Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01631799
Other study ID # A 40 2008
Secondary ID
Status Completed
Phase N/A
First received June 27, 2012
Last updated June 27, 2012
Start date October 2008
Est. completion date December 2011

Study information

Verified date June 2012
Source University of Rostock
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

Total knee replacement is very common in Germany. After surgery patients have severe pain in the knee; initiation of the physiotherapy, however, is important in the first three days after surgery. Continuous femoral blockade and continuous (lumbar) epidural analgesia are commonly used after surgery. Both methods are used in Germany. Both methods have advantages and disadvantages. We wanted to answer the question which method of analgesia - after total knee replacement - is better concerning complications and function (after 3 months) ?


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- age 18 -80 years

- ASA I-III

- Surgery: total knee replacement

- informed consent

Exclusion Criteria:

- obesity

- contraindication for epidural anesthesia

- coagulation disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Femoral catheter
Femoral catheter was inserted at the beginning of surgery. After surgery ropivacaine was administered continuously for three days. In addition, patients received piritramide via patient-controlled analgesia. The amount of ropivacaine was measured.
Epidural catheter
The epidural catheter was inserted at the beiginning of surgery. After surgery ropivacaine was applied continuously for three days. In addition, patients received piritramide via patient controlled analgesia. The amount of ropivacaine was measured.

Locations

Country Name City State
Germany University of Rostock Rostock Mecklenburg/Vorpommern

Sponsors (1)

Lead Sponsor Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Function 3 months after surgery the function of the total knee replacement is testd 3 months after surgery No
Secondary Mortality 28 days after surgery No
Secondary Morbidity 28 days after surgery No
See also
  Status Clinical Trial Phase
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04092465 - Outcomes of Surgical Resection After Induction Treatment in Non-Small Cell Lung Cancer (SRaIT)
Completed NCT03296423 - Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly Phase 4
Not yet recruiting NCT04900610 - The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis N/A
Completed NCT04149873 - Effectness of Treatment With Mechanical Insufflation-Exsufflation N/A
Completed NCT05905042 - Follow-up of Recovery Condition in Survivors of Acute Respiratory Distress Syndrome
Completed NCT00527774 - Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients N/A
Completed NCT00518856 - Lufwanyama Neonatal Survival Project N/A
Completed NCT06408636 - Prognostic Role of LA Strain in Acute Myocardial Infarction
Completed NCT06051526 - The African Critical Illness Outcomes Study
Recruiting NCT05055089 - Short- and Medium-term Results of New Generation Aortic
Active, not recruiting NCT04132492 - AGNES - Aging Nephropathy Study, a Prospective Observational Cohort of Chronic Kidney Disease in Elderly Patients
Completed NCT03885206 - Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital N/A
Completed NCT05573659 - Capillary Refill Time Calculated With a Video-assisted Method Has a Better Reproducibility Than Visual Method in Critically Ill Patients N/A
Withdrawn NCT03245658 - The Effect of Cannabis in Pancreatic Cancer Phase 2
Recruiting NCT04094428 - Burden, Mortality and Supply Costs in Intensive Care Unit Patients
Completed NCT00244673 - Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination Phase 4
Completed NCT03378843 - Spermidine Intake and All-cause Mortality N/A
Recruiting NCT04424511 - Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Mali Phase 3
Completed NCT04032288 - Establish a Prospective Registration System of ARDS Patients for Improving Quality of Care