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

Andalusian Health Service

Status: Completed

Conditions: Postoperative Pain; Arthropathy of Knee

Treatments: Procedure: Redon drain

Study type: Interventional

Funder types: Other

Identifiers

NCT07175883

HURSKNEEDRAIN

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

DRAINAGE GROUP (A)

Experimental group

Description:

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.

Treatment:

Procedure: Redon drain

NO DRAINAGE GROUP (B)

No Intervention group

Description:

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.