Bursa City Hospital
Bursa, Nilüfer, 16100, Turkey (Türkiye)
Location status: Recruiting
Location contact
Mürsel Ekinci, MD
PRINCIPAL_INVESTIGATOR
Yusuf Alan, MD
CONTACT
Yusuf Alan, MD
SUB_INVESTIGATOR
CONTACT
NCT Number: NCT07655323
This prospective randomized controlled trial aims to compare the analgesic efficacy and effects on diaphragmatic function of bilateral erector spinae plane (ESP) block and bilateral rhomboid intercostal-subserratus plane (RISS) block in patients undergoing elective laparoscopic cholecystectomy. Postoperative pain scores, opioid consumption, diaphragmatic excursion, pulmonary function, and recovery outcomes will be evaluated.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Bursa, Nilüfer, 16100, Turkey (Türkiye)
Location status: Recruiting
Mürsel Ekinci, MD
PRINCIPAL_INVESTIGATOR
Yusuf Alan, MD
CONTACT
Yusuf Alan, MD
SUB_INVESTIGATOR
CONTACT
Postoperative pain after laparoscopic cholecystectomy may impair respiratory function and delay recovery. Fascial plane blocks have emerged as effective opioid-sparing analgesic techniques. The erector spinae plane (ESP) block and rhomboid intercostal-subserratus plane (RISS) block are ultrasound-guided regional anesthesia techniques that may provide effective postoperative analgesia while preserving respiratory mechanics.
This prospective randomized controlled study will compare bilateral ESP block and bilateral RISS block in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. The primary objective is to compare postoperative analgesic efficacy and diaphragmatic function. Secondary outcomes include postoperative opioid consumption, pain scores at rest and during movement, pulmonary function parameters, rescue analgesic requirements, and adverse events.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-
Exclusion criteria
Bilateral ultrasound-guided erector spinae plane block performed before laparoscopic cholecystectomy for postoperative analgesia.
Bilateral ultrasound-guided rhomboid intercostal-subserratus plane block performed before laparoscopic cholecystectomy for postoperative analgesia.
Time frame: 24 hours after surgery
Total tramadol consumption during the first 24 hours after laparoscopic cholecystectomy.
Time frame: 0-24 hours after surgery
Postoperative pain scores assessed using the Numeric Rating Scale (NRS).
Time frame: 24 hours after surgery
Time from the end of surgery to first rescue analgesic requirement.
Time frame: During surgery
Total remifentanil consumption during surgery.
Time frame: 24 hours after surgery
Incidence of nausea, vomiting, pruritus and other opioid-related adverse events.
Time frame: 24 hours after surgery
Complications associated with ESP block or RISS block.
Time frame: Preoperative and postoperative 24 hours
Right hemidiaphragm excursion measured by ultrasonography.
Contact information is provided by the study sponsor or research team.
Mürsel Ekinci, MD
CONTACT
Yusuf Alan, MD
CONTACT
Ferit Yetik
Other Gov
Comparison of the Analgesic Efficacy and Effects on Diaphragmatic Function of Bilateral Erector Spinae Plane Block and Bilateral Rhomboid Intercostal-Subserratus Plane Block in Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial
Acronym: RISS-ESP-LC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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