EXORA Block vs Epidural Analgesia in Gynecological Surgery

Bursa Yuksek Ihtisas Training and Research Hospital

Status: Active, not recruiting

Conditions: Postoperative Pain; Pain

Treatments: Procedure: exora block; Drug: Tramadol; Procedure: epidural

Study type: Interventional

Funder types: Other

Identifiers

NCT07346872

BursaYIEAH-2024

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Group : exora block

Active Comparator group

Description:

Patients will receive an ultrasound-guided EXORA block for postoperative analgesia, performed by the attending anesthesiologist according to institutional clinical practice.

Treatment:

Drug: Tramadol

Procedure: exora block

Group:Epidural Analgesia

Active Comparator group

Description:

Patients will receive epidural analgesia for postoperative pain control, administered by the attending anesthesiologist according to standard institutional protocols.

Treatment:

Procedure: epidural

Drug: Tramadol