Popliteal Plexus BlockPhase 4NCT03198403
The Effect of Popliteal Plexus Block on Pain After Total Knee Arthroplasty
A Phase 4 study testing Bupivacaine-epinephrine in people with Popliteal Plexus Block and Total Knee Arthroplasty, run by Regionshospitalet Silkeborg at 1 site in Denmark.
Trial summary
The study aims to investigate the effect of the Popliteal plexus block (PPB) on postoperative pain after total knee arthroplasty Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Popliteal Plexus Block, Total Knee Arthroplasty
- What is being tested?
- Bupivacaine-epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2017to 28 Sep 2017
- 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
- patients undergoing total knee arthroplasty in spinal anesthesia
- age > or = 18 years
- American Society of Anesthesiologists (ASA) status I-III
- Informed consent
Who cannot join
- Patients unable to cooperate
- Patients not able to speak Danish
- Pregnancy
- Contraindication towards ana Medical product used in the study
- Preoperatively reduced sensation on the medial and lateral part of the lower leg
- Patients with diabetic requiring Medical treatment
- Preoperative daily intake of opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty
The study aims to investigate the effect of the Popliteal plexus block (PPB) on postoperative pain after total knee arthroplasty
Read the detailed description
Cadaver dissection studies have shown a spread of dye to the popliteal fossa and colored the popliteal plexus by injecting in the distal part of the adductor Canal.
The popliteal plexus is formed by contribution from the tibial and the obturator nerves.
Investigators hypothesized that a PPB may reduce postoperative pain after total knee arthroplasty.
- Conditions
- Popliteal Plexus Block, Total Knee Arthroplasty
- Being tested
- Bupivacaine-epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-epinephrineDrug
Popliteal plexus block with 10 mL of bupivacaine-epinephrine 5 mg/mL + 5 microgram/mL.
| Study group | Role | What they receive |
|---|---|---|
| Popliteal plexus block | Experimental | Patients with an FTB, reporting postoperative pain (NRS > 3) will have a popliteal plexus block Receives: Drug: Bupivacaine-epinephrine |
| No intervention | No intervention | Patients with postoperative pain NRS < or = 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with postoperative pain NRS
Evaluated as the percentage of patients with postoperative pain NRS >3, dropping in pain score to NRS = or < 3 after the PPB
Measured: 0 - 60 minutes
Secondary outcomes (6)
Percentage of patients having a femoral triangle block(FTB) reporting NRS > 3
Percentage of patients having a FTB, reporting postoperative pain NRS >3
Measured: Pain scores every 15 minutes (from end injection FTB to NRS>3 or 3 hours after full sensation of the leg)
Onset time of PPB
Time from end of injection of PPB to NRS = or < 3
Measured: NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)
Turn off time of spinal anesthesia
Time from arrival in PACU to normal cutaneous sensation (measured by a neuro-pen, sensation=point 2) on the lateral part of the thigh and lateral part of the lower leg
Measured: Time from arrival in PACU and during maximum 6 hours
Correlation between normal cutaneous sensation and developing of pain
Correlation between normal cutaneous sensation (measured by a neuro-pen, sensation=point 2) and developing of pain (NRS>3)
Measured: From arrival in PACU and during maximum 6 hours
The effect of the PPB on cutaneous sensation
Tested on the lateral part of the lower leg
Measured: NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)
The effect of the PPB on muscle strength of the foot
Dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer
Measured: Baseline and 1 hour after PPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Aug 2017
- Primary completion26 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Popliteal Plexus BlockStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Study
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Silkeborg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Runge, Regionshospitalet Silkeborg
- Investigators
- Charlotte Runge, MD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198403
- Sponsor's protocol ID
- 2017-001644-35
- Other IDs
- 2017
- Status last verified
- Sep 2017
- First submitted
- 20 Jun 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03198403
- Acronym / sponsor ID
- 2017-001644-35
- Conditions
- Popliteal Plexus Block, Total Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Regionshospitalet SilkeborgUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 26 Jun 2017 (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.
The study aims to investigate the effect of the Popliteal plexus block (PPB) on postoperative pain after total knee arthroplasty
Detailed description
Cadaver dissection studies have shown a spread of dye to the popliteal fossa and colored the popliteal plexus by injecting in the distal part of the adductor Canal.
The popliteal plexus is formed by contribution from the tibial and the obturator nerves.
Investigators hypothesized that a PPB may reduce postoperative pain after total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Popliteal plexus block | Experimental | Drug: Bupivacaine-epinephrinePatients with an FTB, reporting postoperative pain (NRS > 3) will have a popliteal plexus block |
| No intervention | No intervention | –Patients with postoperative pain NRS < or = 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients undergoing total knee arthroplasty in spinal anesthesia
- age > or = 18 years
- American Society of Anesthesiologists (ASA) status I-III
- Informed consent
Key exclusion criteria (7 listed)
- Patients unable to cooperate
- Patients not able to speak Danish
- Pregnancy
- Contraindication towards ana Medical product used in the study
- Preoperatively reduced sensation on the medial and lateral part of the lower leg
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 |
|---|---|---|
| Bupivacaine-epinephrinePopliteal plexus block with 10 mL of bupivacaine-epinephrine 5 mg/mL + 5 microgram/mL. | Drug | Popliteal plexus block |
Primary outcome
The percentage of patients with postoperative pain NRS
Time frame: 0 - 60 minutes
Evaluated as the percentage of patients with postoperative pain NRS >3, dropping in pain score to NRS = or < 3 after the PPB
6 secondary outcomes
Percentage of patients having a femoral triangle block(FTB) reporting NRS > 3
Time frame: Pain scores every 15 minutes (from end injection FTB to NRS>3 or 3 hours after full sensation of the leg)
Onset time of PPB
Time frame: NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)
Turn off time of spinal anesthesia
Time frame: Time from arrival in PACU and during maximum 6 hours
Correlation between normal cutaneous sensation and developing of pain
Time frame: From arrival in PACU and during maximum 6 hours
The effect of the PPB on cutaneous sensation
Time frame: NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)
The effect of the PPB on muscle strength of the foot
Time frame: Baseline and 1 hour after PPB
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 29 Sep 2017.
Related trials for Popliteal Plexus Block
Not yet recruiting
A Randomized Comparison of the Efficacy of the IPACK Block Versus the Popliteal Plexus Block for Posterior Knee Analgesia, in Patients Undergoing a Total Knee Arthroplasty and Receiving a Continuous Distal Femoral Triangle Block
Osteoarthritis, Knee, Postoperative Pain
Recruiting
Comparison of Distal IPACK and Popliteal Plexus Block Combined With Femoral Triangle Block After Total Knee Arthroplasty
Osteo Arthritis of the Knee
Active, not recruitingPhase 1/2
Efficacy of Non-weight Based, Low Dose Dex-Dex Adjuncts in Prolonging Peripheral Nerve Blocks
Postoperative Pain, Nausea and Vomiting, Postoperative
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.
Charlotte Runge, MD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine-epinephrine in people with Popliteal Plexus Block and Total Knee Arthroplasty, run by Regionshospitalet Silkeborg at 1 site in Denmark.
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 7 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 29 Sep 2017. 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 Denmark. 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.
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?
The percentage of patients with postoperative pain NRS (time frame: 0 - 60 minutes). 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 29 Sep 2017.