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OpenTrials
Completed

NCT Number: NCT07175883

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Unievrsitario Reina Sofia de Córdoba

Córdoba, CORDOBA, 14004, Spain

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Redon drain

Procedure

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Body Mass Index

    Time frame: BMI 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 outcomes

  1. Use of opioid rescue during hospital stay

    Time frame: Measured the day of medical discharge, on average postoperative day 2

    Total opioid rescue doses administered throughout the entire period of hospitalization following surgery until medical discharge

Sponsors and collaborators

Lead sponsor

Hospital Universitario Reina Sofia de Cordoba

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

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

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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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