The Effect of Popliteal Plexus Block on Pain After Total Knee Arthroplasty
1 other identifier
interventional
17
1 country
1
Brief Summary
The study aims to investigate the effect of the Popliteal plexus block (PPB) on postoperative pain after total knee arthroplasty
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 26, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2017
CompletedSeptember 29, 2017
September 1, 2017
2 months
June 20, 2017
September 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
0 - 60 minutes
Secondary Outcomes (6)
Percentage of patients having a femoral triangle block(FTB) reporting NRS > 3
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
NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)
Turn off time of spinal anesthesia
Time from arrival in PACU and during maximum 6 hours
Correlation between normal cutaneous sensation and developing of pain
From arrival in PACU and during maximum 6 hours
The effect of the PPB on cutaneous sensation
NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)
- +1 more secondary outcomes
Study Arms (2)
Popliteal plexus block
EXPERIMENTALPatients with an FTB, reporting postoperative pain (NRS \> 3) will have a popliteal plexus block
No intervention
NO INTERVENTIONPatients with postoperative pain NRS \< or = 3
Interventions
Popliteal plexus block with 10 mL of bupivacaine-epinephrine 5 mg/mL + 5 microgram/mL.
Eligibility Criteria
You may qualify if:
- patients undergoing total knee arthroplasty in spinal anesthesia
- age \> or = 18 years
- American Society of Anesthesiologists (ASA) status I-III
- Informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Silkeborg Regionalhospital
Silkeborg, 8600, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Charlotte Runge, MD
University of Aarhus
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant anesthetist, Principal investigator
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 26, 2017
Study Start
August 1, 2017
Primary Completion
September 26, 2017
Study Completion
September 28, 2017
Last Updated
September 29, 2017
Record last verified: 2017-09