Postoperative PainNCT05728294
Femoral or Sciatic Nerve Block to Provide Analgesia After Proximal Tibial Osteotomy
A study testing Femoral nerve block with ropivacaine 0.5%, 20 ml and Sciatic nerve block with ropivacaine 0.5%, 20 ml in people with Postoperative Pain, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Proximal tibial osteotomy is associated with moderate to severe postoperative pain. The proximal part of the tibia is innervated by branches from the femoral nerve anteriorly and the sciatic nerve posteriorly. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Femoral nerve block with ropivacaine 0.5%, 20 ml and Sciatic nerve block with ropivacaine 0.5%, 20 ml
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2019to 31 Mar 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- proximal tibial osteotomy
Who cannot join
- femoral or sciatic nerve deficit,
- pre-existing peripheral neuropathy,
- chronic pain diagnosis,
- pregnancy,
- identified contraindications to peripheral nerve block (e.g., local anesthetic allergy, coagulopathy, or infection at the block site).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Lausanne
Lausanne, Canton of Vaud, 1011
About this study
Proximal tibial osteotomy is associated with moderate to severe postoperative pain. The proximal part of the tibia is innervated by branches from the femoral nerve anteriorly and the sciatic nerve posteriorly. Little is known on the type of peripheral nerve block to perform so that optimal postoperative analgesia is provided with minimum impact on the motor function. This randomised controlled double-blinded trial tested the hypothesis that a femoral nerve block provides superior analgesia than a sciatic nerve block after proximal tibial osteotomy.
- Conditions
- Postoperative Pain
- Being tested
- Femoral nerve block with ropivacaine 0.5%, 20 ml, Sciatic nerve block with ropivacaine 0.5%, 20 ml
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve block with ropivacaine 0.5%, 20 mlProcedure or surgery
Femoral nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml
Sciatic nerve block with ropivacaine 0.5%, 20 mlProcedure or surgery
Sciatic nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml
| Study group | Role | What they receive |
|---|---|---|
| Femoral nerve block | Active comparator | Femoral nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL Receives: Procedure: Femoral nerve block with ropivacaine 0.5%, 20 ml |
| Sciatic nerve block | Experimental | Sciatic nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL Receives: Procedure: Sciatic nerve block with ropivacaine 0.5%, 20 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravenous morphine consumption
Intravenous morphine consumption (mg)
Measured: 24 hours after surgery
Secondary outcomes (11)
Intravenous morphine consumption
Intravenous morphine consumption (mg)
Measured: 2 hours after surgery
Intravenous morphine consumption
Intravenous morphine consumption (mg)
Measured: 48 hours after surgery
rest pain score
pain score at rest (visual analogue scale, 0-10)
Measured: 2 hours after surgery
rest pain score
pain score at rest (visual analogue scale, 0-10)
Measured: 24 hours after surgery
rest pain score
pain score at rest (visual analogue scale, 0-10)
Measured: 48 hours after surgery
dynamic pain score
pain score on movement (visual analogue scale, 0-10)
Measured: 2 hours after surgery
dynamic pain score
pain score on movement (visual analogue scale, 0-10)
Measured: 24 hours after surgery
dynamic pain score
pain score on movement (visual analogue scale, 0-10)
Measured: 48 hours after surgery
Rate of postoperative nausea and vomiting
number of events/total number of patients
Measured: 2 hours after surgery
Rate of postoperative nausea and vomiting
number of events/total number of patients
Measured: 24 hours after surgery
Rate of postoperative nausea and vomiting
number of events/total number of patients
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Feb 2019
- Primary completion31 Oct 2022
- Study completion31 Mar 2023
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
- Model description
- Two groups: femoral nerve block or sciatic nerve block with ropivacaine
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 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
- NCT05728294
- Sponsor's protocol ID
- 2018-01774
- Other IDs
- 2018
- Status last verified
- Apr 2023
- First submitted
- 19 Jan 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kull C, Martin R, Rossel JB, Nguyen A, Albrecht E. Femoral vs sciatic nerve block to provide analgesia after medial open wedge high tibial osteotomy in the setting of multimodal analgesia: A randomized, controlled, single-blinded trial. J Clin Anesth. 2024 May;93:111355. doi: 10.1016/j.jclinane.2023.111355. Epub 2023 Dec 21.
