An observational study in Chronic Sinusitis, Postoperative Pain and Postoperative Nausea and Vomiting (PONV), sponsored by Filiz Kaya. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Filiz Kaya · Observational
Among 1,093 studies in Pain, Postoperative with a site in Turkey — 262 open to participants now, 294 under way, none of them phase 3. Pain, Postoperative · Turkey.
Among the 1,093 studies in Pain, Postoperative with a site in Turkey, this one is the 61st largest by planned enrollment of the 215 observational ones that give a count, is one of 218 that started in 2026, is one of 215 observational ones, reaches primary completion later than 265 of the 293 other live ones, and was the 1,026th registered.
5,644 studies on the registry are indexed under Pain, Postoperative; 1,229 are open to participants now.
Browse Pain, Postoperative studies →262 of the 1,093 studies in Pain, Postoperative with a site in Turkey are open now. Recruiting first, the newest first:
Kocaeli City Hospital · Sites in Turkey
Ages 8–18 · Healthy volunteers
Bursa City Hospital · Sites in Turkey
Ages 18–85 · Women only
Van Training and Research Hospital · Sites in Turkey
Ages 18–65
Istanbul University · Sites in Turkey
Ages 1–12
Ankara City Hospital Bilkent · Sites in Turkey
Ages 60+ · Healthy volunteers
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 678 Pain, Postoperative studies recruiting now, 241 (36%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,093 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 4 · Phase 3 2 · Phase 4 59
First in 2009; this study’s year is marked. 218 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 104 is close to the median of 102 across 683 observational studies indexed under Pain, Postoperative.
Median enrollment 70 across the 878 interventional studies, 80 across the 215 observational. Of the 748 that completed or were terminated, 9 (1%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 1,093 have an industry lead sponsor. The 10 most frequent:
Filiz Kaya is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Filiz Kaya has 1 study filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
131 of the studies in Pain, Postoperative with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07659990Ferit YetikRISS Versus SPSIP Block in Modified Radical Mastectomy | 2026-11 |
| NCT07524673Cumhuriyet UniversityComprasion of SPSIP and Rhomboid Intercostal Plan Blocks on VATS | 2026-11 |
| NCT07561853Sakarya UniversitySerratus Posterior Superior vs Erector Spinae Plane Block for Breast Surgery | 2026-11-15 |
| NCT07650877Ankara City Hospital BilkentComparison of the Rhomboid Intercostal Block and Serratus Posterior Superior Intercostal Plane Block | 2026-11-20 |
| NCT07436806Medipol UniversitySPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery | 2026-11-20 |
Add all 131 to your calendar (.ics) → With an account.
Among the 1,093 studies in Pain, Postoperative with a site in Turkey, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Information for Patients and Families What is this study about? When patients undergo functional endoscopic sinus surgery (FESS), strong pain relievers called opioids are traditionally used during anesthesia. While effective, opioids can sometimes cause unwanted side effects such as nausea, vomiting, dizziness, or prolonged recovery times. This study investigates an "Opioid-Free Anesthesia" (OFA) approach combined with Enhanced Recovery After Surgery (ERAS) protocols. ERAS is a modern, science-based care pathway designed to help patients recover faster and more comfortably after surgery.
Why is this study important? The goal of this study is to see if skipping opioids during sinus surgery-and using alternative pain-management techniques instead-leads to better perioperative outcomes. We want to find out if patients experience less pain, fewer side effects (like nausea), and a quicker, safer return to their daily routines.
What will happen if you participate? If you fit the criteria and agree to join, your surgical journey will follow the standard ERAS protocol, but your anesthesia will be managed without conventional opioid medications. Researchers will closely monitor your comfort, pain levels, and recovery speed before, during, and after your sinus surgery.
Study Design: Prospective, Observational Study. Estimated Enrollment: 104 patients. Setting: Perioperative tracking following strict institutional ERAS principles.
This prospective observational study is designed to evaluate perioperative clinical outcomes in patients undergoing elective Functional Endoscopic Sinus Surgery (FESS) under routine clinical care. In accordance with the observational nature of the study, the investigators do not assign or control the anesthetic techniques, drug dosages, or clinical pathways. All perioperative interventions, including the choice between an opioid-free anesthesia (OFA) approach or traditional opioid-based anesthesia, are determined solely by the attending anesthesiologists based on standard institutional protocols and clinical judgment.
Data collection will encompass the entire perioperative period, spanning from the pre-anesthesia assessment until the standard post-operative follow-up intervals.
