EXORA Block vs Epidural Analgesia in Gynecological Surgery

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Postoperative Pain
• Intervention / Treatment: Drug: Tramadol; Procedure: exora block; Procedure: epidural

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Bursa, Turkey (Türkiye)
    • University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,
  • Bursa, Turkey (Türkiye), 16110
    • Korgün Ökmen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group : exora block; Patients will receive an ultrasound-guided EXORA block for postoperative analgesia, performed by the attending anesthesiologist according to institutional clinical practice.	Drug: Tramadol; 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.; Procedure: exora block; Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed
Active Comparator: Group:Epidural Analgesia; Patients will receive epidural analgesia for postoperative pain control, administered by the attending anesthesiologist according to standard institutional protocols.	Drug: Tramadol; 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.; Procedure: epidural; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	postoperative 24 hour

Collaborators and Investigators

• Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Pain, Postoperative; Organic Chemicals; Therapeutics; Lipids; Drug Administration Routes; Drug Therapy; Amines; Alcohols; Cyclohexanols; Hexanols; Fatty Alcohols; Dimethylamines; Methylamines; Injections; Injections, Spinal; Tramadol; Injections, Epidural
• Other Study ID Numbers: BursaYIEAH-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No