Postoperative Pain Management After Total Knee Arthroplasty

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Knee Arthroplasty
• Intervention / Treatment: Procedure: Epidural analgesia - Group E; Procedure: Femoral blockade - Group F; Procedure: Intraarticular infusion - Group I

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Achaia
    • Pátra, Achaia, Greece, 26500
      • University Hospital of Patras

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group E- Epidural analgesia; Continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg for postoperative pain management right after the end of the procedure. The PCA pump is programmed with continuous infusion (Ropivacaine 0.2% + clonidine 150μg) 2ml/h and bolus dosage 0,5ml per 15min (max dosage 2ml/h). The epidural catheter is placed preoperatively.	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)
ACTIVE_COMPARATOR: Group F- Femoral blockade; Continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg for postoperative pain management right after the end of the procedure.The PCA pump is programmed with continuous infusion (Ropivacaine 0.2% + clonidine 150μg) 2ml/h and bolus dosage 0,5ml per 15min (max dosage 2ml/h). The femoral catheter is placed preoperatively.	Procedure: 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) .
ACTIVE_COMPARATOR: Group I- Intraarticular infusion; Continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg for postoperative pain management right after the end of the procedure.The PCA pump is programmed with continuous infusion (Ropivacaine 0.2% + clonidine 150μg) 2ml/h and bolus dosage 0,5ml per 15min (max dosage 2ml/h). The intraarticular catheter is placed before the closure of the incision.	Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobilization	Time of mobilization (standing, walking in room, walking out of room)	Up to 3 days
LOS	Length of hospital stay	Up to 3 months

Collaborators and Investigators

• Sponsor: University Hospital of Patras
• Investigators: Study Chair: Fotini Fligou, MD, PhD, University of Patras, Department of Anesthesiology and Critical Care Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2015
• Primary Completion (ACTUAL): October 30, 2019
• Study Completion (ACTUAL): October 30, 2019

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (ACTUAL): April 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: total knee arthroplasty; epidural analgesia; femoral nerve block; intra-articular infusion analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 10037/23.5.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO