Analgesia, Postoperative Pain Management, Nephrolithiasis
Conditions
Brief summary
The goal of this clinical trial is to determine whether the erector spinae plane (ESP) block provides better pain relief after flexible ureterorenoscopy (URS) surgery compared to standard analgesia alone. Researchers want to know: Does the ESP block reduce pain levels in the first 24 hours after surgery? Does it lower the need for opioid pain medication? Does it reduce the need for additional (rescue) pain treatment? Does it decrease the likelihood of postoperative nausea and vomiting (PONV)? Participants will be randomly placed into one of two groups: ESP Block Group: Participants will receive an ESP block using 20 mL of 0.25% bupivacaine under ultrasound guidance before surgery. Control Group: Participants will receive standard pain management without a nerve block. All participants will receive general anesthesia during surgery and multimodal pain management after surgery. Researchers will compare pain scores, opioid use, rescue analgesic needs, and the occurrence of nausea and vomiting between the two groups.
Detailed description
Intervention Group (ESP Block): Patients will receive 20 mL of 0.25% bupivacaine (1:1 diluted with 0.5% bupivacaine) under ultrasound guidance at the T8-T10 level. Control Group: No block will be performed, and patients will receive standard postoperative multimodal analgesia. Procedure Description: The ESP block will be performed under sterile conditions with a high-frequency linear ultrasound probe. A 100-mm echogenic needle will be inserted in a cephalocaudal direction to deposit the local anesthetic deep to the erector spinae muscle at the transverse process level. The correct spread of the anesthetic will be confirmed via real-time ultrasound imaging. All patients will receive standardized general anesthesia and multimodal analgesia. Outcome measures include postoperative pain (NRS), opioid consumption, rescue analgesia requirement, and postoperative nausea and vomiting (PONV).
Interventions
PROCEDUREErector Spinae Plane (ESP) Block
A regional anesthesia technique in which 20 mL of 0.25% bupivacaine is injected under ultrasound guidance at the T8-T10 level to provide postoperative pain relief.
Sponsors
Namik Kemal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients undergoing elective flexible ureterorenoscopy (URS). Age: 18-65 years. ASA I-II. Willing to participate and provide written informed consent.
Exclusion criteria
BMI \>35 kg/m². Allergy to local anesthetics. Coagulation disorders or use of anticoagulants. Patients requiring emergency surgery. Patients with infection at the ESP block site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (Numeric Rating Scale - NRS) | 0, 2, 6, 12, 24 hours postoperatively. | The Numeric Rating Scale (NRS, 0-10) will be used to assess postoperative pain intensity. Participants will be asked to rate their pain on a scale from 0 to 10, where: * 0 = No pain * 10 = Worst possible pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption (IV PCA Morphine Equivalent) | From 0 hours (postoperatively) to 24 hours postoperatively, assessed at 0, 2, 6, 12, and 24 hours. | Description: Total opioid consumption will be recorded in morphine milligram equivalents (MME) administered via IV patient-controlled analgesia (PCA). |
| Postoperative Nausea and Vomiting (PONV) | From 0 hours (postoperatively) to 24 hours postoperatively, assessed at 0, 2, 6, 12, and 24 hours. | The incidence of postoperative nausea and vomiting (PONV) will be recorded, defined as nausea and/or vomiting requiring treatment with ondansetron IV. |
| Pain-Free Duration | From the end of surgery until the first request for pain medication, assessed up to 24 hours postoperatively. | Pain-free duration is defined as the time from the end of surgery to the first request for analgesia (when the patient reports pain requiring medication). |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORAyhan Şahin, Assoc. Prof.
Namik Kemal University
Outcome results
None listed