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| Name | Class |
|---|---|
| Universidade do Porto | OTHER |
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The purpose of this study is to determine if the addition of a sciatic nerve block (SNB) to a continuous femoral nerve block (CFNB) improves post-operative analgesia after knee arthroplasty.
Background: Postoperative pain after total knee replacement /arthroplasty (TKA) is a major concern. It is severe pain in 60% of patients and moderate in 30%. Continuous femoral nerve blocks (CFNB) are considered an excellent choice for regional anesthesia for major knee repair but there are some controversies about the need of supplemental obturator or sciatic nerve blocks for achieving better postoperative analgesia. A recent meta-analysis states there is no sufficient evidence to recommend or discharge these associations.
Objectives: We aim to assess the efficacy of the association of a sciatic nerve block (SNB) and a continuous femoral nerve block (CFNB) for reducing postoperative pain in patients submitted to TKA. Methods: A randomized controlled study on 50 patients submitted to TKA. Control group receives a femoral nerve block with a catheter before general anesthesia is induced and the intervention group gets a similar block plus a single shot SNB before general anesthesia. Both groups start a continuous local anesthetic infusion through femoral catheter after the end of surgery and supplemental oral diclofenac and paracetamol. Pain scores are measured until 24h postoperatively, side effects and patient satisfaction are monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous femoral nerve block (CFNB) | Active Comparator | A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before induction of general anesthesia and surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in post anesthesia care unit (PACU) and maintained for 48h |
|
| Single shot SNB plus CFNB | Experimental | A single shot sciatic nerve block (SNB) is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block (CFNB) performed in the control group before induction of general anesthesia and surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in Post anesthesia care unit (PACU) and maintained for 48h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNB plus CFNB | Procedure | A single shot sciatic nerve block (SNB) is performed with 25 ml of 0.2% ropivacaine before surgery in addition to an isolated continuous femoral nerve block (CFNB) in the control group |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scores (VAS) - Pain Scores Measured in mm (0-100) | Pain scores measured by Visual Analogue Score (VAS) scale at 15-30min after Post anesthesia care unit (PACU) arrival VAS is a 100mm scale to measure pain. 0mm - no pain 100mm - worst possible pain | 15-30 min after arrival on post anesthesia care unit (PACU) |
| VAS Results - Pain Measured in mm (0-100) | VAS pain scores are measured by blinded investigators 12h after surgery . VAS scale: 0 - no pain 100 - worst possible pain | 12h after surgery |
| VAS Results - Pain Scores Measured in mm (0-100) | VAS pain scores are measured by blinded investigators 24h after surgery . VAS scale: 0 - no pain 100 - worst possible pain | 24h after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction With Anesthesia Technique in Each Arm of the Study | Satisfaction with the anesthesia technique using a categorical scale with three levels: Bad Reasonable Good/Very Good A Fisher's Exact test is made to asses any differences in the distribution of patients in each arm to each level of the categorical scale | 1 month after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raul MS Carvalho, MD | Centro Hospitalar do Porto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar do Porto, Serviço de Anestesia | Porto | Porto District | 4099-001 | Portugal |
Patients were excluded before randomization if refuse, could not use Visual Analogue Scale (VAS) scale, had contraindications for any of the components of the anesthesia protocol or, anesthesiologist was not expert in peripheral blocks
April 2011-February 2012. Consecutive patients for total knee arthroplasty at Orthopedic Department, Centro Hospitalar do Porto
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Femoral Nerve Block (CFNB) | A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h |
| FG001 | Single Shot Sciatic Nerve Block (SNB) | A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Femoral Nerve Block (CFNB) | A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h |
| BG001 | Single Shot Sciatic Nerve Block (SNB) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Visual Analogue Scores (VAS) - Pain Scores Measured in mm (0-100) | Pain scores measured by Visual Analogue Score (VAS) scale at 15-30min after Post anesthesia care unit (PACU) arrival VAS is a 100mm scale to measure pain. 0mm - no pain 100mm - worst possible pain | Participants were analyzed in an Intention to treat (ITT) manner. All randomized subjects (25 in each arm) completed the protocol so all were included for analysis as planned. | Posted | Mean | Standard Deviation | units on a scale | 15-30 min after arrival on post anesthesia care unit (PACU) |
|
24h
Motor block, paresthesias, falls or serious nausea and vomiting were monitored
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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 | Continuous Femoral Nerve Block (CFNB) | A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h |
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Difficulties in contacting patients by phone and getting reliable answers limit the value of the patient satisfaction parameter.
No analysis was made on the effect of nerve blocks on rehabilitation
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Raul Carvalho | Centro Hospitalar do Porto | +351226176114 | raul@meo.pt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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|
| CFNB | Procedure | A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before induction of general anesthesia and surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in post anesthesia care unit (PACU) and maintained for 48h |
|
|
A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Single Shot Sciatic Nerve Block (SNB) | A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group |
|
|
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| Secondary | Satisfaction With Anesthesia Technique in Each Arm of the Study | Satisfaction with the anesthesia technique using a categorical scale with three levels: Bad Reasonable Good/Very Good A Fisher's Exact test is made to asses any differences in the distribution of patients in each arm to each level of the categorical scale | Analysis was performed on Participants available for telephone contact one month after surgery and was made per protocol. | Posted | Number | participants | 1 month after surgery |
|
|
|
|
| Primary | VAS Results - Pain Measured in mm (0-100) | VAS pain scores are measured by blinded investigators 12h after surgery . VAS scale: 0 - no pain 100 - worst possible pain | All 25 patients in each arm completed the protocol. Analysis was made in an ITT manner. | Posted | Mean | Standard Deviation | units on a scale | 12h after surgery |
|
|
|
|
| Primary | VAS Results - Pain Scores Measured in mm (0-100) | VAS pain scores are measured by blinded investigators 24h after surgery . VAS scale: 0 - no pain 100 - worst possible pain | In the CFNB group 2 patients did not complete the protocol. Analysis was made in an ITT manner and Last Observational Carried Forward (LOCF) was the imputation technique used. In the SNB group, all 25 patients completed the protocol | Posted | Mean | Standard Deviation | units on a scale | 24h after surgery |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Single Shot Sciatic Nerve Block (SNB) | A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group | 0 | 25 | 0 | 25 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| Good/Very Good |
|