The effect of a new peripheral nerve block, popliteal plexus block, on postoperative opioid use, postoperative pain, muscle strength of the leg and mobilization after total knee replacement surgery - a randomized, controlled, blinded study

The effect of the popliteal plexus block on postoperative opioid consumption, pain, muscle strength and mobilization after total knee arthroplasty - a randomized, controlled, blinded study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000242-17-DK

Enrollment

165

Registered

2021-01-27

Start date

2021-03-12

Completion date

Unknown

Last updated

2023-07-18

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

Conditions

Postoperative pain following a total knee arthroplasty surgery MedDRA version: 21.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865

Interventions

Trade Name: Marcaine Pharmaceutical Form: Solution for injection INN or Proposed INN: BUPIVACAINE CAS Number: 2180-92-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Scheduled to undergo primary total knee arthroplasty in spinal anesthesia Able to perform a Timed Up and Go (TUG) test Age > 50 years old Ability to give their written informed consent to participating in the study after having fully understood the contents of the study American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: Patients who cannot cooperate Patients who cannot understand or speak Danish. Patients with allergy or intolerance to the medicines used in the study Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) Patients suffering from alcohol and/or drug abuse – based on the investigator's assessment Diagnosed with chronic central or peripheral neurodegenerative disorders Body Mass Index > 40

Design outcomes

Primary

Measure	Time frame
Main Objective: We aim to evaluate the analgesic effects of three different nerve block regimens (Popliteal Plexus Block + Femoral Triangle Block versus Femoral Triangle Block versus Adductor Canal Block) after primary unilateral total knee arthroplasty (TKA), in order to optimize pain treatment for TKA patients and minimize the use of opioids. We observe TKA patients opioid consumption and pain scores in the period of 24 hours postoperative, while testing their muscle strength and ability to mobilize. ;Secondary Objective: not applicable;Primary end point(s): Total opioid consumption in each group, A, B and C (PCA pump and any potential rescue administration, calculated as IV morphine equivalents);Timepoint(s) of evaluation of this end point: At 24 hours after surgery, defined as 24 hours after time of final suture	—

Measure

Time frame

Main Objective: We aim to evaluate the analgesic effects of three different nerve block regimens (Popliteal Plexus Block + Femoral Triangle Block versus Femoral Triangle Block versus Adductor Canal Block) after primary unilateral total knee arthroplasty (TKA), in order to optimize pain treatment for TKA patients and minimize the use of opioids. We observe TKA patients opioid consumption and pain scores in the period of 24 hours postoperative, while testing their muscle strength and ability to mobilize. ;Secondary Objective: not applicable;Primary end point(s): Total opioid consumption in each group, A, B and C (PCA pump and any potential rescue administration, calculated as IV morphine equivalents);Timepoint(s) of evaluation of this end point: At 24 hours after surgery, defined as 24 hours after time of final suture

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Secondary

Measure	Time frame
Secondary end point(s): Total opioid consumption in each group, A, B and C (PCA pump and any potential rescue administration, calculated as IV morphine equivalents) Post-block Maximum Voluntary Isometric Contraction (MVIC) by knee extension, calculated as a percentage of the Pre-block baseline value Post-block MVIC by ankle plantarflexion, calculated as a percentage of the Pre-block baseline value Post-block MVIC by ankle dorsiflexion, calculated as a percentage of the Pre-block baseline value Muscle strength of knee extension, graded by Manual Muscle Test (MMT) Muscle strength of ankle plantarflexion, graded by MMT Muscle strength of ankle dorsiflexion, graded by MMT Time (seconds) to perform Times Up and Go (TUG) test Worst pain during TUG gradet by Numeric Rating Scale (NRS) Postoperative pain intensity (NRS) at rest analyzed using a linear mixed model with the inclusion of all time points Postoperative pain scores (NRS) at 90 degrees active flexion of the knee analyzed using a linear mixed model with the inclusion of all time points. ;Timepoint(s) of evaluation of this end point: Total opioid consumption is 12 hours after time of final suture MVICs are testet prior to nerve block procedure (preoperative) and 60 minutes after nerve block procedure (preoperative) Muscle strength tests by MMT are performed prior to nerve block (preoperative) and 60 minutes after nerve block procedure (peroperative) and postoperative 5 hours after time of final suture TUG test and worst pain during TUG is performed 5 hours after time of final suture Postoperative pain at rest and during 90 degrees of knee flexion is obtained preoperativ, before peripheral nerve block procedure, and at 2, 5, 7, 20 and 24 hours after time of final suture	—

Measure

Time frame

Secondary end point(s): Total opioid consumption in each group, A, B and C (PCA pump and any potential rescue administration, calculated as IV morphine equivalents) Post-block Maximum Voluntary Isometric Contraction (MVIC) by knee extension, calculated as a percentage of the Pre-block baseline value Post-block MVIC by ankle plantarflexion, calculated as a percentage of the Pre-block baseline value Post-block MVIC by ankle dorsiflexion, calculated as a percentage of the Pre-block baseline value Muscle strength of knee extension, graded by Manual Muscle Test (MMT) Muscle strength of ankle plantarflexion, graded by MMT Muscle strength of ankle dorsiflexion, graded by MMT Time (seconds) to perform Times Up and Go (TUG) test Worst pain during TUG gradet by Numeric Rating Scale (NRS) Postoperative pain intensity (NRS) at rest analyzed using a linear mixed model with the inclusion of all time points Postoperative pain scores (NRS) at 90 degrees active flexion of the knee analyzed using a linear mixed model with the inclusion of all time points. ;Timepoint(s) of evaluation of this end point: Total opioid consumption is 12 hours after time of final suture MVICs are testet prior to nerve block procedure (preoperative) and 60 minutes after nerve block procedure (preoperative) Muscle strength tests by MMT are performed prior to nerve block (preoperative) and 60 minutes after nerve block procedure (peroperative) and postoperative 5 hours after time of final suture TUG test and worst pain during TUG is performed 5 hours after time of final suture Postoperative pain at rest and during 90 degrees of knee flexion is obtained preoperativ, before peripheral nerve block procedure, and at 2, 5, 7, 20 and 24 hours after time of final suture

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Countries

Denmark

Contacts

Public ContactJohan Kløvgaard Sørensen

Region Hospital Silkeborg

joksoe@rm.dk004528945356

Outcome results

None listed

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