PainNCT07346872
EXORA Block vs Epidural Analgesia in Gynecological Surgery
A study testing Tramadol, exora block and epidural in people with Pain and Postoperative Pain, run by Bursa Yuksek Ihtisas Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This prospective observational study aims to compare the effects of the EXORA block and epidural analgesia on postoperative pain control and quality of recovery in patients undergoing gynecological surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative Pain
- What is being tested?
- Tramadol, exora block and epidural
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 26 Dec 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80 years
- ASA (American Society of Anaesthetists) physical status classification I-III
- Undergoing elective gynecological surgery
- Receiving either EXORA block or epidural analgesia for postoperative pain management
Who cannot join
- Secondary or repeat surgical procedures
- Severe renal or hepatic dysfunction
- Body mass index (BMI) greater than 30 kg/m²
- Psychiatric or cognitive disorders impairing cooperation or questionnaire completion
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Korgün Ökmen
Bursa, 16110
University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,
Bursa
About this study
Official title: Comparison of EXORA Block and Epidural Analgesia on Quality of Recovery and Postoperative Analgesia Following Gynecological Surgery
This prospective observational study aims to compare the effects of the EXORA block and epidural analgesia on postoperative pain control and quality of recovery in patients undergoing gynecological surgery. Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, and postoperative pain will be evaluated using the Visual Analog Scale (VAS).
Read the detailed description
Effective postoperative analgesia is essential for improving recovery quality and patient satisfaction following gynecological surgery. Epidural analgesia is widely accepted as a standard technique for postoperative pain control; however, it may be associated with adverse effects such as hypotension and delayed mobilization. The EXORA block is an ultrasound-guided fascial plane block that has recently emerged as an alternative analgesic technique with a potentially favorable safety and recovery profile.
This prospective observational study compares postoperative recovery quality and analgesic efficacy between patients receiving EXORA block and those receiving epidural analgesia for postoperative pain management. Recovery quality will be objectively evaluated using the validated Quality of Recovery-15 (QoR-15) questionnaire.
- Conditions
- Pain, Postoperative Pain
- Being tested
- Tramadol, exora block, epidural
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
exora blockProcedure or surgery
Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed
epiduralProcedure or surgery
Thoracic epidural catheterization will be performed preoperatively at the Thoracic 8-Thoracic 10 levels. Postoperatively, a bolus dose of 10 ml of 0.25% local anesthetic will be administered followed by continuous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Group : exora block | Active comparator | Patients will receive an ultrasound-guided EXORA block for postoperative analgesia, performed by the attending anesthesiologist according to institutional clinical practice. Receives: Drug: Tramadol; Procedure: exora block |
| Group:Epidural Analgesia | Active comparator | Patients will receive epidural analgesia for postoperative pain control, administered by the attending anesthesiologist according to standard institutional protocols. Receives: Drug: Tramadol; Procedure: epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: Postoperative 24 hours
Secondary outcomes (5)
Quality of Recovery-15 (QoR-15) Score
The QoR-15 is a reliable and validated tool for assessing patient-reported postoperative recovery and provides a comprehensive evaluation of physical and emotional well-being after surgery.
Measured: Postoperative 24 hours
Total Postoperative Tramadol Consumption (mg)
Total amount of tramadol administered for postoperative analgesia will be recorded in milligrams during the first 24 hours after surgery.
Measured: Postoperative 24 hours]
Incidence and Severity of Postoperative Nausea and Vomiting Assessed by the Nausea and Vomiting Scale (NVS)
Postoperative nausea and vomiting will be assessed using the Nausea and Vomiting Scale (NVS), defined as:
0 = No nausea
- = Mild nausea
- = Severe nausea
- = Vomiting
In cases of an NVS score ≥3, an antiemetic drug will be administered.
Measured: Postoperative 24 hours
Number of Participants Requiring Additional Postoperative Rescue Analgesia
The number of participants requiring additional postoperative rescue analgesia beyond the standard analgesic protocol within the first 24 hours after surgery will be recorded.
