RISS Versus ESP Block in Laparoscopic Cholecystectomy (RISS-ESP-LC)

June 12, 2026 updated by: Ferit Yetik

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:-

  • Age between 18 and 75 years
  • ASA physical status I-III
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • Provision of written informed consent

Exclusion Criteria:

  • Coagulation disorders or anticoagulant therapy
  • Known allergy to local anesthetics
  • Infection at the block application site
  • Pregnancy or lactation
  • Chronic opioid use
  • Cognitive impairment
  • Refusal to participate in the study
  • Technical inability to perform the block
  • Failed block

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESP Block
Patients will receive bilateral ultrasound-guided erector spinae plane block before laparoscopic cholecystectomy for postoperative analgesia.
Procedure: Erector Spinae Plane Block
Bilateral ultrasound-guided erector spinae plane block performed before laparoscopic cholecystectomy for postoperative analgesia.
Experimental: RISS Block
Patients will receive bilateral ultrasound-guided rhomboid intercostal-subserratus plane block before laparoscopic cholecystectomy for postoperative analgesia.
Procedure: Rhomboid Intercostal-Subserratus Plane Block
Bilateral ultrasound-guided rhomboid intercostal-subserratus plane block performed before laparoscopic cholecystectomy for postoperative analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Postoperative Tramadol Consumption
Time Frame: 24 hours after surgery
Total tramadol consumption during the first 24 hours after laparoscopic cholecystectomy.
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Scores
Time Frame: 0-24 hours after surgery
Postoperative pain scores assessed using the Numeric Rating Scale (NRS).
0-24 hours after surgery
Time to First Rescue Analgesia
Time Frame: 24 hours after surgery
Time from the end of surgery to first rescue analgesic requirement.
24 hours after surgery
Intraoperative Remifentanil Consumption
Time Frame: During surgery
Total remifentanil consumption during surgery.
During surgery
Opioid-Related Adverse Events
Time Frame: 24 hours after surgery
Incidence of nausea, vomiting, pruritus and other opioid-related adverse events.
24 hours after surgery
Block-Related Complications
Time Frame: 24 hours after surgery
Complications associated with ESP block or RISS block.
24 hours after surgery
Diaphragmatic Excursion
Time Frame: Preoperative and postoperative 24 hours
Right hemidiaphragm excursion measured by ultrasonography.
Preoperative and postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferit Yetik

Collaborators

Bursa City Hospital

Investigators

  • Principal Investigator: Mürsel Ekinci, MD, Bursa City Hospital, Health Sciences University Bursa Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-AKD-134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data (IPD) sharing has not yet been determined. A final decision regarding data sharing will be made after study completion and in accordance with institutional policies and participant confidentiality requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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