RISS Versus ESP Block in Laparoscopic Cholecystectomy

NCT07655323 | Not Yet Recruiting

• 1 other identifier: 26-AKD-134
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Laparoscopic Cholecystectomy; Erector Spinae Plane Block; Rhomboid Intercostal Subserratus Plane Block; Regional Anesthesia; Diaphragmatic Function; Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• Total Postoperative Tramadol Consumption

  Total tramadol consumption during the first 24 hours after laparoscopic cholecystectomy.

  24 hours after surgery

Secondary Outcomes (6)

• Postoperative Pain Scores

  0-24 hours after surgery

• Time to First Rescue Analgesia

  24 hours after surgery

• Intraoperative Remifentanil Consumption

  During surgery

• Opioid-Related Adverse Events

  24 hours after surgery

• Block-Related Complications

  24 hours after surgery

Study Arms (2)

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

Erector Spinae Plane Block PROCEDURE

Bilateral ultrasound-guided erector spinae plane block performed before laparoscopic cholecystectomy for postoperative analgesia.

ESP Block

Rhomboid Intercostal-Subserratus Plane Block PROCEDURE

Bilateral ultrasound-guided rhomboid intercostal-subserratus plane block performed before laparoscopic cholecystectomy for postoperative analgesia.

RISS Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferit Yetik: lead
• Bursa City Hospital: collaborator

Study Sites (1)

Bursa City Hospital

Bursa, Nilüfer, 16100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mürsel Ekinci, MD

  Bursa City Hospital, Health Sciences University Bursa Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mürsel Ekinci, MD

CONTACT

+905067137596; drmurselekinci@gmail.com

Yusuf Alan, MD

CONTACT

+905396210977; dryusufalan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group allocation. Regional blocks will be performed by an anesthesiologist not involved in postoperative assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD.

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

TU (1)