RISS Versus ESP Block in Laparoscopic Cholecystectomy | NCT07655323

Studies
RISS Versus ESP Block in Laparoscopic Cholecystectomy

NCT07655323

Sponsor

Ferit Yetik

Status

Recruiting

Last Update Posted

Jun 22, 2026Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Erector Spinae Plane Block
Rhomboid Intercostal-Subserratus Plane Block

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

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

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2026Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Jun 12, 2026

First Submission Date that Met QC Criteria

Jun 12, 2026

First Posted Date

Jun 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2026

Last Update Posted Date

Jun 22, 2026Actual

Name	Class
Bursa City Hospital	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESP Block	Experimental	Patients will receive bilateral ultrasound-guided erector spinae plane block before laparoscopic cholecystectomy for postoperative analgesia.	Procedure: Erector Spinae Plane Block
RISS Block	Experimental	Patients will receive bilateral ultrasound-guided rhomboid intercostal-subserratus plane block before laparoscopic cholecystectomy for postoperative analgesia.	Procedure: Rhomboid Intercostal-Subserratus Plane Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erector Spinae Plane Block	Procedure	Bilateral ultrasound-guided erector spinae plane block performed before laparoscopic cholecystectomy for postoperative analgesia.	ESP Block

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Postoperative Pain Scores	Postoperative pain scores assessed using the Numeric Rating Scale (NRS).	0-24 hours after surgery
Time to First Rescue Analgesia	Time from the end of surgery to first rescue analgesic requirement.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mürsel Ekinci, MD	Contact	+905067137596		drmurselekinci@gmail.com
Yusuf Alan, MD	Contact	+905396210977		dryusufalan@gmail.com

Overall Officials

Name	Affiliation	Role
Mürsel Ekinci, MD	Bursa City Hospital, Health Sciences University Bursa Faculty of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bursa City Hospital	Recruiting	Bursa	Nilüfer	16100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Participants will be randomized in a 1:1 ratio to receive either bilateral erector spinae plane block (ESP) or bilateral rhomboid intercostal-subserratus plane block (RISS) before elective laparoscopic cholecystectomy. Outcomes will be compared between two parallel groups.

Masking Info

Masking

Double

Masking Description

Participants and outcome assessors will be blinded to group allocation. Regional blocks will be performed by an anesthesiologist not involved in postoperative assessments.

Who Masked

ParticipantOutcomes Assessor