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Comparison of Postoperative Pain in Primary Cemented Total Knee Arthroplasty With or Without Drain

Comparison of Postoperative Pain in Primary Cemented Total Knee Arthroplasty With or Without Drain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07175883
Enrollment
60
Registered
2025-09-16
Start date
2025-01-01
Completion date
2025-03-12
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Knee, Postoperative Pain

Keywords

drainage, Arthroplasty, Replacement, Knee, Postoperative Pain

Brief 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 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.

Interventions

PROCEDURERedon drain

Patients in group A will have a Redon drain placed at the end of the procedure following the usual technique

Sponsors

Hospital Universitario Reina Sofia de Cordoba
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Comparative prospective clinical trial between 2 groups of randomly selected patients (30 patients each)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients over 60 years of age * Candidates for hybrid total knee arthroplasty with preservation of the posterior cruciate ligament

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Preoperative baseline pain and postoperative pain at dischargePreoperative 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)

Secondary

MeasureTime frameDescription
Body Mass IndexBMI measured in Day 0 (at the time of admision in hospital)Weight in kilograms (kg) divided by the square of height in meters (m2)

Other

MeasureTime frameDescription
Use of opioid rescue during hospital stayMeasured the day of medical discharge, on average postoperative day 2Total opioid rescue doses administered throughout the entire period of hospitalization following surgery until medical discharge

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026