Popliteal Plexus Block for Total Knee Arthroplasty
Primary Purpose
Pain, Postoperative
Status
Terminated
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution
Sodium Chloride 0.9 %
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Arthroplasty, Replacement, Knee, Anesthetics, Local, Pain, Postoperative, Nerve Block, Bupivacaine, Epinephrine
Eligibility Criteria
Inclusion Criteria:
- Male or female at least 50 years of age at screening
- Scheduled to undergo primary total knee arthroplasty in spinal anesthesia
- Normal sensory function at the lateral part of the thigh and lower leg
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
- Able to provide informed consent
Exclusion Criteria:
- Unable to cooperate and follow the study protocol
- Communication problems
- Allergic towards any medical product administered in the study
- Diabetes requiring medical treatment
- Pregnancy (a pregnancy test will be conducted on all women of childbearing potential prior to inclusion in the study. A positive test result will result in exclusion from the study)
- Preoperative opioid treatment (dosed > once daily)
Sites / Locations
- Silkeborg Regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Popliteal Plexus Block
Placebo Popliteal Plexus Block
Arm Description
10 ml Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution
10 ml Sodium Chloride 0.9 %
Outcomes
Primary Outcome Measures
Success of the popliteal plexus block (PPB)
Success of the PPB is defined as the proportion of patients with significant postoperative pain (NRS > 3) after FTB, who drop in pain score to NRS ≤ 3 after PPB and maintain NRS ≤ 3 without any opioids until 60 minutes after PPB
Secondary Outcome Measures
Onset time of the PPB
The onset time is defined as the time from withdrawal of the block needle and until the patient reports NRS ≤ 3. The maximal onset time is defined as 60 minutes
The effect of the PPB on cutaneous sensation
Performed as a pinprick test on the lateral aspect of the lower leg. Sensation to pinprick is graded on a 3-point scale: 0 = no sensation, 1 = reduced sensation and 2 = normal sensation to pinprick compared to the contralateral side
The effect of PPB on isometric muscle strength of the he dorso- and plantar flexors of the ankle joint
Dorsal and plantar flexion of the foot is measured as the maximum voluntary isometric contraction (MVIC). During the test, a handheld dynamometer is kept immobile and the patient is asked to push against the dynamometer with maximal force and maintain this maximal pressure for 5 seconds. The MVIC is measured three times, separated by a 30-second pause, and the highest of the three MVIC values is registered
Opioid consumption from 0-4 hours
Registered from the electronic patient record
Opioid consumption from 4-24 hours
Registered from the electronic patient record
Pain scores (Numerical Rating Scale, NRS, 0-10 where 0 is "no pain" and 10 is "worst pain imaginable"
The patient is asked about the worst pain since last test time
Pain localization
Evaluated using a systematic questionnaire
The number of patients requiring a PPB
The number of patients experiencing NRS > 3 as a proportion of all patients with femoral triangle block (FTB)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03439787
Brief Title
Popliteal Plexus Block for Total Knee Arthroplasty
Official Title
The Effect of the Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty - a Randomized, Controlled, Double-blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Methodological problems/problems in the study design (competing pain and a placebo effect). No serious adverse events or other safety issues
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
August 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to assess the analgesic effect of the popliteal plexus block as a supplement to a femoral triangle block in patients undergoing total knee arthroplasty
Detailed Description
A femoral triangle block (FTB) effectively anesthetizes the anterior group of nerves innervating the knee (infrapatellar branch of the saphenous nerve, the medial femoral cutaneous nerve and the terminal branch of the medial vastus muscle nerve). However, the posterior group of nerves innervating the knee joint is not covered with an FTB, and therefore most patients complain of significant, opioid-requiring pain despite a successful FTB.
The posterior group consists of the popliteal plexus, which is derived from the tibial nerve and the posterior branch of the obturator nerve. The popliteal plexus is located in the popliteal fossa, where it entwines the popliteal artery and vein. Recent cadaver studies have suggested that an injection into the distal part of the adductor canal will spread to the popliteal fossa (PubMed Identifier (ID): 28937534; PubMed ID: 27442773).
This study aims to assess the analgesic effect of the popliteal plexus block (PPB) as a supplement to a femoral triangle block (FTB) after total knee arthroplasty (TKA).
In the study all patients will receive an FTB with 10 ml bupivacaine-epinephrine (0.5%-1:200,000) with the addition of 0.5 ml Dexamethasone (4 mg/ml).