PubMed 38134484
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral or Sciatic Nerve Block to Provide Analgesia After Proximal Tibial Osteotomy
- ClinicalTrials.gov ID
- NCT05728294
- Acronym / sponsor ID
- 2018-01774
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 15 Feb 2023 (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.
Proximal tibial osteotomy is associated with moderate to severe postoperative pain. The proximal part of the tibia is innervated by branches from the femoral nerve anteriorly and the sciatic nerve posteriorly. Little is known on the type of peripheral nerve block to perform so that optimal postoperative analgesia is provided with minimum impact on the motor function. This randomised controlled double-blinded trial tested the hypothesis that a femoral nerve block provides superior analgesia than a sciatic nerve block after proximal tibial osteotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: femoral nerve block or sciatic nerve block with ropivacaine
| Arm | Type | Receives |
|---|---|---|
| Femoral nerve block | Active comparator | Procedure: Femoral nerve block with ropivacaine 0.5%, 20 mlFemoral nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL |
| Sciatic nerve block | Experimental | Procedure: Sciatic nerve block with ropivacaine 0.5%, 20 mlSciatic nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- proximal tibial osteotomy
Key exclusion criteria (5 listed)
- femoral or sciatic nerve deficit,
- pre-existing peripheral neuropathy,
- chronic pain diagnosis,
- pregnancy,
- identified contraindications to peripheral nerve block (e.g., local anesthetic allergy, coagulopathy, or infection at the block site).
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 |
|---|---|---|
| Femoral nerve block with ropivacaine 0.5%, 20 mlFemoral nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml | Procedure or surgery | Femoral nerve block |
| Sciatic nerve block with ropivacaine 0.5%, 20 mlSciatic nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml | Procedure or surgery | Sciatic nerve block |
Primary outcome
Intravenous morphine consumption
Time frame: 24 hours after surgery
Intravenous morphine consumption (mg)
11 secondary outcomes
Intravenous morphine consumption
Time frame: 2 hours after surgery
Intravenous morphine consumption
Time frame: 48 hours after surgery
rest pain score
Time frame: 2 hours after surgery
rest pain score
Time frame: 24 hours after surgery
rest pain score
Time frame: 48 hours after surgery
dynamic pain score
Time frame: 2 hours after surgery
dynamic pain score
Time frame: 24 hours after surgery
dynamic pain score
Time frame: 48 hours after surgery
Rate of postoperative nausea and vomiting
Time frame: 2 hours after surgery
Rate of postoperative nausea and vomiting
Time frame: 24 hours after surgery
Rate of postoperative nausea and vomiting
Time frame: 48 hours after surgery
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 21 Apr 2023.
- Derived from this study: PubMed 38134484Kull C, Martin R, Rossel JB, Nguyen A, Albrecht E. Femoral vs sciatic nerve block to provide analgesia after medial open wedge high tibial osteotomy in the setting of multimodal analgesia: A randomized, controlled, single-blinded trial. J Clin Anesth. 2024 May;93:111355. doi: 10.1016/j.jclinane.2023.111355. Epub 2023 Dec 21.
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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 Femoral nerve block with ropivacaine 0.5%, 20 ml and Sciatic nerve block with ropivacaine 0.5%, 20 ml in people with Postoperative Pain, 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 1 inclusion and 5 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 21 Apr 2023. 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?
Intravenous morphine consumption (time frame: 24 hours after surgery). 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 NCT05728294, 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 21 Apr 2023.