NCT07346872

Brief 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. 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
5mo left

Started Dec 2025

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Dec 2025Oct 2026

Study Start

First participant enrolled

December 26, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

December 28, 2025

Last Update Submit

January 8, 2026

Conditions

PainPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Quality of Recovery-15 (QoR-15) Score

    Postoperative 24 hours

  • Total Postoperative Tramadol Consumption (mg)

    Postoperative 24 hours]

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

    Postoperative 24 hours

  • Number of Participants Requiring Additional Postoperative Rescue Analgesia

    postoperative 24 hour

  • pinprick test

    postoperative 24 hour

Study Arms (2)

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.

Drug: TramadolProcedure: 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.

Drug: TramadolProcedure: epidural

Interventions

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.

Group : exora blockGroup:Epidural Analgesia
exora blockPROCEDURE

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

Group : exora block
epiduralPROCEDURE

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.

Group:Epidural Analgesia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Korgün Ökmen

Bursa, 16110, Turkey (Türkiye)

Location

University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

TramadolInjections, Epidural

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsInjections, SpinalInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2025

First Posted

January 16, 2026

Study Start

December 26, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations

TU(2)