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NCT Number: NCT07346872

EXORA Block vs Epidural Analgesia in 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).

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Key information

Conditions

Pain Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korgün Ökmen, Bursa, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol

Drug

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 block

Procedure

Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed

Epidural

Procedure

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.

Primary outcomes

  1. 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"

Secondary outcomes

  1. Quality of Recovery-15 (QoR-15) Score

    Time frame: Postoperative 24 hours

    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.

  2. Total Postoperative Tramadol Consumption (mg)

    Time frame: Postoperative 24 hours]

    Total amount of tramadol administered for postoperative analgesia will be recorded in milligrams during the first 24 hours after surgery.

  3. Incidence and Severity of Postoperative Nausea and Vomiting Assessed by the Nausea and Vomiting Scale (NVS)

    Time frame: Postoperative 24 hours

    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.

  4. Number of Participants Requiring Additional Postoperative Rescue Analgesia

    Time frame: postoperative 24 hour

    The number of participants requiring additional postoperative rescue analgesia beyond the standard analgesic protocol within the first 24 hours after surgery will be recorded.

  5. pinprick test

    Time frame: postoperative 24 hour

    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.

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Comparison of EXORA Block and Epidural Analgesia on Quality of Recovery and Postoperative Analgesia Following Gynecological Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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