All patients are postoperatively observed for the development of significant pain (NRS > 3) in the primary observation period (POP) defined as: a 3-hour observation period starting at the return of completely normal cutaneous sensation (lateral thigh and lateral side of the lower leg) after spinal anesthesia. If the patient reports pain (NRS > 3) in the POP, the patient will be randomized to the study treatment - a PPB with 10 ml bupivacaine-epinephrine or 10 ml saline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Arthroplasty, Replacement, Knee, Anesthetics, Local, Pain, Postoperative, Nerve Block, Bupivacaine, Epinephrine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, placebo-controlled, double-blinded design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Popliteal Plexus Block
Arm Type
Active Comparator
Arm Description
10 ml Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution
Arm Title
Placebo Popliteal Plexus Block
Arm Type
Placebo Comparator
Arm Description
10 ml Sodium Chloride 0.9 %
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution
Other Intervention Name(s)
Marcain-adrenaline
Intervention Description
10 ml
Intervention Type
Other
Intervention Name(s)
Sodium Chloride 0.9 %
Intervention Description
10 ml
Primary Outcome Measure Information:
Title
Success of the popliteal plexus block (PPB)
Description
Success of the PPB is defined as the proportion of patients with significant postoperative pain (NRS > 3) after FTB, who drop in pain score to NRS ≤ 3 after PPB and maintain NRS ≤ 3 without any opioids until 60 minutes after PPB
Time Frame
60 minutes after placement of the PPB
Secondary Outcome Measure Information:
Title
Onset time of the PPB
Description
The onset time is defined as the time from withdrawal of the block needle and until the patient reports NRS ≤ 3. The maximal onset time is defined as 60 minutes
Time Frame
The pain scores after PPB are evaluated every 5 minutes until 15 minutes after PPB and hereafter every 15 minutes until 60 minutes after PPB
Title
The effect of the PPB on cutaneous sensation
Description
Performed as a pinprick test on the lateral aspect of the lower leg. Sensation to pinprick is graded on a 3-point scale: 0 = no sensation, 1 = reduced sensation and 2 = normal sensation to pinprick compared to the contralateral side
Time Frame
Baseline and 2 hours after the placement of the PPB
Title
The effect of PPB on isometric muscle strength of the he dorso- and plantar flexors of the ankle joint
Description
Dorsal and plantar flexion of the foot is measured as the maximum voluntary isometric contraction (MVIC). During the test, a handheld dynamometer is kept immobile and the patient is asked to push against the dynamometer with maximal force and maintain this maximal pressure for 5 seconds. The MVIC is measured three times, separated by a 30-second pause, and the highest of the three MVIC values is registered
Time Frame
Baseline and 2 hours after the placement of the PPB
Title
Opioid consumption from 0-4 hours
Description
Registered from the electronic patient record
Time Frame
Subjects receiving PPB: From after PPB placement and up until 4 hours after PPB. Subjects not receiving PPB: From the end of the primary observation period (POP) and up until 4 hours after the end of the POP
Title
Opioid consumption from 4-24 hours
Description
Registered from the electronic patient record
Time Frame
Subjects receiving PPB: From 4 hours after PPB placement and up until 24 hours after PPB. Subjects not receiving PPB: From 4 hours after the end of the POP and up until 24 hours after the end of the POP
Title
Pain scores (Numerical Rating Scale, NRS, 0-10 where 0 is "no pain" and 10 is "worst pain imaginable"
Description
The patient is asked about the worst pain since last test time
Time Frame
For subjects receiving a PPB, pain scores will be performed 2, 4 and 24 hours after PPB. For subjects not receiving a PPB, final pain scores will be made at the 24 hrs follow-up visit
Title
Pain localization
Description
Evaluated using a systematic questionnaire
Time Frame
Subjects with NRS > 3: when significant pain is reported during the POP; 15 and 60 min after PPB; at any increase in NRS score at any time during the 60 min after PPB; 2, 4 and 24 hrs after PPB. For subjects with NRS ≤ 3: at the 24 hrs follow-up visit
Title
The number of patients requiring a PPB
Description
The number of patients experiencing NRS > 3 as a proportion of all patients with femoral triangle block (FTB)
Time Frame
All patients receive an FTB and are observed postoperatively for the development of NRS > 3 during the primary observation period (POP) defined as: A 3-hour observation period starting at the return of normal cutaneous sensation after spinal anesthesia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female at least 50 years of age at screening
Scheduled to undergo primary total knee arthroplasty in spinal anesthesia
Normal sensory function at the lateral part of the thigh and lower leg
American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
Able to provide informed consent
Exclusion Criteria:
Unable to cooperate and follow the study protocol
Communication problems
Allergic towards any medical product administered in the study
Diabetes requiring medical treatment
Pregnancy (a pregnancy test will be conducted on all women of childbearing potential prior to inclusion in the study. A positive test result will result in exclusion from the study)
Preoperative opioid treatment (dosed > once daily)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte R Sørensen, MD
Organizational Affiliation
Silkeborg Regional Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Silkeborg Regional Hospital
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27685346
Citation
Bendtsen TF, Moriggl B, Chan V, Borglum J. The Optimal Analgesic Block for Total Knee Arthroplasty. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):711-719. doi: 10.1097/AAP.0000000000000485.
