Knee Arthroplasty, TotalPhase 4NCT02465827
Ultrasound-guided Selective Blockade of the Saphenous and Obturator Nerves Following Total Knee Arthroplasty
A Phase 4 study testing nerve block with ropivacaine, nerve block with ropivacaine and with saline and nerve block with saline in people with Knee Arthroplasty, Total, run by Bispebjerg Hospital.
Trial summary
The investigators aimed to evaluate the efficacy of selective low volume ultrasound-guided blockades of the saphenous and obturator nerves on dynamic and rest pain 24-hours post-operatively for patients undergoing unilateral primary total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- nerve block with ropivacaine, nerve block with ropivacaine and with saline and nerve block with saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 2015
- Phase
- Phase 4
- 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
- American Society of Anesthesiologists' physical classification I-III
- Age ≥ 18 years undergoing primary unilateral total knee arthroplasty
Who cannot join
- Inability to cooperate
- Inability to speak and understand Danish
- Allergy to any drugs used in the study
- Drug or alcohol abuse
- Pregnancy or nursing
- Opioid abusers
About this study
Official title: Selective Blocks for Total Knee Arthroplasty
The investigators aimed to evaluate the efficacy of selective low volume ultrasound-guided blockades of the saphenous and obturator nerves on dynamic and rest pain 24-hours post-operatively for patients undergoing unilateral primary total knee arthroplasty.
Read the detailed description
A femoral nerve block is the recommended strategy in many surgical centers to supplement multimodal analgesic regime following total knee arthroplasty (TKA) (i.e. both for spinal and general anesthesia). However, a femoral nerve block will often result in quadriceps paralysis, and this will increase the risk for the patient to fall as long as the femoral block have effect. Thus, the search for sensory nerve blocks to stop pain after TKA is a very interesting topic. The saphenous nerve is a purely sensory nerve, and the posterior branch of the obturator nerve is a mixed nerve, where the motor component only affects part of the adductor major muscle.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- nerve block with ropivacaine, nerve block with ropivacaine and with saline, nerve block with saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve block with ropivacaineDrug
Also called Saphenous and obturator nerve block with ropivacaine
Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with ropivacaine 0.75% for both nerve branches
nerve block with ropivacaine and with salineDrug
Also called Saph block with ropivacaine and obtur block with saline
nerve blocks of the saphenous nerve with ropivacaine 0.75% and obturator nerve, posterior branch with saline
nerve block with salineDrug
Also called saphenous and obturator nerve block with saline
Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with saline for both nerve branches
| Study group | Role | What they receive |
|---|---|---|
| Saphenous and obturator nerve block | Active comparator | 5 ml of ropivacaine 0.75% for the saphenous nerve and 10 ml of ropivacaine 0,75% for the obturator nerve block.
Ropivacaine 0.75% for nerve blockades for both nerves mentioned. Receives: Drug: nerve block with ropivacaine |
| Saphenous nerve block | Active comparator | 5 ml of ropivacaine 0.75% for the saphenous nerve and 10 ml of isotonic saline for the obturator nerve block.
Ropivacaine 0.75% for the saphenous nerve block and saline for the obturator nerve block Receives: Drug: nerve block with ropivacaine and with saline |
| Placebo nerve block | Placebo comparator | 5 ml of isotonic saline for the saphenous nerve and 10 ml of isotonic saline for the obturator nerve block.
