Neuromuscular BlockadeNCT02387021
Continuous Adductor Canal Block for Total Knee Arthroplasty Analgesia
A study testing Continuous femoral nerve block, Continuous adductor canal block and infragluteal Sciatic nerve block in people with Neuromuscular Blockade and Pain Management, run by Institut Kassab d'Orthopédie.
Trial summary
The purpose of the study is to determine whether the association of sciatic nerve block to continuous adductor canal block is effective in the treatment of total knee arthroplasty post operative pain . Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neuromuscular Blockade, Pain Management
- What is being tested?
- Continuous femoral nerve block, Continuous adductor canal block and infragluteal Sciatic nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective unilateral TKA,
- Planned continuous spinal anesthesia ,
- Ability to follow study protocol,
- American Society of Anesthesiologists class 1 to 3.
Who cannot join
- Contraindication for neuraxial anesthetic,
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months),
- Hypersensitivity and/or allergies to any of the study medications,
- Intraoperative use of volatile anesthetics,
- Preexisting neuropathy on the operative limb,
- Contraindications to a femoral, adductor canal or Tibial nerve block.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Comparison Between Continuous Femoral Nerve Block and the Association of Adductor Canal Block and Sciatic Nerve Block in Total Knee Arthroplasty.
The purpose of the study is to determine whether the association of sciatic nerve block to continuous adductor canal block is effective in the treatment of total knee arthroplasty post operative pain .
- Conditions
- Neuromuscular Blockade, Pain Management
- Being tested
- Continuous femoral nerve block, Continuous adductor canal block, infragluteal Sciatic nerve block, Ropivacaine 0.2%, Saline
- Keywords
- analgesia, nerve block, Total knee replacement
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous femoral nerve blockProcedure or surgery
Continuous adductor canal blockProcedure or surgery
infragluteal Sciatic nerve blockProcedure or surgery
Ropivacaine 0.2%Drug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Continous femoral nerve block | Active comparator | Patients will receive ultrasound-guided (USG) continuous femoral nerve block with 20 ml ropivacaine 0.2% and USG Continuous adductor canal block with 20 ml of saline and USG infragluteal SNB with 20 ml of saline . Receives: Procedure: Continuous femoral nerve block; Procedure: Continuous adductor canal block; Procedure: infragluteal Sciatic nerve block; Drug: Ropivacaine 0.2%; Drug: Saline |
| Continuous adductor canal block | Experimental | Patients will receive ultrasound-guided continuous adductor canal block with 20 ml ropivacaine 0.2% and USG infragluteal SNB with 20 ml ropivacaine 0.2% and USG continuous FNB with 20 ml of saline . Receives: Procedure: Continuous femoral nerve block; Procedure: Continuous adductor canal block; Procedure: infragluteal Sciatic nerve block; Drug: Ropivacaine 0.2%; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid-consumption
Cumulative opioid consumption : converting oral, intravenous, and patient-controlled analgesia PCA opioid to morphine equivalent
Measured: 8 hours postoperative
Secondary outcomes (7)
NRS pain score at rest
NRS pain scores determined by patient interview, using the standard NRS of 0 to 10 scale at rest.
Measured: 0,1,2,4,6,8,12,24 and 48 hours postoperative
NRS pain score during movement
NRS pain scores determined by patient interview, using the standard NRS of 0 to 10 scale, during physiotherapy.
Measured: 0,1,2,4,6,8,12,24 and 48 hours postoperative
NRS pain score after 10 meters of walk or maximum walked distance
NRS pain scores determined by patient interview, using the standard NRS of 0 to 10 scale after 10 meters walk (if enable after maximum walked distance).
Measured: 8, 24 and 48 hours postoperative
Ability to walk
The ability of the patient to stand up and walk 3 meters.
