5 listed)
- History of neurologic disease, neuropathy, diabetes, or major systemic illness
- Allergy to local anesthetic solution or NSAIDs
- Pregnancy
- Chronic use of narcotics
- Inability to give consent/cooperate with study
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 |
|---|---|---|
| Ropivacaine with EpinephrineAlso: Naropin, AdrenalinPosterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles | Drug | Posterior capsular injection |
| RopivacaineAlso: NaropinTibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa | Drug | Tibial nerve block |
Primary outcome
Pain Intensity
Time frame: 48 hours post surgery
Mean Numeric Pain Rating Scale (NPRS) self-reported pain Intensity on a 11-point score (0=no pain to 10= worst possible) in Post Anesthesia Care Unit (PACU) and every 6 hours for 48 hours post surgery
5 secondary outcomes
Opioid Consumption
Time frame: 24 hours post surgery
Plantar Flexion in the Tibial Nerve Distribution
Time frame: Upon emergence from anesthesia in the PACU
Cold Sensation in the Tibial Nerve Distribution
Time frame: Upon emergence from anesthesia in the PACU
Dorsiflexion in the Peroneal Nerve Distribution
Time frame: Upon emergence from anesthesia in the PACU
Sensation in the Peroneal Nerve Distribution
Time frame: Upon emergence from anesthesia in the PACU
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Posterior Knee Infiltration
Recruiting
Comparison of Distal IPACK and Popliteal Plexus Block Combined With Femoral Triangle Block After Total Knee Arthroplasty
Osteo Arthritis of the Knee
Recruiting
Evaluation of the Effectiveness of iPACK and Adductor Canal Blocks on Patients Undergoing Arthroscopic Knee Surgery
Patients Undergoing Arthroscopic Knee Surgery
Recruiting
Genicular Nerve Block Versus Its Combination With Infiltration Between Popliteal Artery and Capsule of Posterior Knee
Postoperative Pain
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.
Sanjay Sinha principal investigator
Saint Francis Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine with Epinephrine and Ropivacaine in people with Posterior Knee Infiltration, run by Trinity Health Of New England at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 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 3 Oct 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). 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?
Pain Intensity (time frame: 48 hours post surgery). 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 3 Oct 2018.