Comparison of Epidural Analgesia With Intra-Articular Infiltration Analgesia

NCT06872528 | Not Yet Recruiting

• 1 other identifier: NamikKU-AGultekin-2
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Epidural; Analgesia; Local Infiltration

Keywords

Ranawat; Epidural analgesia; Knee replacement surgery

Outcome Measures

Primary Outcomes (2)

• Amount of local anesthetic used for epidural analgesia

  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

  The effect of epidural analgesia and infiltration analgesia on complications and additional analgesia needs in patients

  6 months

Study Arms (2)

Analgesia provided only with epidural analgesia

ACTIVE COMPARATOR

Other: Recording the amount of medication and the number of complications according to observational follow-up

Analgesia provided with epidural analgesia and local infiltration

ACTIVE COMPARATOR

Other: Recording the amount of medication and the number of complications according to observational follow-up

Interventions

Recording the amount of medication and the number of complications according to observational follow-up OTHER

Observational monitoring of patients and recording data for 24 hours

Analgesia provided only with epidural analgesia; Analgesia provided with epidural analgesia and local infiltration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Namik Kemal University: lead

Related Publications (2)

• Berninger MT, Friederichs J, Leidinger W, Augat P, Buhren V, Fulghum C, Reng W. Effect of local infiltration analgesia, peripheral nerve blocks, general and spinal anesthesia on early functional recovery and pain control in total knee arthroplasty. BMC Musculoskelet Disord. 2018 Jul 18;19(1):232. doi: 10.1186/s12891-018-2154-z.

  PMID: 30021587 BACKGROUND

• Liu X, Zhang H, Zhang H, Guo M, Gao Y, Du C. Local infiltration vs epidural analgesia for postoperative pain control after total knee or hip arthroplasty: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020 Oct 30;99(44):e22674. doi: 10.1097/MD.0000000000022674.

  PMID: 33126306 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 12, 2025
• Study Start: March 28, 2025
• Primary Completion: September 28, 2025
• Study Completion: September 28, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03