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

NCT07175883 | Completed

• 1 other identifier: HURSKNEEDRAIN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

drainage; Arthroplasty, Replacement, Knee; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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)

  Preoperative baseline pain (Day 0) and postoperative pain at discharge (Day 2)

Secondary Outcomes (1)

• Body Mass Index

  BMI measured in Day 0 (at the time of admision in hospital)

Other Outcomes (1)

• Use of opioid rescue during hospital stay

  Measured the day of medical discharge, on average postoperative day 2

Study Arms (2)

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.

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.

Interventions

Redon drain PROCEDURE

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

DRAINAGE GROUP (A)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Reina Sofia de Cordoba: lead

Study Sites (1)

Hospital Unievrsitario Reina Sofia de Córdoba

Córdoba, CORDOBA, 14004, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: September 16, 2025
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: March 12, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)