Measured: 8, 24 and 48 hours postoperative
TUG Test
The TUG test measures the time it takes a patient to stand up from a chair, walk a distance of 3 m, and return to the chair
Measured: 8, 24 and 48 hours postoperative
The 10-m walk test
time it takes the patient to walk a distance of 10 m as quickly as possible
Measured: 8, 24 and 48 hours postoperative
patient satisfaction
patient interviewed, using a scale of 0-10, 0 not satisfied and 10 being the most satisfied
Measured: 8, 24 and 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Kassab d'Orthopédie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rais Karim, Institut Kassab d'Orthopédie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387021
- Sponsor's protocol ID
- P-2015002/AR
- Status last verified
- Mar 2015
- First submitted
- 4 Mar 2015
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
PubMed 24401769
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison Between Continuous Femoral Nerve Block and the Association of Adductor Canal Block and Sciatic Nerve Block in Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT02387021
- Acronym / sponsor ID
- P-2015002/AR
- Conditions
- Neuromuscular Blockade, Pain Management
- Keywords
- analgesia, nerve block, Total knee replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institut Kassab d'OrthopédieUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Not posted in the source record
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 the study is to determine whether the association of sciatic nerve block to continuous adductor canal block is effective in the treatment of total knee arthroplasty post operative pain .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continous femoral nerve block | Active comparator | Procedure: Continuous femoral nerve block, Procedure: Continuous adductor canal block, Procedure: infragluteal Sciatic nerve block, Drug: Ropivacaine 0.2%, Drug: SalinePatients will receive ultrasound-guided (USG) continuous femoral nerve block with 20 ml ropivacaine 0.2% and USG Continuous adductor canal block with 20 ml of saline and USG infragluteal SNB with 20 ml of saline . |
| Continuous adductor canal block | Experimental | Procedure: Continuous femoral nerve block, Procedure: Continuous adductor canal block, Procedure: infragluteal Sciatic nerve block, Drug: Ropivacaine 0.2%, Drug: SalinePatients will receive ultrasound-guided continuous adductor canal block with 20 ml ropivacaine 0.2% and USG infragluteal SNB with 20 ml ropivacaine 0.2% and USG continuous FNB with 20 ml of saline . |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective unilateral TKA,
- Planned continuous spinal anesthesia ,
- Ability to follow study protocol,
- American Society of Anesthesiologists class 1 to 3.
Key exclusion criteria (6 listed)
- Contraindication for neuraxial anesthetic,
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months),
- Hypersensitivity and/or allergies to any of the study medications,
- Intraoperative use of volatile anesthetics,
- Preexisting neuropathy on the operative limb,
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 |
|---|---|---|
| Continuous femoral nerve block | Procedure or surgery | Continous femoral nerve block, Continuous adductor canal block |
| Continuous adductor canal block | Procedure or surgery | Continous femoral nerve block, Continuous adductor canal block |
| infragluteal Sciatic nerve block | Procedure or surgery | Continous femoral nerve block, Continuous adductor canal block |
| Ropivacaine 0.2% | Drug | Continous femoral nerve block, Continuous adductor canal block |
| Saline | Drug | Continous femoral nerve block, Continuous adductor canal block |
Primary outcome
Total Opioid-consumption
Time frame: 8 hours postoperative
Cumulative opioid consumption : converting oral, intravenous, and patient-controlled analgesia PCA opioid to morphine equivalent
7 secondary outcomes
NRS pain score at rest
Time frame: 0,1,2,4,6,8,12,24 and 48 hours postoperative
NRS pain score during movement
Time frame: 0,1,2,4,6,8,12,24 and 48 hours postoperative
NRS pain score after 10 meters of walk or maximum walked distance
Time frame: 8, 24 and 48 hours postoperative
Ability to walk
Time frame: 8, 24 and 48 hours postoperative
TUG Test
Time frame: 8, 24 and 48 hours postoperative
The 10-m walk test
Time frame: 8, 24 and 48 hours postoperative
patient satisfaction
Time frame: 8, 24 and 48 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.
- Background: PubMed 24401769Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous femoral nerve block, Continuous adductor canal block and infragluteal Sciatic nerve block in people with Neuromuscular Blockade and Pain Management, run by Institut Kassab d'Orthopédie.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karim Raies, M.D (+21655208602, karim.raies@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid-consumption (time frame: 8 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02387021, which also lists 1 linked publication.
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 12 Mar 2015.