The clinical tracking workflow consists of the following phases:
Statistical analyses will be performed to evaluate and compare the collected perioperative datasets between patients who received dexmedetomidine-based opioid-free anesthesia and those who received traditional opioid-based regimens under the institutional Enhanced Recovery After Surgery (ERAS) framework. No additional clinical interventions, blood samplings, or changes to standard patient care pathways are introduced due to study participation.
Adult male and female patients aged 18 to 65 years who are scheduled to undergo elective Functional Endoscopic Sinus Surgery (FESS) due to chronic sinusitis at Ankara Bilkent City Hospital, a tertiary care referral and teaching hospital in Ankara, Turkey. The study population comprises consecutive eligible patients whose perioperative anesthetic and surgical management is monitored following institutional Enhanced Recovery After Surgery (ERAS) pathways.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing elective Functional Endoscopic Sinus Surgery (FESS) who receive dexmedetomidine-based Opioid-Free Anesthesia (OFA) embedded within an Enhanced Recovery After Surgery (ERAS) pathway. No intraoperative opioids will be administered to this cohort.
Drug: Dexmedetomidine
Patients undergoing elective Functional Endoscopic Sinus Surgery (FESS) who receive traditional remifentanil-based opioid anesthesia embedded within the same Enhanced Recovery After Surgery (ERAS) pathway.
Drug: Remifentanil
Patients in the Opioid-Free Anesthesia (OFA) cohort receive general anesthesia maintained via Total Intravenous Anesthesia (TIVA) with a propofol infusion. Intraoperative analgesia and hemodynamic control are managed using a dexmedetomidine infusion combined with non-opioid multimodal analgesics, embedded within an institutional ERAS pathway. Brain function monitoring (Masimo SedLine®) is used to guide anesthesia depth. No intraoperative systemic opioids are administered.
Patients in the Opioid (O) cohort receive general anesthesia maintained via Total Intravenous Anesthesia (TIVA) using a propofol infusion. Intraoperative analgesia is provided through a traditional remifentanil-based continuous intravenous infusion protocol, managed within the same institutional ERAS pathway.
Quality of the Surgical Field Assessed by Fromme-Boezaart Scoring System
Comparison of the surgical field quality between the Opioid-Free Anesthesia (OFA) group and the traditional opioid group. The quality of the surgical field visibility will be evaluated by the operating surgeon using a validated visual scoring system, such as the Fromme-Boezaart Surgical Field Scoring System (ranging from 0 = no bleeding to 5 = severe bleeding, where lower scores indicate better surgical conditions).
Time frame: Perioperative/Periprocedural
Surgeon Satisfaction Score Assessed by a 5-Point Likert Scale
Assessment of the operating surgeon's overall satisfaction regarding the surgical conditions, field visibility, and patient immobility during the procedure. It will be evaluated using a 5-point Likert scale (ranging from 1 = Very Dissatisfied to 5 = Very Satisfied, where higher scores indicate a higher level of surgeon satisfaction)
Time frame: Immediately after the completion of the surgical procedure.
Heart Rate (HR)
Comparison of intraoperative heart rate (measured in beats per minute) between the two study cohorts to evaluate hemodynamic stability. Measurements will be recorded at predefined standard surgical intervals from anesthesia induction until extubation.
Time frame: Perioperative/Periprocedural
Postoperative Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)
Evaluation and comparison of the patient's subjective sleep quality during the first postoperative week between the two study cohorts. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which ranges from a minimum score of 0 to a maximum score of 21. A higher global score indicates worse sleep quality.
Time frame: Postoperative Day 7
Mean Arterial Pressure (MAP)
Comparison of intraoperative mean arterial pressure (measured in mmHg) between the two study cohorts to evaluate hemodynamic stability. Measurements will be recorded at predefined standard surgical intervals from anesthesia induction until extubation.
Time frame: Perioperative/Periprocedural
Severity of Postoperative Nausea and Vomiting (PONV)
Evaluation and comparison of the severity of postoperative nausea and vomiting between the two study cohorts. The severity of PONV will be assessed using a validated Visual Analog Scale (VAS) scoring system adapted from the literature: 0 = No nausea; 1 = Mild nausea; 2 = Moderate nausea; 3 = Severe nausea/vomiting. Lower scores indicate a lower burden of opioid-induced emetic side effects.
Time frame: Postoperative 24 hours
Plan to share: No — Individual participant data will not be made publicly available due to institutional ethical committee restrictions, legal data protection regulations (KVKK), and the need to maintain strict patient privacy.
Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.
Of 391 non-industry observational studies under Pain, Postoperative, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 12 months is close to that.
Counting every sponsor, half of 395 studies reached it within 13 months; a quarter within 5 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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Filiz Kaya