Postoperative PainNCT01337115
Effect of a Sciatic Block (SNB) Combined With a Continuous Femoral Block (CFNB) on Pain Scores After Knee Arthroplasty
A study testing SNB plus CFNB and CFNB in people with Postoperative Pain, run by Centro Hospitalar do Porto at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- SNB plus CFNB and CFNB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- Apr 2011to Mar 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Unilateral total knee replacement
Who cannot join
- Contra-indication for general anesthesia
- Infection on puncture site
- Coagulation disorders
- Pre-existent neuropathies
- Allergies to local anesthetics, paracetamol, diclofenac and tramadol
- Severe dyspepsia
Show all 11Show fewer
- Less than 50kg weigh
- Body Mass Index (BMI) greater than 40
- American Society of Anesthesiologists (ASA) Physical Status 4 or 5
- Absence of capacity to use the Visual Analog Score (VAS) scale
- Refusal to give informed consent
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar do Porto, Serviço de Anestesia
Porto, Porto District, 4099-001
About this study
Official title: Effect of a Single Shot Sciatic Nerve Block (SNB) Combined With a Continuous Femoral Block (CFNB) on Pain Scores After Knee Arthroplasty. A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Postoperative Pain
- Being tested
- SNB plus CFNB, CFNB
- Keywords
- Postoperative pain, Knee arthroplasty, Peripheral nerve blocks, Sciatic nerve block, Femoral nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNB plus CFNBProcedure or surgery
Also called Peripheral nerve blocks, Local anesthetics, Ropivacaine, Femoral nerve block
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
CFNBProcedure or surgery
Also called Peripheral nerve blocks, Local anesthetics, Ropivacaine, Femoral nerve block
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: CFNB |
| 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 Receives: Procedure: SNB plus CFNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 24h after surgery
Secondary outcomes (1)
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
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2012
- Study completionMar 2012
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 Postoperative PainStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Porto
- Responsible party
- Principal investigator, Raul Carvalho, Centro Hospitalar do Porto
- Investigators
- Raul MS Carvalho, MD, Principal investigator, Centro Hospitalar do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337115
- Sponsor's protocol ID
- TA 007/11(004-DEFI/007-CES)
- Status last verified
- May 2012
- First submitted
- 15 Apr 2011
- Last updated
- 19 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Shot Sciatic Nerve Block (SNB) Combined With a Continuous Femoral Block (CFNB) on Pain Scores After Knee Arthroplasty. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01337115
- Acronym / sponsor ID
- TA 007/11(004-DEFI/007-CES)
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Knee arthroplasty, Peripheral nerve blocks, Sciatic nerve block, Femoral nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centro Hospitalar do PortoUniversity, hospital or other
- Collaborators
- Universidade do Porto
- Study start
- Apr 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Posted 19 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous femoral nerve block (CFNB) | Active comparator | Procedure: CFNBA 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 | Procedure: SNB plus CFNBA 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral total knee replacement
Key exclusion criteria (11 listed)
- Contra-indication for general anesthesia
- Infection on puncture site
- Coagulation disorders
- Pre-existent neuropathies
- Allergies to local anesthetics, paracetamol, diclofenac and tramadol
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 |
|---|---|---|
| SNB plus CFNBAlso: Peripheral nerve blocks, Local anesthetics, Ropivacaine, Femoral nerve blockA 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 | Procedure or surgery | Single shot SNB plus CFNB |
| CFNBAlso: Peripheral nerve blocks, Local anesthetics, Ropivacaine, Femoral nerve blockA 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 | Procedure or surgery | Continuous femoral nerve block (CFNB) |
Primary outcome
Visual Analogue Scores (VAS) - Pain Scores Measured in mm (0-100)
Time frame: 15-30 min after arrival on post anesthesia care unit (PACU)
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
VAS Results - Pain Measured in mm (0-100)
Time frame: 12h after surgery
VAS pain scores are measured by blinded investigators 12h after surgery . VAS scale: 0 - no pain 100 - worst possible pain
VAS Results - Pain Scores Measured in mm (0-100)
Time frame: 24h after surgery
VAS pain scores are measured by blinded investigators 24h after surgery . VAS scale: 0 - no pain 100 - worst possible pain
1 secondary outcome
Satisfaction With Anesthesia Technique in Each Arm of the Study
Time frame: 1 month after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Raul MS Carvalho, MD principal investigator
Centro Hospitalar do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNB plus CFNB and CFNB in people with Postoperative Pain, run by Centro Hospitalar do Porto at 1 site in Portugal.
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 11 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 19 Jun 2012. 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 Portugal. 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 19 Jun 2012). 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?
Visual Analogue Scores (VAS) - Pain Scores Measured in mm (0-100) (time frame: 15-30 min after arrival on post anesthesia care unit (PACU)). The study lists 3 primary outcomes in all. 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 19 Jun 2012.