Clinical Trials Directory

Trials / Completed

CompletedNCT04344990

Postoperative Pain Management After Total Knee Arthroplasty

Comparison Study of Three Different Methods of Postoperative Pain Management After Total Knee Arthroplasty

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
72 (actual)
Sponsor
University Hospital of Patras · Academic / Other
Sex
All
Age
50 Years – 85 Years
Healthy volunteers
Not accepted

Summary

The study compares three different analgesic techniques in order to determine which one serves as the optimal method for postoperative pain management after Total Knee Arthroplasty in patients suffering from Osteoarthritis

Detailed description

Prospective, randomized, controlled study. Approval of the study from the University Hospital of Patras Ethics Committee. The Total Knee Arthroplasty procedure is performed always from the same team of Orthopedic surgeons who follow the same technique in each patient for the arthroplasty and the placement of the intraarticular catheter as well. The same team of Anesthesiologists (two Anesthesiologists) performs always the same technique for each analgesic method and is responsible for the patients' perioperative condition concerning anesthesia and analgesia. Preoperatively, one hour prior to the surgery, all patients receive preemptive multimodal analgesia in the following way; 40mg Parecoxib (iv), 1gr Paracetamol (iv), 150mg Pregabalin (po), 8mg Dexamethasone (iv) και 50mg Ranitidine (iv). All patients receive subarachnoid anesthesia with Ropivacaine 0.75% (7,5mg/ml) in a dosage of 2-3ml titrated according to patient's age and height. Three groups 1. Continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg. 2. Continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg. 3. Continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg. All the catheters remain for 48 hours while the infusion rate is 2ml/h + PCA with 0,5ml/15min and lock-out maximum dose 4/h in total volume of 150ml. Postoperatively all patients also receive; Parecoxib, Paracetamol, Pregabalin, and Ranitidine up to the third postoperative day (doses titrated). Rescue analgesia: Tramadol Chloride 50-100mg x 2 /24h depending on patient's age and medical history.

Conditions

Interventions

TypeNameDescription
PROCEDUREEpidural analgesia - Group EPostoperative analgesia with continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min)
PROCEDUREFemoral blockade - Group FPostoperative analgesia with continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min) .
PROCEDUREIntraarticular infusion - Group IPostoperative analgesia with continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min)

Timeline

Start date
2015-06-29
Primary completion
2019-10-30
Completion
2019-10-30
First posted
2020-04-14
Last updated
2020-04-14

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT04344990. Inclusion in this directory is not an endorsement.