Postoperative PainNCT05910281
Rebound Pain and Related Factors in Postoperative Patients With Total Knee Arthroplasty
An observational study of Postoperative Pain and Postoperative Complications, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective observational study is to detect rebound pain and related factors in postoperative patients with total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Postoperative Complications, Postoperative Nausea and Vomiting
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 1 Dec 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - 18-80 years older age who underwent total knee arthroplasty
Who may be able to join
- 18-80 years older age who underwent total knee arthroplasty
Who cannot join
- ASA score 4 or >4
- Active infection
- End stage organ failure
- Pregnancy
- Established diagnosis neuropsychiatric disease ( epilepsy, neuropathy, neuromuscular disease, cerebrovascular disease...)
- Uses of oral corticosteroids
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Ankara, None Selected, 10100
Eyup Horasanli, eyuphorasanli@gmail.com
About this study
Official title: Rebound Pain and Related Factors in Patients Who Underwent Femoral Nerve Block for Postoperative Pain Control in Total Knee Arthroplasty
The aim of this prospective observational study is to detect rebound pain and related factors in postoperative patients with total knee arthroplasty.
Read the detailed description
Total knee arthroplasty is an effective treatment method for knee osteoarthritis and because it is an invasive method, more than 50% of patients experience postoperative pain. Peripheral nerve blocks are widely used for optimal pain control. The femoral block is a frequently preferred peripheral nerve block method for postoperative analgesia in total knee arthroplasty surgery. However, after peripheral nerve block, a condition called rebound pain (rebound pain), which is described as very severe pain, lasting about 2 hours, usually of the burning type, occurs. The aim of this prospective observational study is to detect rebound pain and related factors in postoperative patients with total knee arthroplasty.
- Medical subject headings
- Pain, Postoperative, Postoperative Complications, Postoperative Nausea and Vomiting
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: postoperative 3-5 days fellow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jul 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bilal Katipoglu, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910281
- Sponsor's protocol ID
- E2-23-4135
- Status last verified
- Jul 2023
- First submitted
- 9 Jun 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebound Pain and Related Factors in Patients Who Underwent Femoral Nerve Block for Postoperative Pain Control in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05910281
- Acronym / sponsor ID
- E2-23-4135
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 Jun 2023 (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 aim of this prospective observational study is to detect rebound pain and related factors in postoperative patients with total knee arthroplasty.
Detailed description
Total knee arthroplasty is an effective treatment method for knee osteoarthritis and because it is an invasive method, more than 50% of patients experience postoperative pain. Peripheral nerve blocks are widely used for optimal pain control. The femoral block is a frequently preferred peripheral nerve block method for postoperative analgesia in total knee arthroplasty surgery. However, after peripheral nerve block, a condition called rebound pain (rebound pain), which is described as very severe pain, lasting about 2 hours, usually of the burning type, occurs. The aim of this prospective observational study is to detect rebound pain and related factors in postoperative patients with total knee arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - 18-80 years older age who underwent total knee arthroplasty
Key inclusion criteria (1 listed)
- 18-80 years older age who underwent total knee arthroplasty
Key exclusion criteria (6 listed)
- ASA score 4 or >4
- Active infection
- End stage organ failure
- Pregnancy
- Established diagnosis neuropsychiatric disease ( epilepsy, neuropathy, neuromuscular disease, cerebrovascular disease...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analogue Scale
Time frame: postoperative 3-5 days fellow-up
The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Postoperative Complications, run by Gulhane Training and Research Hospital 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bilal Katipoglu (+905543330380, drbilal07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: postoperative 3-5 days fellow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2023.