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Completed

NCT Number: NCT04344990

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

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Patras

Pátrai, Achaia, 26500, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Epidural analgesia - Group E

Procedure

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

Procedure

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

Procedure

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 outcomes

  1. Postoperative analgesia

    Time frame: Up to 3 days

    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 outcomes

  1. Mobilization

    Time frame: Up to 3 days

    Time of mobilization (standing, walking in room, walking out of room)

  2. LOS

    Time frame: Up to 3 months

    Length of hospital stay

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2020
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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