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Postoperative Pain Management After Total Knee Arthroplasty

Primary Purpose

Postoperative Pain, Knee Arthroplasty

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Epidural analgesia - Group E
Femoral blockade - Group F
Intraarticular infusion - Group I
Sponsored by
University Hospital of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring epidural analgesia, intra-articular infusion analgesia;, femoral nerve block, total knee arthroplasty

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital of Patras

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group E- Epidural analgesia

Group F- Femoral blockade

Group I- Intraarticular infusion

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Mobilization
Time of mobilization (standing, walking in room, walking out of room)
LOS
Length of hospital stay

Full Information

First Posted
April 19, 2017
Last Updated
April 9, 2020
Sponsor
University Hospital of Patras
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1. Study Identification

Unique Protocol Identification Number
NCT04344990
Brief Title
Postoperative Pain Management After Total Knee Arthroplasty
Official Title
Comparison Study of Three Different Methods of Postoperative Pain Management After Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 29, 2015 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Patras

4. Oversight

5. Study Description

Brief 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 Continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg. Continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Knee Arthroplasty
Keywords
epidural analgesia, intra-articular infusion analgesia;, femoral nerve block, total knee arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group E- Epidural analgesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group F- Femoral blockade
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group I- Intraarticular infusion
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Epidural analgesia - Group E
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Femoral blockade - Group F
Intervention Description
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) .
Intervention Type
Procedure
Intervention Name(s)
Intraarticular infusion - Group I
Intervention Description
Postoperative analgesia with continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min)
Primary Outcome Measure Information:
Title
Postoperative analgesia
Description
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)
Time Frame
Up to 3 days
Secondary Outcome Measure Information:
Title
Mobilization
Description
Time of mobilization (standing, walking in room, walking out of room)
Time Frame
Up to 3 days
Title
LOS
Description
Length of hospital stay
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for unilateral total knee arthroplasty (TKA) to treat knee osteoarthritis (OA) Fully conversant in the Greek language Written informed consent to participate in the trial Exclusion Criteria: Age less than 50 years and greater than 85 years. ASA score >III Pregnancy Subarachnoid anesthesia failure Hypersensitivity/ allergy to certain agent used Participation in other research/ study Severe mental disease (schizophrenia, major depression, severe bipolar disorder, substance abuse)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fotini Fligou, MD, PhD
Organizational Affiliation
University of Patras, Department of Anesthesiology and Critical Care Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Patras
City
Pátra
State/Province
Achaia
ZIP/Postal Code
26500
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Postoperative Pain Management After Total Knee Arthroplasty

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