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To assess pain control after total knee replacement surgery using two different nerve block techniques. The 2 methods are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posterior capsular injection | Experimental | Ultrasound guided posterior capsular injection of ropivacaine with epinephrine |
|
| Tibial nerve block | Active Comparator | Ultrasound selective tibial nerve block of ropivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine with Epinephrine | Drug | Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 hours post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Amount of opioid used for the first 24 hours post surgery | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Sinha | Saint Francis Hospital and Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Tibial Nerve Block | Ultrasound selective tibial nerve block of ropivacaine Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | pain score | 48 hours post surgery |
|
24 hours after total knee replacement surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjay Sinha, MD | ST. FRANCIS HOSPITAL AND MEDICAL CENTER | sanjaysinha@comcast.net |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Ropivacaine | Drug | Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa |
|
|
| 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) | 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) | 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) | Upon emergence from anesthesia in the PACU |
| Tibial Nerve Block |
Ultrasound selective tibial nerve block of ropivacaine Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Opioid Consumption | Amount of opioid used for the first 24 hours post surgery | Mean consumption of Hydromorphone(mg) post-op day 1 | Posted | Mean | Standard Deviation | mg | 24 hours post surgery |
|
|
|
| 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) | Posted | Count of Participants | Participants | No | Upon emergence from anesthesia in the PACU |
|
|
|
| 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) | Posted | Count of Participants | Participants | Upon emergence from anesthesia in the PACU |
|
|
|
| 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) | Posted | Count of Participants | Participants | Upon emergence from anesthesia in the PACU |
|
|
|
| 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) | Posted | Count of Participants | Participants | Upon emergence from anesthesia in the PACU |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Tibial Nerve Block | Ultrasound selective tibial nerve block of ropivacaine Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa | 0 | 36 | 0 | 36 | 0 | 36 |
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| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| No Motor Block |
|
| No Sensory Block |
|
| No Motor Block |
|
| No Sensory Block |
|