Epidural; AnalgesiaNCT06872528
Comparison of Epidural Analgesia With Intra-Articular Infiltration Analgesia
A study testing Recording the amount of medication and the number of complications according to observational follow-up in people with Epidural; Analgesia and Local Infiltration, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Epidural; Analgesia, Local Infiltration
- What is being tested?
- Recording the amount of medication and the number of complications according to observational follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range 18-75
- Those who underwent surgery with combined spinal anesthesia
- Drugs administered with combined spinal anesthesia and intra-articular infiltration analgesia
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekirdağ Namık Kemal University Hospital
Tekirdağ
About this study
Official title: 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.
- Conditions
- Epidural; Analgesia, Local Infiltration
- Being tested
- Recording the amount of medication and the number of complications according to observational follow-up
- Keywords
- Ranawat, Epidural analgesia, Knee replacement surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording the amount of medication and the number of complications according to observational follow-upOther
Observational monitoring of patients and recording data for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Analgesia provided only with epidural analgesia | Active comparator | Not described Receives: 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 | Not described Receives: Other: Recording the amount of medication and the number of complications according to observational follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start15 Apr 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epidural; AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Gültekin, Namik Kemal University
- Investigators
- Ahmet Gültekin, MD, Principal investigator, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872528
- Sponsor's protocol ID
- NamikKU-AGultekin-2
- Status last verified
- Oct 2026
- First submitted
- 24 Feb 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 30021587Liu 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Epidural Analgesia With Intra-Articular Infiltration Analgesia for Postoperative Total Knee Arthroplasty Analgesia: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06872528
- Acronym / sponsor ID
- NamikKU-AGultekin-2
- Conditions
- Epidural; Analgesia, Local Infiltration
- Keywords
- Ranawat, Epidural analgesia, Knee replacement surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age range 18-75
- Those who underwent surgery with combined spinal anesthesia
- Drugs administered with combined spinal anesthesia and intra-articular infiltration analgesia
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recording the amount of medication and the number of complications according to observational follow-upObservational monitoring of patients and recording data for 24 hours | Other | Analgesia provided only with epidural analgesia, Analgesia provided with epidural analgesia and local infiltration |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 30021587Berninger 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.
- Background: PubMed 33126306Liu 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.
Related trials for Epidural; Analgesia
Not yet recruitingObservational study
Perfusion Index Variability During Epidural Labor Analgesia
Labor Epidural Analgesia, Perfusion Index
RecruitingObservational study
Failing Epidural Analgesia During Labor
Failed Epidural Analgesia, Post-partum Recovery
Recruiting
EpiFaith Resident Learning Curve Trial
Epidural Analgesia, Epidural Analgesia for Labour and Delivery
Recruiting
Integrated Intrapartum Supportive Care and Pushing Strategies in Women Receiving Low-Dose Epidural Analgesia
Labor, Obstetric, Epidural Analgesia, Obstetric
RecruitingObservational study
Neuraxial Labor Analgesia and Offspring Neurodevelopment
Pregnant Women, Labor Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Gültekin, MD principal investigator
Namik Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recording the amount of medication and the number of complications according to observational follow-up in people with Epidural; Analgesia and Local Infiltration, run by Namik Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of local anesthetic used for epidural analgesia (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06872528, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.