Posterior Knee Infiltration
Conditions
Keywords
Infiltration between popliteal artery and capsule of knee (iPACK)
Brief 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.
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.
Interventions
DRUGRopivacaine with Epinephrine
Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
DRUGRopivacaine
Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
Sponsors
Trinity Health Of New England
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients having primary, unilateral total knee arthroplasty * Age 18-80
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 24 hours post surgery | Amount of opioid used for the first 24 hours post surgery |
| Plantar Flexion in the Tibial Nerve Distribution | Upon emergence from anesthesia in the PACU | Blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block) |
| Cold Sensation in the Tibial Nerve Distribution | Upon emergence from anesthesia in the PACU | 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) |
| Dorsiflexion in the Peroneal Nerve Distribution | Upon emergence from anesthesia in the PACU | 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) |
| Sensation in the Peroneal Nerve Distribution | Upon emergence from anesthesia in the PACU | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Posterior Capsular Injection Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles | 42 |
| Tibial Nerve Block Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa | 36 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete Data | 0 | 2 |
Baseline characteristics
| Characteristic | Posterior Capsular Injection | Tibial Nerve Block | Total |
|---|---|---|---|
| Age, Continuous | 65.9 Years STANDARD_DEVIATION 8 | 63.5 Years STANDARD_DEVIATION 8.9 | 64.8 Years STANDARD_DEVIATION 8.43 |
| Region of Enrollment United States | 42 participants | 36 participants | 78 participants |
| Sex: Female, Male Female | 24 Participants | 19 Participants | 43 Participants |
| Sex: Female, Male Male | 18 Participants | 17 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 36 |
| other Total, other adverse events | 0 / 42 | 0 / 36 |
| serious Total, serious adverse events | 0 / 42 | 0 / 36 |
Outcome results
Primary
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
Time frame: 48 hours post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Posterior Capsular Injection | Pain Intensity | 24th hour | 2.7 pain score | Standard Deviation 2.21 |
| Posterior Capsular Injection | Pain Intensity | 30th hour | 2.6 pain score | Standard Deviation 2.4 |
| Posterior Capsular Injection | Pain Intensity | 36th hour | 2.5 pain score | Standard Deviation 2.46 |
| Posterior Capsular Injection | Pain Intensity | 42nd hour | 3.2 pain score | Standard Deviation 1.82 |
| Posterior Capsular Injection | Pain Intensity | 48th hour | 2.5 pain score | Standard Deviation 1.98 |
| Posterior Capsular Injection | Pain Intensity | PACU Admission | 3.5 pain score | Standard Deviation 2.95 |
| Posterior Capsular Injection | Pain Intensity | PACU Discharge | 2.1 pain score | Standard Deviation 1.78 |
| Posterior Capsular Injection | Pain Intensity | 6th hour | 1.9 pain score | Standard Deviation 1.85 |
| Posterior Capsular Injection | Pain Intensity | 12th hour | 2.0 pain score | Standard Deviation 2.36 |
| Posterior Capsular Injection | Pain Intensity | 18th hour | 2.3 pain score | Standard Deviation 2.21 |
| Tibial Nerve Block | Pain Intensity | 6th hour | 2.0 pain score | Standard Deviation 2.17 |
| Tibial Nerve Block | Pain Intensity | 24th hour | 3.4 pain score | Standard Deviation 2.42 |
| Tibial Nerve Block | Pain Intensity | PACU Admission | 3.2 pain score | Standard Deviation 3.67 |
| Tibial Nerve Block | Pain Intensity | 30th hour | 3.0 pain score | Standard Deviation 2.43 |
| Tibial Nerve Block | Pain Intensity | 18th hour | 3.2 pain score | Standard Deviation 2.36 |
| Tibial Nerve Block | Pain Intensity | 36th hour | 2.7 pain score | Standard Deviation 2.53 |
| Tibial Nerve Block | Pain Intensity | PACU Discharge | 1.5 pain score | Standard Deviation 1.73 |
