A study investigating the effect on pain and morphine consumption of different pumpsettings for providing local anesthetics for a nerve block.

Adductor canal block with continuous infusion versus intermittent boluses and morphine consumption: A randomized, triple-masked, controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005642-22-DK

Enrollment

Unknown

Registered

2015-01-09

Start date

2015-03-06

Completion date

Unknown

Last updated

2016-09-26

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

Conditions

Primary total knee arthroplasty MedDRA version: 17.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: Ropivacaine 2 mg/ml Product Name: Ropivacaine Pharmaceutical Form: Solution for injection INN or Proposed INN: ROPIVACAINE CAS Number: 84057-95-4 Concentration unit: mg/ml milligram(s)/mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age > 18 years old • Patients scheduled for total knee arthroplasty in spinal anesthesia • ASA 1-3 • Ability to perform a TUG test preoperatively 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 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55

Exclusion criteria

Exclusion criteria: • Patients with allergy to the medicines used in the study • Daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks • Rheumatoid arthritis • BMI > 40 • Neuromuscular pathology in the lower limbs

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to compare the analgesic effect of administering ropivacaine for an adductor canal block as re-peated intermittent boluses compared with a continuous infusion. ;Secondary Objective: Not applicable;Primary end point(s): Difference in total opioid consumption (PCA pump and any potential rescue or non-protocolled administration) between groups, from end of surgery until 12 PM on POD 2 .;Timepoint(s) of evaluation of this end point: Cummulative opioid consumption from end of surgery until 12 PM on POD 2, assessed at the PACU, at 8 PM on the day of surgery, at 8 AM, 12 Pm and 8 AM on POD 1 and finally at 8 AM and 12 PM on POD 2.	—

Measure

Time frame

Main Objective: The aim of the study is to compare the analgesic effect of administering ropivacaine for an adductor canal block as re-peated intermittent boluses compared with a continuous infusion. ;Secondary Objective: Not applicable;Primary end point(s): Difference in total opioid consumption (PCA pump and any potential rescue or non-protocolled administration) between groups, from end of surgery until 12 PM on POD 2 .;Timepoint(s) of evaluation of this end point: Cummulative opioid consumption from end of surgery until 12 PM on POD 2, assessed at the PACU, at 8 PM on the day of surgery, at 8 AM, 12 Pm and 8 AM on POD 1 and finally at 8 AM and 12 PM on POD 2.

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Secondary

Measure	Time frame
Secondary end point(s): • VAS pain scores (0–100 mm) during 45 degrees active knee flexion analyzed using a line-ar mixed model • VAS pain scores (0–100 mm) at rest analyzed using a linear mixed model • Worst pain (VAS, 0–100 mm) during the TUG test • Quadriceps strength assessed as MVIC in percentage of preoperative baseline values • Time (seconds) to perform the Timed up and Go (TUG) test • Number of patients able to perform the TUG test, using crutches • 6 min walk test performed using crutches ;Timepoint(s) of evaluation of this end point: VAS pain scores at rest and during knee flexion will be assessed at the PACU, at 8 PM on the day of surgery, at 8 AM, 12 Pm and 8 AM on POD 1 and finally at 8 AM and 12 PM on POD 2. Worst pain during the TUG test, the TUG test, quadriceps strength and the 6 min walk test will be assesseed at 12 PM on POD 1 and 2.	—

Measure

Time frame

Secondary end point(s): • VAS pain scores (0–100 mm) during 45 degrees active knee flexion analyzed using a line-ar mixed model • VAS pain scores (0–100 mm) at rest analyzed using a linear mixed model • Worst pain (VAS, 0–100 mm) during the TUG test • Quadriceps strength assessed as MVIC in percentage of preoperative baseline values • Time (seconds) to perform the Timed up and Go (TUG) test • Number of patients able to perform the TUG test, using crutches • 6 min walk test performed using crutches ;Timepoint(s) of evaluation of this end point: VAS pain scores at rest and during knee flexion will be assessed at the PACU, at 8 PM on the day of surgery, at 8 AM, 12 Pm and 8 AM on POD 1 and finally at 8 AM and 12 PM on POD 2. Worst pain during the TUG test, the TUG test, quadriceps strength and the 6 min walk test will be assesseed at 12 PM on POD 1 and 2.

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Countries

Denmark

Contacts

Public ContactClinical Trials Information

Rigshospitalet

pia.therese.jaeger@regionh.dk004535453478

Outcome results

None listed

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