Postoperative PainNCT03698006
Selective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery
A study testing Ropivacaine 0.5% Injectable Solution and Ropivacaine 0.2% Injectable Solution in people with Postoperative Pain and Knee Osteoarthritis, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Patient suffer from moderate posterior knee pain after TKA despite injection of local anesthetic around the femoral or saphenous nerves. Indeed, the posterior part of the knee is innervated by the sciatic nerve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Knee Osteoarthritis
- What is being tested?
- Ropivacaine 0.5% Injectable Solution and Ropivacaine 0.2% Injectable Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Feb 2021to 30 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for a total knee arthroplasty under spinal block.
- Patient with a weight above 40kg.
Who cannot join
- Patient with ASA IV status.
- Contraindication to spinal block, or peripheral nerve blocks.
- Neurological deficit of the lower limb.
- Patient with renal dysfunction.
- Patient with chronic pain, opioid consumption or alcohol consumption.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Pain Control After Prothetic Knee Surgery Either by Selective Tibial Nerve Block Versus Local Infiltration Analgesia
Patient suffer from moderate posterior knee pain after TKA despite injection of local anesthetic around the femoral or saphenous nerves. Indeed, the posterior part of the knee is innervated by the sciatic nerve. This nerve is not routinely blocked as clinicians fear to produce a motor block of the leg that might impair the postoperative assessment. An analgesic alternative is the infiltration of the knee with local anesthetics performed by the surgeon. Recently a trial(1) demonstrated that a selective tibial nerve block provides an effective analgesia without a motor blockage when compared with a sciatic nerve block. The objective of this randomized controlled double-blinded trial is to assess whether a tibial nerve block is more effective for the postoperative pain than local infiltration analgesia when there are combined with an adductor canal block, without decreasing the functional parameters.
- Conditions
- Postoperative Pain, Knee Osteoarthritis
- Being tested
- Ropivacaine 0.5% Injectable Solution, Ropivacaine 0.2% Injectable Solution
- Medical subject headings
- Pain, Postoperative, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.5% Injectable SolutionDrug
Tibial nerve block with 10ml of Ropivacaine 0.5%
Ropivacaine 0.2% Injectable SolutionDrug
Infiltration with 25ml of Ropivacaine 0.2% in the posterior knee capsule
| Study group | Role | What they receive |
|---|---|---|
| Tibial nerve block | Experimental | Adductor canal and tibial nerve blocks performed by the anesthetist under ultrasound guidance before spinal block. Receives: Drug: Ropivacaine 0.5% Injectable Solution |
| Local infiltration analgesia | Active comparator | Adductor canal block by the anesthetist under ultrasound guidance before spinal block. Infiltration of the knee by the surgeon with local anesthetic at the end of the surgery. Receives: Drug: Ropivacaine 0.2% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption (mg)
Measured: 24 hours postoperatively
Secondary outcomes (11)
Total morphine consumption (mg)
Measured: 2 hours, 48 hours and 72 hours postoperatively
Analgesic duration (minutes)
Time from the block to the first analgesic request
Measured: Postoperative day 0
Pain scores (numeric rating scale, 0-10) at rest and on movement
0= no pain, 10=the worst pain imaginable
Measured: 2 hours, 24 hours, 48 hours and 72 hours postoperatively
Rate of postoperative nausea and vomiting
Yes/No
Measured: 2 hours, 24 hours, 48 hours and 72 hours postoperatively
Rate of prurit
Yes/No
Measured: 2 hours, 24 hours, 48 hours and 72 hours postoperatively
Active flexion
Flexion of the knee by the patient measured in degrees
Measured: 24hours, 48hours and 72hours postoperatively
Passive flexion
Flexion of the knee by physiotherapist measured in degrees
Measured: 24hours, 48hours and 72hours postoperatively
Quadriceps muscle strength (numeric scale, 1-5)
1=no contraction, 5=normal strength
Measured: 24hours, 48hours and 72hours postoperatively
Distance walked (meters)
Measured: 24hours, 48hours and 72hours postoperatively
Complication of tibial nerve block
Intravascular injection/hematoma/infection/Common peroneal nerve block
Measured: up to 1 week
Length of stay in hospital
Days
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start12 Feb 2021
- Primary completion31 Jan 2022
- Study completion30 Jun 2022
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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698006
- Sponsor's protocol ID
- CER 2018-01080
- Status last verified
- Oct 2022
- First submitted
- 2 Oct 2018
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sinha SK, Abrams JH, Arumugam S, D'Alessio J, Freitas DG, Barnett JT, Weller RS. Femoral nerve block with selective tibial nerve block provides effective analgesia without foot drop after total knee arthroplasty: a prospective, randomized, observer-blinded study. Anesth Analg. 2012 Jul;115(1):202-6. doi: 10.1213/ANE.0b013e3182536193. Epub 2012 Apr 27.
