Postoperative PainNCT07175883
Comparison of Postoperative Pain in Primary Cemented Total Knee Arthroplasty With or Without Drain
A study testing Redon drain in people with Postoperative Pain and Arthropathy of Knee, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
Trial summary
The use of closed aspirative surgical drainage presents a truly questionable role in the field of orthopedic surgery. The pathophysiological mechanisms on which it acts have been widely theorized, as well as the disadvantages that could be associated, both at a biological and socio-sanitary level, so that clinical… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Pain, Arthropathy of Knee
- What is being tested?
- Redon drain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 12 Mar 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 60 years of age
- Candidates for hybrid total knee arthroplasty with preservation of the posterior cruciate ligament
Who cannot join
- Patients with previous ipsilateral or contralateral knee surgery (contralateral knee arthroplasty, osteotomized, previous cruciate ligament or meniscal repair included)
- History of rheumatologic diseases
- History of articular infection
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Unievrsitario Reina Sofia de Córdoba
Córdoba, CORDOBA, 14004
About this study
The use of closed aspirative surgical drainage presents a truly questionable role in the field of orthopedic surgery.
The pathophysiological mechanisms on which it acts have been widely theorized, as well as the disadvantages that could be associated, both at a biological and socio-sanitary level, so that clinical guidelines opt to leave the decision to the surgeon's discretion.
Read more
Although its application and postoperative complications in knee arthroplasty are widely documented, the results are inconclusive and the scientific community does not seem to reach a consensus.
The main debate centers on bleeding during the immediate postoperative period, a classic complication of these interventions, but which seems to be being avoided with the introduction of new techniques and drugs, mainly the use of tranexamic acid.
However, a fundamental element of the postoperative period of these interventions that all the research seems to omit is pain in the postoperative period, which is key, as the pain of gonarthrosis is the main indication for the intervention.
It is because of this lack in the essential knowledge of this intervention that we propose the following hypothesis: the use of drainage in knee arthroplasty does not reduce pain during the early postoperative period.
- Conditions
- Postoperative Pain, Arthropathy of Knee
- Being tested
- Redon drain
- Keywords
- drainage, Arthroplasty, Replacement, Knee, Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redon drainProcedure or surgery
Patients in group A will have a Redon drain placed at the end of the procedure following the usual technique
| Study group | Role | What they receive |
|---|---|---|
| DRAINAGE GROUP (A) | Experimental | Patients in group A will have a Redon drain placed at the end of the procedure. Both groups of patients will be explained early active flexion-extension exercises to initiate mobilization and multimodal analgesia will be provided. Patients in group A will receive perioperative care adapted to the drainage. All patients will have their baseline pain measured preoperatively and postoperatively using an analog rating scale. Patients will be checked if they require morphine rescue analgesia during their hospital stay. Postoperative pain assessment will be performed at discharge. Receives: Procedure: Redon drain |
| NO DRAINAGE GROUP (B) | No intervention | Patients in group B will not have a Redon drain placed at the end of the procedure. Both groups of patients will be explained early active flexion-extension exercises to initiate mobilization and multimodal analgesia will be provided. All patients will have their baseline pain measured preoperatively and postoperatively using an analog rating scale. Patients will be checked if they require morphine rescue analgesia during their hospital stay. Postoperative pain assessment will be performed at discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative baseline pain and postoperative pain at discharge
Preoperative baseline pain and postoperative pain at discharge, both assessed using an Analog Rating Scale (scale 0-10)
Measured: Preoperative baseline pain (Day 0) and postoperative pain at discharge (Day 2)
Secondary outcomes (1)
Body Mass Index
Weight in kilograms (kg) divided by the square of height in meters (m2)
Measured: BMI measured in Day 0 (at the time of admision in hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Jan 2025
- Primary completion1 Mar 2025
- Study completion12 Mar 2025
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
- Model description
- Comparative prospective clinical trial between 2 groups of randomly selected patients (30 patients each)
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jesús Castellano Curado, Hospital Universitario Reina Sofia de Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175883
- Sponsor's protocol ID
- HURSKNEEDRAIN
- Status last verified
- Sep 2025
- First submitted
- 4 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain in Primary Cemented Total Knee Arthroplasty With or Without Drain
- ClinicalTrials.gov ID
- NCT07175883
- Acronym / sponsor ID
- HURSKNEEDRAIN
- Conditions
- Postoperative Pain, Arthropathy of Knee
- Keywords
- drainage, Arthroplasty, Replacement, Knee, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Universitario Reina Sofia de CordobaOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 16 Sep 2025 (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 use of closed aspirative surgical drainage presents a truly questionable role in the field of orthopedic surgery.
