Comparison of Epidural Analgesia With Intra-Articular Infiltration Analgesia

March 10, 2025 updated by: Ahmet Gültekin, Namik Kemal University

Comparison of Epidural Analgesia With Intra-Articular Infiltration Analgesia for Postoperative Total Knee Arthroplasty Analgesia: A Prospective, Randomized Controlled Trial

The results of combining infiltrative analgesia applied by orthopedists with epidural analgesia applied by anesthesiologists after knee replacement surgery will be compared.

It aims to compare epidural analgesia with the maximum reduction of postoperative pain in patients, as well as in terms of both analgesic and complications.

The study will include patients who have undergone knee replacement surgery for six months. In the study, we will compare the results of painkillers applied to the patient from the waist or knee after the waist numbing anesthesia, which includes some of the routinely applied protocols of your knee replacement surgery. It is a condition that will be monitored after surgery. The study aims to reduce maximum pain with two painkiller methods applied in small amounts or together. No interventional application will be made to the patient who will undergo surgery other than routine application. After the surgery, you will be asked verbally about your pain level and side effects at certain hours after the surgery and the amount of painkillers used and the amount of painkillers will be determined according to the follow-up hours (1st, 2nd, 6th, 12th, 24th and 48th hours after the surgery). In addition to these, complications will also be monitored. The results of patients who can be fully followed up at the end of 6 months will be presented as a scientific study.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age range 18-75
  2. Those who underwent surgery with combined spinal anesthesia
  3. Drugs administered with combined spinal anesthesia and intra-articular infiltration analgesia

Exclusion Criteria:

  1. Those who do not want to participate in the study
  2. Those who underwent surgery under general anesthesia
  3. Patients outside the specified age range
  4. Patients with inadequate follow-up results (patient, drug and device related)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Analgesia provided only with epidural analgesia
Other: Recording the amount of medication and the number of complications according to observational follow-up
Observational monitoring of patients and recording data for 24 hours
Active Comparator: Analgesia provided with epidural analgesia and local infiltration
Other: Recording the amount of medication and the number of complications according to observational follow-up
Observational monitoring of patients and recording data for 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of local anesthetic used for epidural analgesia
Time Frame: 6 months
Is there a statistical difference between the two groups? Monitoring the effect of local infiltration on the amount of epidural analgesic agent
6 months
Differences between the two groups in terms of complications and need for additional analgesia
Time Frame: 6 months
The effect of epidural analgesia and infiltration analgesia on complications and additional analgesia needs in patients
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namik Kemal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 28, 2025

Primary Completion (Estimated)

September 28, 2025

Study Completion (Estimated)

September 28, 2025

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NamikKU-AGultekin-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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