The effect of saphenous nerve and obturator nerve block combined with intravenous given glucocorticoid compared with infiltration of local anesthetic in the tissue around the knee joint combined with intravenous given glucocorticoid, on opioid consumption and pain after total knee arthroplasty.

The effect of saphenous nerve and obturator nerve block combined with systemic high dose glucocorticoid versus local infiltration analgesia combined with a systemic high dose glucocorticoid on opioid consumption and pain after total knee arthroplasty. - Prolonged combined block after total knee arthroplasty

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003343-35-DK

Enrollment

Unknown

Registered

2014-08-06

Start date

2014-10-01

Completion date

Unknown

Last updated

2016-09-05

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

Conditions

The medical condition to be examined in this study is the first postoperative period after total knee replacement with a view to pain management. MedDRA version: 17.1 Level: LLT Classification code 10038286 Term: Regional nerve block System Organ Class: 100000004865

Interventions

Trade Name: Dexamethason Krka Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: dexamethasone CAS Number: 312-93-6 Other descriptive name: DEXAMETHASONE PHOSPHATE Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age> 50 years • Patients set to cemented Total knee arthroplasty in spinal block • ASA 1-3 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64

Exclusion criteria

Exclusion criteria: • Patients who can not cooperate with the investigation • Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully • Patients who do not understand or speak Danish • Patients receiving immunosuppressive therapy •Patients receiving glucocorticoid daily • Patients with a treatment-dependent diabetes mellitus • Patients with known neuropathy in the lower limbs • Allergy to those used in the study drugs • Alcohol and / or drug abuse - the investigator's opinion • Patients who can not tolerate NSAIDs • Fixed several times daily consumption of strong opioids (morphine, ketogan, Oxynorm, methadone, fentanyl)

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim is to investigate the effect of combined saphenous nerve and obturator nerve block with a mixture of local analgesics; ropivacaine and adrenaline, compared with combined local infiltration analgesia in the tissue around the knee joint both methods combined with systemic high dose glucocorticoid on opioid consumption after total knee arthroplasty.;Secondary Objective: Secondarily it is to investigate the effect of combined saphenous nerve and obturator nerve blockade compared with local infiltration analgesia in the tissue around the knee joint both methods combined with a systemic high dose glucocorticoid on pain and block duration after total knee arthroplasty.;Primary end point(s): • Consumption of opioid from 0 to 20 hours postoperatively, via patient-controlled analgesia-(PCA) pump. The patient is instructed to self-administer a dose when NRS (numeric rating scale) > 3 at rest.;Timepoint(s) of evaluation of this end point: Time 20 hours postoperatively	—

Measure

Time frame

Main Objective: The aim is to investigate the effect of combined saphenous nerve and obturator nerve block with a mixture of local analgesics; ropivacaine and adrenaline, compared with combined local infiltration analgesia in the tissue around the knee joint both methods combined with systemic high dose glucocorticoid on opioid consumption after total knee arthroplasty.;Secondary Objective: Secondarily it is to investigate the effect of combined saphenous nerve and obturator nerve blockade compared with local infiltration analgesia in the tissue around the knee joint both methods combined with a systemic high dose glucocorticoid on pain and block duration after total knee arthroplasty.;Primary end point(s): • Consumption of opioid from 0 to 20 hours postoperatively, via patient-controlled analgesia-(PCA) pump. The patient is instructed to self-administer a dose when NRS (numeric rating scale) > 3 at rest.;Timepoint(s) of evaluation of this end point: Time 20 hours postoperatively

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Secondary

Measure	Time frame
Secondary end point(s): • The total consumption of opioid from time 0 to 24 hours postoperatively , at the PCA pump . • Pain Score with NRS - with values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, by passive flexion of the knee joint from 0-90 degrees time 2 , 6, 20 and 24 hours postoperatively . • Reported pain Score at rest at time 2, 6 , 20 and 24 hours postoperatively . Where highest score since last score recorded. • Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest) reported by the patient • Nausea Score with NRS (numeric rating scale ) - with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea time 2, 6, 20, 24 hours postoperatively . • Number of vomiting between 0- 20 hours and 0-24 hours postoperatively . • Consumption of Ondansetron between 0-20 hours and 0-24 hours postoperatively . •Reporting of dizziness at time 2, 6, 20 and 24 hours postoperatively. Recording whether the dizziness is preventing mobilization. • Duration of stay (length of stay , LOS ) in the observation unit (post anesthesia care unit , pacu). The end time for the LOS in PACU recorded at the time when the patient meets DASAIMs (Danish Society of Anaesthesiology and Intensive Therapy) printing criteria - regardless of Pacu 's logistics in general. • Discharge time from the hospital or maximum 60 hour postoperatively. • Mobilization and Function: • Preoperatively isometric tests of muscle strength in the hip adductors by a handheld dynamometer before and 30 minutes after performed nerve blockades. The patient performed 4-10 measurements with a 30 second break in between each measurement. The difference between the highest value for the test before and after nerve block is calculated. Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses. ;Timepoint(s) of evaluation of this end point: 1-2 hours preoperatively evaluation: - Pain score at re	—

Measure

Time frame

Secondary end point(s): • The total consumption of opioid from time 0 to 24 hours postoperatively , at the PCA pump . • Pain Score with NRS - with values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, by passive flexion of the knee joint from 0-90 degrees time 2 , 6, 20 and 24 hours postoperatively . • Reported pain Score at rest at time 2, 6 , 20 and 24 hours postoperatively . Where highest score since last score recorded. • Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest) reported by the patient • Nausea Score with NRS (numeric rating scale ) - with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea time 2, 6, 20, 24 hours postoperatively . • Number of vomiting between 0- 20 hours and 0-24 hours postoperatively . • Consumption of Ondansetron between 0-20 hours and 0-24 hours postoperatively . •Reporting of dizziness at time 2, 6, 20 and 24 hours postoperatively. Recording whether the dizziness is preventing mobilization. • Duration of stay (length of stay , LOS ) in the observation unit (post anesthesia care unit , pacu). The end time for the LOS in PACU recorded at the time when the patient meets DASAIMs (Danish Society of Anaesthesiology and Intensive Therapy) printing criteria - regardless of Pacu 's logistics in general. • Discharge time from the hospital or maximum 60 hour postoperatively. • Mobilization and Function: • Preoperatively isometric tests of muscle strength in the hip adductors by a handheld dynamometer before and 30 minutes after performed nerve blockades. The patient performed 4-10 measurements with a 30 second break in between each measurement. The difference between the highest value for the test before and after nerve block is calculated. Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses. ;Timepoint(s) of evaluation of this end point: 1-2 hours preoperatively evaluation: - Pain score at re

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Countries

Denmark

Contacts

Public ContactCentre of Elective Surgery

Hospital of Silkeborg

charlotte.runge@aarhus.rm.dk004525883172

Outcome results

None listed

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