The effect of a new technique for anesthetizing the nerves involved in pain after knee replacement

The effect of the popliteal plexus block on postoperative pain after total knee arthroplasty - a randomized, controlled, double-blinded study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-005180-40-DK

Enrollment

Registered

2018-01-08

Start date

2018-02-19

Completion date

Unknown

Last updated

2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative posterior pain after total knee arthroplasty MedDRA version: 20.0 Level: PT Classification code 10023469 Term: Knee arthroplasty System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10002325 Term: Anesthesia local System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 10042613 - Surgical and medical

Interventions

Trade Name: Marcain-adrenaline Product Name: Marcain-adrenaline 5 mg/ml + 5 mikrogram/ml Pharmaceutical Form: Solution for injection Other descriptive name: BUPIVACAINE HYDROCHLORIDE Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female at least 50 years of age at screening - Scheduled to undergo primary total knee arthroplasty in spinal anaesthesia - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: 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) ;Secondary Objective: To evaluate the effect of the popliteal plexus block (PPB) in relation to opioid consumption, effect on sensory function and motor strength and to assess the onset time of the PPB. Furthermore, we aim to assess the number of patients who require a PBB as a supplement to a FTB.;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: After placement of the PPB, pain scores (NRS) are registered every 5 minutes until 15 minutes after PPB placement. Pain scores are registered again 30 min, 45 min and 60 min after PPB.	—

Measure

Time frame

Main Objective: 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) ;Secondary Objective: To evaluate the effect of the popliteal plexus block (PPB) in relation to opioid consumption, effect on sensory function and motor strength and to assess the onset time of the PPB. Furthermore, we aim to assess the number of patients who require a PBB as a supplement to a FTB.;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: After placement of the PPB, pain scores (NRS) are registered every 5 minutes until 15 minutes after PPB placement. Pain scores are registered again 30 min, 45 min and 60 min after PPB.

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Secondary

Measure	Time frame
Secondary end point(s): 1) Onset time of the PPB (defined as the time from withdrawal of the block needle and until the patient reports NRS = 3. Maximal onset time is defined as 60 min) 2) The effect of the PPB on cutaneous sensation on the lateral aspect of the lower leg (pinprick test) 3) The effect of PPB on isometric muscle strength of the dorso- and plantar flexors of the ankle joint (handheld dynamometer test) 4) Cumulated opioid consumption from 0-4 hours 5) Cumulated opioid consumption from 4-24 hours 6) Pain scores 7) Pain localization 8) The number of patients experiencing significant pain (NRS > 3) as a proportion of all patients with FTB ;Timepoint(s) of evaluation of this end point: 1) Pain scores every 5 min until 15 min after PPB and then every 15 min until 60 min after PPB 2) Baseline and 2 hrs after PPB 3) Baseline and 2 hrs after PPB 4) 0-4 hrs, registered from the electronic patient record (EPJ) 5) 4-24 hrs, registered from the EPJ 6) For subjects receiving a PPB: 2, 4 and 24 hrs after PPB. For subjects not receiving a PPB: 24 hrs after the end of the primary observation period (POP) 7) NRS > 3: when significant pain is reported during 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. NRS = 3: at the follow-up visit 24 hrs after the end of the POP 8) POP: 3-hour period starting at the return of completely normal cutaneous sensation after spinal anesthesia.	—

Measure

Time frame

Secondary end point(s): 1) Onset time of the PPB (defined as the time from withdrawal of the block needle and until the patient reports NRS = 3. Maximal onset time is defined as 60 min) 2) The effect of the PPB on cutaneous sensation on the lateral aspect of the lower leg (pinprick test) 3) The effect of PPB on isometric muscle strength of the dorso- and plantar flexors of the ankle joint (handheld dynamometer test) 4) Cumulated opioid consumption from 0-4 hours 5) Cumulated opioid consumption from 4-24 hours 6) Pain scores 7) Pain localization 8) The number of patients experiencing significant pain (NRS > 3) as a proportion of all patients with FTB ;Timepoint(s) of evaluation of this end point: 1) Pain scores every 5 min until 15 min after PPB and then every 15 min until 60 min after PPB 2) Baseline and 2 hrs after PPB 3) Baseline and 2 hrs after PPB 4) 0-4 hrs, registered from the electronic patient record (EPJ) 5) 4-24 hrs, registered from the EPJ 6) For subjects receiving a PPB: 2, 4 and 24 hrs after PPB. For subjects not receiving a PPB: 24 hrs after the end of the primary observation period (POP) 7) NRS > 3: when significant pain is reported during 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. NRS = 3: at the follow-up visit 24 hrs after the end of the POP 8) POP: 3-hour period starting at the return of completely normal cutaneous sensation after spinal anesthesia.

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Countries

Denmark

Contacts

Public ContactOperation og Intensiv Nord

Aarhus University Hospital

tfb@dadlnet.dk+4551542997

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026