The pathophysiological mechanisms on which it acts have been widely theorized, as well as the disadvantages that could be associated, both at a biological and socio-sanitary level, so that clinical guidelines opt to leave the decision to the surgeon's discretion.
Although its application and postoperative complications in knee arthroplasty are widely documented, the results are inconclusive and the scientific community does not seem to reach a consensus.
The main debate centers on bleeding during the immediate postoperative period, a classic complication of these interventions, but which seems to be being avoided with the introduction of new techniques and drugs, mainly the use of tranexamic acid.
However, a fundamental element of the postoperative period of these interventions that all the research seems to omit is pain in the postoperative period, which is key, as the pain of gonarthrosis is the main indication for the intervention.
It is because of this lack in the essential knowledge of this intervention that we propose the following hypothesis: the use of drainage in knee arthroplasty does not reduce pain during the early postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative prospective clinical trial between 2 groups of randomly selected patients (30 patients each)
| Arm | Type | Receives |
|---|---|---|
| DRAINAGE GROUP (A) | Experimental | Procedure: Redon drainPatients in group A will have a Redon drain placed at the end of the procedure. Both groups of patients will be explained early active flexion-extension exercises to initiate mobilization and multimodal analgesia will be provided. Patients in group A will receive perioperative care adapted to the drainage. All patients will have their baseline pain measured preoperatively and postoperatively using an analog rating scale. Patients will be checked if they require morphine rescue analgesia during their hospital stay. Postoperative pain assessment will be performed at discharge. |
| NO DRAINAGE GROUP (B) | No intervention | –Patients in group B will not have a Redon drain placed at the end of the procedure. Both groups of patients will be explained early active flexion-extension exercises to initiate mobilization and multimodal analgesia will be provided. All patients will have their baseline pain measured preoperatively and postoperatively using an analog rating scale. Patients will be checked if they require morphine rescue analgesia during their hospital stay. Postoperative pain assessment will be performed at discharge. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 60 years of age
- Candidates for hybrid total knee arthroplasty with preservation of the posterior cruciate ligament
Key exclusion criteria (3 listed)
- Patients with previous ipsilateral or contralateral knee surgery (contralateral knee arthroplasty, osteotomized, previous cruciate ligament or meniscal repair included)
- History of rheumatologic diseases
- History of articular infection
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 |
|---|---|---|
| Redon drainPatients in group A will have a Redon drain placed at the end of the procedure following the usual technique | Procedure or surgery | DRAINAGE GROUP (A) |
Primary outcome
Preoperative baseline pain and postoperative pain at discharge
Time frame: Preoperative baseline pain (Day 0) and postoperative pain at discharge (Day 2)
Preoperative baseline pain and postoperative pain at discharge, both assessed using an Analog Rating Scale (scale 0-10)
1 secondary outcome
Body Mass Index
Time frame: BMI measured in Day 0 (at the time of admision in hospital)
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 16 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Redon drain in people with Postoperative Pain and Arthropathy of Knee, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
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 2 inclusion and 3 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 16 Sep 2025. 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 Spain. 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?
Preoperative baseline pain and postoperative pain at discharge (time frame: Preoperative baseline pain (Day 0) and postoperative pain at discharge (Day 2)). 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 16 Sep 2025.