Measured: postoperative 24 hour
pinprick test
The level of sensory block will be evaluated by pinprick test at 30 minutes following the block procedure and in postoperative patients.
With the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt.
Measured: postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start26 Dec 2025
- Primary completion1 Aug 2026
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346872
- Sponsor's protocol ID
- BursaYIEAH-2024
- Status last verified
- Oct 2026
- First submitted
- 28 Dec 2025
- Last updated
- 14 Oct 2026
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of EXORA Block and Epidural Analgesia on Quality of Recovery and Postoperative Analgesia Following Gynecological Surgery
- ClinicalTrials.gov ID
- NCT07346872
- Acronym / sponsor ID
- BursaYIEAH-2024
- Conditions
- Pain, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 16 Jan 2026 (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.
This prospective observational study aims to compare the effects of the EXORA block and epidural analgesia on postoperative pain control and quality of recovery in patients undergoing gynecological surgery. Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, and postoperative pain will be evaluated using the Visual Analog Scale (VAS).
Detailed description
Effective postoperative analgesia is essential for improving recovery quality and patient satisfaction following gynecological surgery. Epidural analgesia is widely accepted as a standard technique for postoperative pain control; however, it may be associated with adverse effects such as hypotension and delayed mobilization. The EXORA block is an ultrasound-guided fascial plane block that has recently emerged as an alternative analgesic technique with a potentially favorable safety and recovery profile.
This prospective observational study compares postoperative recovery quality and analgesic efficacy between patients receiving EXORA block and those receiving epidural analgesia for postoperative pain management. Recovery quality will be objectively evaluated using the validated Quality of Recovery-15 (QoR-15) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group : exora block | Active comparator | Drug: Tramadol, Procedure: exora blockPatients will receive an ultrasound-guided EXORA block for postoperative analgesia, performed by the attending anesthesiologist according to institutional clinical practice. |
| Group:Epidural Analgesia | Active comparator | Drug: Tramadol, Procedure: epiduralPatients will receive epidural analgesia for postoperative pain control, administered by the attending anesthesiologist according to standard institutional protocols. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 80 years
- ASA (American Society of Anaesthetists) physical status classification I-III
- Undergoing elective gynecological surgery
- Receiving either EXORA block or epidural analgesia for postoperative pain management
Key exclusion criteria (4 listed)
- Secondary or repeat surgical procedures
- Severe renal or hepatic dysfunction
- Body mass index (BMI) greater than 30 kg/m²
- Psychiatric or cognitive disorders impairing cooperation or questionnaire completion
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 |
|---|---|---|
| Tramadol400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg. | Drug | Group : exora block, Group:Epidural Analgesia |
| exora blockUltrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed | Procedure or surgery | Group : exora block |
| epiduralThoracic epidural catheterization will be performed preoperatively at the Thoracic 8-Thoracic 10 levels. Postoperatively, a bolus dose of 10 ml of 0.25% local anesthetic will be administered followed by continuous infusion. | Procedure or surgery | Group:Epidural Analgesia |
Primary outcome
NRS
Time frame: Postoperative 24 hours
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
5 secondary outcomes
Quality of Recovery-15 (QoR-15) Score
Time frame: Postoperative 24 hours
Total Postoperative Tramadol Consumption (mg)
Time frame: Postoperative 24 hours]
Incidence and Severity of Postoperative Nausea and Vomiting Assessed by the Nausea and Vomiting Scale (NVS)
Time frame: Postoperative 24 hours
Number of Participants Requiring Additional Postoperative Rescue Analgesia
Time frame: postoperative 24 hour
pinprick test
Time frame: postoperative 24 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tramadol, exora block and epidural in people with Pain and Postoperative Pain, run by Bursa Yuksek Ihtisas Training and Research Hospital at 2 sites 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 4 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: under way, not looking for participants, as of the sponsor's last update on 14 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 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
NRS (time frame: Postoperative 24 hours). 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 14 Oct 2026.