PubMed 22543069
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Pain Control After Prothetic Knee Surgery Either by Selective Tibial Nerve Block Versus Local Infiltration Analgesia
- ClinicalTrials.gov ID
- NCT03698006
- Acronym / sponsor ID
- CER 2018-01080
- Conditions
- Postoperative Pain, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 5 Oct 2018 (actual)
- 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.
Patient suffer from moderate posterior knee pain after TKA despite injection of local anesthetic around the femoral or saphenous nerves. Indeed, the posterior part of the knee is innervated by the sciatic nerve. This nerve is not routinely blocked as clinicians fear to produce a motor block of the leg that might impair the postoperative assessment. An analgesic alternative is the infiltration of the knee with local anesthetics performed by the surgeon. Recently a trial(1) demonstrated that a selective tibial nerve block provides an effective analgesia without a motor blockage when compared with a sciatic nerve block. The objective of this randomized controlled double-blinded trial is to assess whether a tibial nerve block is more effective for the postoperative pain than local infiltration analgesia when there are combined with an adductor canal block, without decreasing the functional parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tibial nerve block | Experimental | Drug: Ropivacaine 0.5% Injectable SolutionAdductor canal and tibial nerve blocks performed by the anesthetist under ultrasound guidance before spinal block. |
| Local infiltration analgesia | Active comparator | Drug: Ropivacaine 0.2% Injectable SolutionAdductor canal block by the anesthetist under ultrasound guidance before spinal block. Infiltration of the knee by the surgeon with local anesthetic at the end of the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient scheduled for a total knee arthroplasty under spinal block.
- Patient with a weight above 40kg.
Key exclusion criteria (6 listed)
- Patient with ASA IV status.
- Contraindication to spinal block, or peripheral nerve blocks.
- Neurological deficit of the lower limb.
- Patient with renal dysfunction.
- Patient with chronic pain, opioid consumption or alcohol consumption.
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 |
|---|---|---|
| Ropivacaine 0.5% Injectable SolutionTibial nerve block with 10ml of Ropivacaine 0.5% | Drug | Tibial nerve block |
| Ropivacaine 0.2% Injectable SolutionInfiltration with 25ml of Ropivacaine 0.2% in the posterior knee capsule | Drug | Local infiltration analgesia |
Primary outcome
Total morphine consumption (mg)
Time frame: 24 hours postoperatively
11 secondary outcomes
Total morphine consumption (mg)
Time frame: 2 hours, 48 hours and 72 hours postoperatively
Analgesic duration (minutes)
Time frame: Postoperative day 0
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time frame: 2 hours, 24 hours, 48 hours and 72 hours postoperatively
Rate of postoperative nausea and vomiting
Time frame: 2 hours, 24 hours, 48 hours and 72 hours postoperatively
Rate of prurit
Time frame: 2 hours, 24 hours, 48 hours and 72 hours postoperatively
Active flexion
Time frame: 24hours, 48hours and 72hours postoperatively
Passive flexion
Time frame: 24hours, 48hours and 72hours postoperatively
Quadriceps muscle strength (numeric scale, 1-5)
Time frame: 24hours, 48hours and 72hours postoperatively
Distance walked (meters)
Time frame: 24hours, 48hours and 72hours postoperatively
Complication of tibial nerve block
Time frame: up to 1 week
Length of stay in hospital
Time frame: up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Background: PubMed 22543069Sinha SK, Abrams JH, Arumugam S, D'Alessio J, Freitas DG, Barnett JT, Weller RS. Femoral nerve block with selective tibial nerve block provides effective analgesia without foot drop after total knee arthroplasty: a prospective, randomized, observer-blinded study. Anesth Analg. 2012 Jul;115(1):202-6. doi: 10.1213/ANE.0b013e3182536193. Epub 2012 Apr 27.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine 0.5% Injectable Solution and Ropivacaine 0.2% Injectable Solution in people with Postoperative Pain and Knee Osteoarthritis, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 2 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: finished, as of the sponsor's last update on 10 Oct 2022. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total morphine consumption (mg) (time frame: 24 hours postoperatively). 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 NCT03698006, 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 10 Oct 2022.