An interventional study of Tramadol and exora block in Pain and Postoperative Pain, sponsored by Bursa Yuksek Ihtisas Training and Research Hospital. Active, not recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Bursa Yuksek Ihtisas Training and Research Hospital · Not applicable, Interventional, and Treatment
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).
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.
2,216 studies on the registry are indexed under Pain; 915 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 1,901 interventional studies indexed under Pain.
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Exclusion Criteria:
Patients will receive an ultrasound-guided EXORA block for postoperative analgesia, performed by the attending anesthesiologist according to institutional clinical practice.
Drug: Tramadol · Procedure: exora block
Patients will receive epidural analgesia for postoperative pain control, administered by the attending anesthesiologist according to standard institutional protocols.
Drug: Tramadol · Procedure: epidural
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.
Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed
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.
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"
Time frame: Postoperative 24 hours
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.
Time frame: 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.
Time frame: 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 1. = Mild nausea 2. = Severe nausea 3. = Vomiting In cases of an NVS score ≥3, an antiemetic drug will be administered.
Time frame: 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.
Time frame: 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.
Time frame: postoperative 24 hour
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Bursa Yuksek Ihtisas Training and Research Hospital