Popliteal Plexus Block for Total Knee Arthroplasty

NCT03439787 | Terminated Phase 4 DMC

• 2 other identifiers: Protocol_PPB_TKA_311220172017-005180-40
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative

Keywords

Arthroplasty, Replacement, Knee; Anesthetics, Local; Pain, Postoperative; Nerve Block; Bupivacaine; Epinephrine

Outcome Measures

Primary Outcomes (1)

• 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

  60 minutes after placement of the PPB

Secondary Outcomes (8)

• Onset time of the PPB

  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

• The effect of the PPB on cutaneous sensation

  Baseline and 2 hours after the placement of the PPB

• The effect of PPB on isometric muscle strength of the he dorso- and plantar flexors of the ankle joint

  Baseline and 2 hours after the placement of the PPB

• Opioid consumption from 0-4 hours

  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

• Opioid consumption from 4-24 hours

  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

Study Arms (2)

Active Popliteal Plexus Block

ACTIVE COMPARATOR

10 ml Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution

Drug: Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution

Placebo Popliteal Plexus Block

PLACEBO COMPARATOR

10 ml Sodium Chloride 0.9 %

Other: Sodium Chloride 0.9 %

Interventions

Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution DRUG

10 ml

Also known as: Marcain-adrenaline

Active Popliteal Plexus Block

Sodium Chloride 0.9 % OTHER

10 ml

Placebo Popliteal Plexus Block

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to cooperate and follow the study protocol
• Communication problems
• Allergic towards any medical product administered in the study
• Diabetes requiring medical treatment
• Preoperative opioid treatment (dosed \> once daily)

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

Related Publications (11)

• 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.

  PMID: 27685346 BACKGROUND

• 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.

  PMID: 28002228 BACKGROUND

• GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available.

  PMID: 18915634 BACKGROUND

• 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.

  PMID: 25099748 BACKGROUND

• 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.

  PMID: 26896282 BACKGROUND

• 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.

  PMID: 27171822 BACKGROUND

• 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.

  PMID: 11903080 BACKGROUND

• 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.

  PMID: 22025494 BACKGROUND

• 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.

  PMID: 27442773 BACKGROUND

• 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.

  PMID: 18929686 BACKGROUND

• 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.

  PMID: 28937534 BACKGROUND

Related Links

• The pilot study on which the current study is based

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Charlotte R Sørensen, MD

  Silkeborg Regional Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blinded design

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 20, 2018
• Study Start: May 15, 2018
• Primary Completion: August 23, 2018
• Study Completion: August 23, 2018
• Last Updated: April 25, 2019

Record last verified: 2018-08

Locations

DK (1)