| Tibial Nerve Block | Pain Intensity | 42nd hour | 3.2 pain score | Standard Deviation 2.5 |
| Tibial Nerve Block | Pain Intensity | 12th hour | 1.2 pain score | Standard Deviation 2.03 |
| Tibial Nerve Block | Pain Intensity | 48th hour | 3.4 pain score | Standard Deviation 2.4 |
Secondary
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)
Time frame: Upon emergence from anesthesia in the PACU
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Posterior Capsular Injection | Cold Sensation in the Tibial Nerve Distribution | Complete Sensory Block | 1 Participants |
| Posterior Capsular Injection | Cold Sensation in the Tibial Nerve Distribution | Partial Sensory Block | 7 Participants |
| Posterior Capsular Injection | Cold Sensation in the Tibial Nerve Distribution | No Sensory Block | 34 Participants |
| Tibial Nerve Block | Cold Sensation in the Tibial Nerve Distribution | Complete Sensory Block | 6 Participants |
| Tibial Nerve Block | Cold Sensation in the Tibial Nerve Distribution | Partial Sensory Block | 27 Participants |
| Tibial Nerve Block | Cold Sensation in the Tibial Nerve Distribution | No Sensory Block | 3 Participants |
Secondary
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)
Time frame: Upon emergence from anesthesia in the PACU
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Posterior Capsular Injection | Dorsiflexion in the Peroneal Nerve Distribution | Complete Motor Block | 0 Participants |
| Posterior Capsular Injection | Dorsiflexion in the Peroneal Nerve Distribution | Partial Motor Block | 1 Participants |
| Posterior Capsular Injection | Dorsiflexion in the Peroneal Nerve Distribution | No Motor Block | 41 Participants |
| Tibial Nerve Block | Dorsiflexion in the Peroneal Nerve Distribution | Complete Motor Block | 0 Participants |
| Tibial Nerve Block | Dorsiflexion in the Peroneal Nerve Distribution | Partial Motor Block | 4 Participants |
| Tibial Nerve Block | Dorsiflexion in the Peroneal Nerve Distribution | No Motor Block | 32 Participants |
Secondary
Opioid Consumption
Amount of opioid used for the first 24 hours post surgery
Time frame: 24 hours post surgery
Population: Mean consumption of Hydromorphone(mg) post-op day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterior Capsular Injection | Opioid Consumption | 0.33 mg | Standard Deviation 0.655 |
| Tibial Nerve Block | Opioid Consumption | 0.42 mg | Standard Deviation 0.706 |
Secondary
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)
Time frame: Upon emergence from anesthesia in the PACU
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Posterior Capsular Injection | Plantar Flexion in the Tibial Nerve Distribution | Complete Motor Block | 1 Participants |
| Posterior Capsular Injection | Plantar Flexion in the Tibial Nerve Distribution | Partial Motor Block | 3 Participants |
| Posterior Capsular Injection | Plantar Flexion in the Tibial Nerve Distribution | No Motor Block | 38 Participants |
| Tibial Nerve Block | Plantar Flexion in the Tibial Nerve Distribution | Complete Motor Block | 0 Participants |
| Tibial Nerve Block | Plantar Flexion in the Tibial Nerve Distribution | Partial Motor Block | 25 Participants |
| Tibial Nerve Block | Plantar Flexion in the Tibial Nerve Distribution | No Motor Block | 11 Participants |
Secondary
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)
Time frame: Upon emergence from anesthesia in the PACU
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Posterior Capsular Injection | Sensation in the Peroneal Nerve Distribution | Complete Sensory Block | 2 Participants |
| Posterior Capsular Injection | Sensation in the Peroneal Nerve Distribution | Partial Sensory Block | 3 Participants |
| Posterior Capsular Injection | Sensation in the Peroneal Nerve Distribution | No Sensory Block | 37 Participants |
| Tibial Nerve Block | Sensation in the Peroneal Nerve Distribution | Complete Sensory Block | 1 Participants |
| Tibial Nerve Block | Sensation in the Peroneal Nerve Distribution | Partial Sensory Block | 11 Participants |
| Tibial Nerve Block | Sensation in the Peroneal Nerve Distribution | No Sensory Block | 24 Participants |