Postoperative Pain Management After Total Knee Arthroplasty

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04344990
• Other study ID #: 10037/23.5.2016
• Status: Completed
• Phase: N/A
• Start date: June 29, 2015
• Est. completion date: October 30, 2019

Study information

• Verified date: April 2020
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patients scheduled for unilateral total knee arthroplasty (TKA) to treat knee osteoarthritis (OA)

2. Fully conversant in the Greek language

3. Written informed consent to participate in the trial

Exclusion Criteria:

1. Age less than 50 years and greater than 85 years.

2. ASA score >III

3. Pregnancy

4. Subarachnoid anesthesia failure

5. Hypersensitivity/ allergy to certain agent used

6. Participation in other research/ study

7. Severe mental disease (schizophrenia, major depression, severe bipolar disorder, substance abuse)

Related Conditions & MeSH terms

• Knee Arthroplasty
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Epidural analgesia - Group E
Postoperative 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)
• Femoral blockade - Group F
Postoperative 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) .
• Intraarticular infusion - Group I
Postoperative analgesia with continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150µg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min)

Locations

Country	Name	City	State
Greece	University Hospital of Patras	Pátra	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative analgesia	Pain scores, during rest and movement (active and passive) according to NRS (Numeric Rating Scale) right after the end of the surgery and 2, 4, 6, 12, 24, 36, 48, 60 and 72 hours later (postoperatively)	Up to 3 days
Secondary	Mobilization	Time of mobilization (standing, walking in room, walking out of room)	Up to 3 days
Secondary	LOS	Length of hospital stay	Up to 3 months