Saline for nerve blockades for both nerves mentioned. Receives: Drug: nerve block with saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic pain (pain upon movement) quantified as area-under-the-curve (AUC) 24-hours post-operatively
NRS 0-10
Measured: 24 hours
Secondary outcomes (6)
Pain at rest quantified as area-under-the-curve (AUC) 24-hours post-operatively
NRS 0-10
Measured: 24 hours
Total opioid consumption
mg
Measured: 24 hours
Nausea and vomiting
NRS 0-10
Measured: 24 hours
Time to first mobilization
hours
Measured: 24 hours
Length of stay in recovery and hospital
hours
Measured: 72 hours
Number of clinical complications
total number
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Borglum Neimann, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465827
- Sponsor's protocol ID
- BispebjergH
- Status last verified
- Jun 2015
- First submitted
- 2 Jun 2015
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Blocks for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02465827
- Acronym / sponsor ID
- BispebjergH
- Conditions
- Knee Arthroplasty, Total
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 9 Jun 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 investigators aimed to evaluate the efficacy of selective low volume ultrasound-guided blockades of the saphenous and obturator nerves on dynamic and rest pain 24-hours post-operatively for patients undergoing unilateral primary total knee arthroplasty.
Detailed description
A femoral nerve block is the recommended strategy in many surgical centers to supplement multimodal analgesic regime following total knee arthroplasty (TKA) (i.e. both for spinal and general anesthesia). However, a femoral nerve block will often result in quadriceps paralysis, and this will increase the risk for the patient to fall as long as the femoral block have effect. Thus, the search for sensory nerve blocks to stop pain after TKA is a very interesting topic. The saphenous nerve is a purely sensory nerve, and the posterior branch of the obturator nerve is a mixed nerve, where the motor component only affects part of the adductor major muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saphenous and obturator nerve block | Active comparator | Drug: nerve block with ropivacaine5 ml of ropivacaine 0.75% for the saphenous nerve and 10 ml of ropivacaine 0,75% for the obturator nerve block. Ropivacaine 0.75% for nerve blockades for both nerves mentioned. |
| Saphenous nerve block | Active comparator | Drug: nerve block with ropivacaine and with saline5 ml of ropivacaine 0.75% for the saphenous nerve and 10 ml of isotonic saline for the obturator nerve block. Ropivacaine 0.75% for the saphenous nerve block and saline for the obturator nerve block |
| Placebo nerve block | Placebo comparator | Drug: nerve block with saline5 ml of isotonic saline for the saphenous nerve and 10 ml of isotonic saline for the obturator nerve block. Saline for nerve blockades for both nerves mentioned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists' physical classification I-III
- Age ≥ 18 years undergoing primary unilateral total knee arthroplasty
Key exclusion criteria (6 listed)
- Inability to cooperate
- Inability to speak and understand Danish
- Allergy to any drugs used in the study
- Drug or alcohol abuse
- Pregnancy or nursing
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 |
|---|---|---|
| nerve block with ropivacaineAlso: Saphenous and obturator nerve block with ropivacaineUltrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with ropivacaine 0.75% for both nerve branches | Drug | Saphenous and obturator nerve block |
| nerve block with ropivacaine and with salineAlso: Saph block with ropivacaine and obtur block with salinenerve blocks of the saphenous nerve with ropivacaine 0.75% and obturator nerve, posterior branch with saline | Drug | Saphenous nerve block |
| nerve block with salineAlso: saphenous and obturator nerve block with salineUltrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with saline for both nerve branches | Drug | Placebo nerve block |
Primary outcome
Dynamic pain (pain upon movement) quantified as area-under-the-curve (AUC) 24-hours post-operatively
Time frame: 24 hours
NRS 0-10
6 secondary outcomes
Pain at rest quantified as area-under-the-curve (AUC) 24-hours post-operatively
Time frame: 24 hours
Total opioid consumption
Time frame: 24 hours
Nausea and vomiting
Time frame: 24 hours
Time to first mobilization
Time frame: 24 hours
Length of stay in recovery and hospital
Time frame: 72 hours
Number of clinical complications
Time frame: 72 hours
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 9 Jun 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nerve block with ropivacaine, nerve block with ropivacaine and with saline and nerve block with saline in people with Knee Arthroplasty, Total, run by Bispebjerg Hospital.
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 9 Jun 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dynamic pain (pain upon movement) quantified as area-under-the-curve (AUC) 24-hours post-operatively (time frame: 24 hours). 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 9 Jun 2015.