Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 9:29 PM
Study NCT ID:
NCT06826833
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ESP Block for Postoperative Analgesia in URS Surgery
Sponsor:
Namik Kemal University
Organization:
Study Overview
Official Title:
Efficacy of Erector Spinae Plane Block in Flexible Ureterorenoscopy (URS) Surgery: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESPURS
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.
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: