Clinical trial NCT06826833: ESP Block for Postoperative Analgesia in URS Surgery
Official title: Efficacy of Erector Spinae Plane Block in Flexible Ureterorenoscopy (URS) Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Postoperative Pain Management
Nephrolithiasis
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity (Numeric Rating Scale - NRS)
timeFrame: 0, 2, 6, 12, 24 hours postoperatively.
Secondary outcomes:
measure: Total Opioid Consumption (IV PCA Morphine Equivalent)
timeFrame: From 0 hours (postoperatively) to 24 hours postoperatively, assessed at 0, 2, 6, 12, and 24 hours.
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: From 0 hours (postoperatively) to 24 hours postoperatively, assessed at 0, 2, 6, 12, and 24 hours.
measure: Pain-Free Duration
timeFrame: From the end of surgery until the first request for pain medication, assessed up to 24 hours postoperatively.
Other outcomes:
Locations:
city: Tekirdağ
country: Turkey
facility: Tekirdağ Namık Kemal University Research Hospital
Study officials:
affiliation: Namik Kemal University
name: Ayhan Şahin, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
citation: Bryniarski P, Bialka S, Kepinski M, Szelka-Urbanczyk A, Paradysz A, Misiolek H. Erector Spinae Plane Block for Perioperative Analgesia after Percutaneous Nephrolithotomy. Int J Environ Res Public Health. 2021 Mar 31;18(7):3625. doi: 10.3390/ijerph18073625.