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

NCT ID: NCT07175883

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-03-12

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.

Conditions

Postoperative Pain; Arthropathy of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DRAINAGE GROUP (A)

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.

Group Type: EXPERIMENTAL

Redon drain

Intervention Type: PROCEDURE

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

NO DRAINAGE GROUP (B)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Redon drain

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Reina Sofia de Cordoba

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jesús Castellano Curado

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Unievrsitario Reina Sofia de Córdoba

Córdoba, CORDOBA, Spain

Countries

Spain

Other Identifiers

HURSKNEEDRAIN

Identifier Type: -

Identifier Source: org_study_id