ESP Block vs. EXORA Block for Postoperative Pain in Nephrectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBakirkoy Dr. Sadi Konuk Research and Training Hospital
About this trial
The goal of this observational study is to learn about the effects of two pain control techniques used after laparoscopic nephrectomy (kidney removal surgery) in adults. The study will compare Erector Spinae Plane (ESP) block and External Oblique Rectus Abdominis (EXORA) block, which are both used as part of routine medical care to help control pain after surgery.
The main questions it aims to answer are:
Do ESP block and EXORA block differ in how well they control pain after surgery? Do ESP block and EXORA block differ in their effects on recovery quality and the need for additional pain medication?
Researchers will compare participants who receive ESP block with participants who receive EXORA block as part of routine clinical care.
Participants will:
Undergo laparoscopic nephrectomy according to routine clinical practice. Receive either ESP block or EXORA block based on the treating anesthesiologist's usual clinical preference.
Complete a recovery questionnaire before surgery and 24 hours after surgery. Have pain scores, use of additional pain medication, nausea and vomiting, and other routine postoperative measurements recorded during the first 24 hours after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years
Patients scheduled for laparoscopic nephrectomy
Patients for whom Erector Spinae Plane (ESP) block or External Oblique Rectus Abdominis (EXORA) block has been selected by the treating clinician
ASA physical status I-III
Disqualifiers
No regional block performed in routine clinical practice
Body mass index (BMI) greater than 35 kg/m²
History of opioid dependence
Alcohol or other substance dependence
Trial population
Adult patients aged 18-80 years undergoing laparoscopic nephrectomy and receiving either an Erector Spinae Plane (ESP) block or an External Oblique Rectus Abdominis (EXORA) block according to routine clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Erector Spinae Plane Block
Procedure/SurgeryAn ultrasound-guided Erector Spinae Plane (ESP) block is performed under general anesthesia prior to extubation as part of routine clinical practice. After aseptic preparation, a linear ultrasound probe is placed over the T10 transverse process on the surgical side. The needle is advanced into the fascial plane between the erector spinae muscle and the transverse process. Following negative aspiration and confirmation of correct needle placement with hydrodissection, 30 mL of 0.25% bupivacaine is injected. The procedure is performed by anesthesiologists according to routine clinical practice without researcher involvement in clinical decision-making.
External Oblique Rectus Abdominis Block
Procedure/SurgeryAn ultrasound-guided External Oblique Rectus Abdominis (EXORA) block is performed under general anesthesia prior to extubation as part of routine clinical practice. After aseptic preparation, a linear ultrasound probe is positioned in the parasternal sagittal plane lateral to the xiphoid process at the level of the 8th costal cartilage on the surgical side. The needle is advanced into the fascial plane between the rectus abdominis and external oblique muscles. Following negative aspiration and confirmation of correct needle placement with hydrodissection, 30 mL of 0.25% bupivacaine is injected. The procedure is performed by anesthesiologists according to routine clinical practice without researcher involvement in clinical decision-making.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Group E1 intervention
Group B: Group X1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Pain Score (NRS)
Postoperative pain will be assessed using the Numeric Rating Scale (NRS, 0-10). Pain scores will be recorded at 1, 6, 12, and 24 hours after surgery and will be compared between Group E and Group X. The Numeric Rating Scale ranges from 0 to 10 (0 = no pain, 10 = worst imaginable pain); higher scores indicate worse pain.
Time frame
Postoperative 1, 6, 12, and 24 hoursSecondary outcomes
1
Rescue Analgesic Requirement
The requirement for rescue analgesia and the total amount of postoperative tramadol consumption during the first 24 hours will be recorded and compared between Group E and Group X.
Time frame
First 24 hours after surgery2
Quality of Recovery (QoR-15 Score)
Quality of recovery will be assessed using the validated Quality of Recovery-15 (QoR-15) questionnaire. Scores will be compared between Group E and Group X. The QoR-15 total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
Time frame
Preoperative baseline and postoperative 24th hourOther outcomes
1
Postoperative Nausea and Vomiting (PONV) Score
Postoperative nausea and vomiting will be assessed using a verbal descriptive scale from 0 to 4 (0 = none, 1 = mild, 2 = moderate, 3 = single vomiting episode, 4 = multiple vomiting episodes). Scores will be compared between Group E and Group X.
Time frame
Postoperative 1, 6, 12, and 24 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov