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Not yet recruitingNCT06872528Updated Mar 12, 2025

Comparison of Epidural Analgesia With Intra-Articular Infiltration Analgesia

An interventional study of Recording the amount of medication and the number of complications according to observational follow-up in Epidural; Analgesia and Local Infiltration, sponsored by Namik Kemal University. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-12.

Sponsored by Namik Kemal University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Epidural; Analgesia
  • Local Infiltration

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Keywords

  • Ranawat
  • Epidural analgesia
  • Knee replacement surgery
03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's planned enrollment of 30 is below the median of 78 across 1,024 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Namik Kemal University is the lead sponsor of 57 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Analgesia provided only with epidural analgesia

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

  • 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

Interventions

  • OtherRecording the amount of medication and the number of complications according to observational follow-up

    Observational monitoring of patients and recording data for 24 hours

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

  2. 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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 30021587 ↗
  • 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. PubMed 33126306 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06872528
Lead sponsor
Namik Kemal University
Responsible party
Ahmet Gültekin (Associate Professor, Namik Kemal University) — Principal investigator
First posted
Mar 12, 2025
Start date
Mar 28, 2025 (estimated)
Primary completion
Sep 28, 2025 (estimated)
Completion
Sep 28, 2025 (estimated)
Last update
Mar 12, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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