Results Reference
background
PubMed Identifier
28002228
Citation
Wong WY, Bjorn S, Strid JM, Borglum J, Bendtsen TF. Defining the Location of the Adductor Canal Using Ultrasound. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):241-245. doi: 10.1097/AAP.0000000000000539.
Results Reference
background
PubMed Identifier
18915634
Citation
GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available.
Results Reference
background
PubMed Identifier
25099748
Citation
Abdallah FW, Chan VW, Gandhi R, Koshkin A, Abbas S, Brull R. The analgesic effects of proximal, distal, or no sciatic nerve block on posterior knee pain after total knee arthroplasty: a double-blind placebo-controlled randomized trial. Anesthesiology. 2014 Dec;121(6):1302-10. doi: 10.1097/ALN.0000000000000406.
Results Reference
background
PubMed Identifier
26896282
Citation
Abdallah FW, Madjdpour C, Brull R. Is sciatic nerve block advantageous when combined with femoral nerve block for postoperative analgesia following total knee arthroplasty? a meta-analysis. Can J Anaesth. 2016 May;63(5):552-68. doi: 10.1007/s12630-016-0613-2. Epub 2016 Feb 19.
Results Reference
background
PubMed Identifier
27171822
Citation
Runge C, Borglum J, Jensen JM, Kobborg T, Pedersen A, Sandberg J, Mikkelsen LR, Vase M, Bendtsen TF. The Analgesic Effect of Obturator Nerve Block Added to a Femoral Triangle Block After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):445-51. doi: 10.1097/AAP.0000000000000406.
Results Reference
background
PubMed Identifier
11903080
Citation
McNamee DA, Parks L, Milligan KR. Post-operative analgesia following total knee replacement: an evaluation of the addition of an obturator nerve block to combined femoral and sciatic nerve block. Acta Anaesthesiol Scand. 2002 Jan;46(1):95-9. doi: 10.1034/j.1399-6576.2002.460117.x.
Results Reference
background
PubMed Identifier
22025494
Citation
Taha AM. Brief reports: ultrasound-guided obturator nerve block: a proximal interfascial technique. Anesth Analg. 2012 Jan;114(1):236-9. doi: 10.1213/ANE.0b013e318237fb40. Epub 2011 Oct 24.
Results Reference
background
PubMed Identifier
27442773
Citation
Goffin P, Lecoq JP, Ninane V, Brichant JF, Sala-Blanch X, Gautier PE, Bonnet P, Carlier A, Hadzic A. Interfascial Spread of Injectate After Adductor Canal Injection in Fresh Human Cadavers. Anesth Analg. 2016 Aug;123(2):501-3. doi: 10.1213/ANE.0000000000001441.
Results Reference
background
PubMed Identifier
18929686
Citation
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Results Reference
background
PubMed Identifier
28937534
Citation
Runge C, Moriggl B, Borglum J, Bendtsen TF. The Spread of Ultrasound-Guided Injectate From the Adductor Canal to the Genicular Branch of the Posterior Obturator Nerve and the Popliteal Plexus: A Cadaveric Study. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):725-730. doi: 10.1097/AAP.0000000000000675.
Results Reference
background
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT03198403?term=NCT03198403&rank=1
Description
The pilot study on which the current study is based
Learn more about this trial
Popliteal Plexus Block for Total Knee Arthroplasty
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