Postoperative PainNCT04344990
Postoperative Pain Management After Total Knee Arthroplasty
A study testing Epidural analgesia - Group E, Femoral blockade - Group F and Intraarticular infusion - Group I in people with Postoperative Pain and Knee Arthroplasty, run by University Hospital of Patras at 1 site in Greece.
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 Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Postoperative Pain, Knee Arthroplasty
- What is being tested?
- Epidural analgesia - Group E, Femoral blockade - Group F and Intraarticular infusion - Group I
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGreece
- Study dates
- 29 Jun 2015to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Postoperative Pain, Knee Arthroplasty
- Being tested
- Epidural analgesia - Group E, Femoral blockade - Group F, Intraarticular infusion - Group I
- Keywords
- epidural analgesia, intra-articular infusion analgesia;, femoral nerve block, total knee arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesia - Group EProcedure or surgery
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 FProcedure or surgery
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 IProcedure or surgery
Postoperative analgesia with continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min)
| Study group | Role | What they receive |
|---|---|---|
| Group E- Epidural analgesia | Active comparator | 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. Receives: Procedure: Epidural analgesia - Group E |
| Group F- Femoral blockade | Active comparator | 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. Receives: Procedure: Femoral blockade - Group F |
| Group I- Intraarticular infusion | Active comparator | 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. Receives: Procedure: Intraarticular infusion - Group I |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 3 days
Secondary outcomes (2)
Mobilization
Time of mobilization (standing, walking in room, walking out of room)
Measured: Up to 3 days
LOS
Length of hospital stay
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start29 Jun 2015
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Karpetas, University Hospital of Patras
- Investigators
- Fotini Fligou, MD, PhD, Study chair, University of Patras, Department of Anesthesiology and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344990
- Sponsor's protocol ID
- 10037/23.5.2016
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2017
- Last updated
- 14 Apr 2020
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of Three Different Methods of Postoperative Pain Management After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04344990
- Acronym / sponsor ID
- 10037/23.5.2016
- Conditions
- Postoperative Pain, Knee Arthroplasty
- Keywords
- epidural analgesia, intra-articular infusion analgesia;, femoral nerve block, total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 29 Jun 2015 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group E- Epidural analgesia | Active comparator | Procedure: Epidural analgesia - Group EContinuous 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. |
| Group F- Femoral blockade | Active comparator | Procedure: Femoral blockade - Group FContinuous 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. |
| Group I- Intraarticular infusion | Active comparator | Procedure: Intraarticular infusion - Group IContinuous 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Age less than 50 years and greater than 85 years.
- ASA score >III
- Pregnancy
- Subarachnoid anesthesia failure
- Hypersensitivity/ allergy to certain agent used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural 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) | Procedure or surgery | Group E- Epidural analgesia |
| Femoral 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) . | Procedure or surgery | Group F- Femoral blockade |
| Intraarticular 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) | Procedure or surgery | Group I- Intraarticular infusion |
Primary outcome
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)
2 secondary outcomes
Mobilization
Time frame: Up to 3 days
LOS
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fotini Fligou, MD, PhD study chair
University of Patras, Department of Anesthesiology and Critical Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural analgesia - Group E, Femoral blockade - Group F and Intraarticular infusion - Group I in people with Postoperative Pain and Knee Arthroplasty, run by University Hospital of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesia (time frame: Up to 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.