The effect of popliteal plexus block (PPB) on pain after total knee replacement(TKR)

The effect of popliteal plexus block on pain after total knee replacement - The effect of PPB after TKR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001644-35-DK

Enrollment

Registered

2017-04-20

Start date

2017-06-01

Completion date

Unknown

Last updated

2020-05-11

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

Conditions

In this study we investigate pain after total knee replacement MedDRA version: 20.0 Level: LLT Classification code 10038286 Term: Regional nerve block System Organ Class: 100000004865

Interventions

Trade Name: Marcain-adrenalin Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Bupivacaine Other descriptive name: BUPIVACAINE HYDROCHLORIDE Concentration unit: mg/ml m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age over 18 years ASA 1-3 Sceduled for TKR 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 2 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: • no cooperation • Pregnacy • Allergy for local anesthetic • preoperatively reduced sensory on the lower limb • Diabetic • Patients in use of opioids Not understanding or speaking Danish

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this trial is to evaluate the effect of popliteal plexus block (PPB) on pain after total knee replacement (TKR);Secondary Objective: To assess the onset time of a PPB block and to assess the sensory of the skin after the PPB is applicated;Primary end point(s): To assess the effect of PPB in the fraction of patients with postoperative pain NRS > 3 (numeric rating scale), and with decreasing NRS < 3 after PPB is applicated.;Timepoint(s) of evaluation of this end point: During the first postoperative 6 hours.	—

Measure

Time frame

Main Objective: The aim of this trial is to evaluate the effect of popliteal plexus block (PPB) on pain after total knee replacement (TKR);Secondary Objective: To assess the onset time of a PPB block and to assess the sensory of the skin after the PPB is applicated;Primary end point(s): To assess the effect of PPB in the fraction of patients with postoperative pain NRS > 3 (numeric rating scale), and with decreasing NRS < 3 after PPB is applicated.;Timepoint(s) of evaluation of this end point: During the first postoperative 6 hours.

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Secondary

Measure	Time frame
Secondary end point(s): • The fraction of patients with a femoral triangle block who get pain (NRS > 3) • Onset time of the PPB • Turn off time of the spinal anesthesia • Association of normal sensory after spinal anesthesia and developing of pain. • Assessment of sensory after PPB • Assessment of muscle strength in the ankle joint after PPB ;Timepoint(s) of evaluation of this end point: During the first 6 hours postoperatively	—

Measure

Time frame

Secondary end point(s): • The fraction of patients with a femoral triangle block who get pain (NRS > 3) • Onset time of the PPB • Turn off time of the spinal anesthesia • Association of normal sensory after spinal anesthesia and developing of pain. • Assessment of sensory after PPB • Assessment of muscle strength in the ankle joint after PPB ;Timepoint(s) of evaluation of this end point: During the first 6 hours postoperatively

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Countries

Denmark

Contacts

Public ContactCentre of Elective Surgery

Silkeborg Regional Hospital

charlotte.runge@aarhus.rm.dk004525883172

Outcome results

None listed

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