Menu
Recruiting NCT07655323

RISS Versus ESP Block in Laparoscopic Cholecystectomy

No phase Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erector Spinae Plane Block, Rhomboid Intercostal-Subserratus Plane Block.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Procedure Erector Spinae Plane Block
    Bilateral ultrasound-guided erector spinae plane block performed 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.

Primary outcome measures

  • Total Postoperative Tramadol Consumption [Time frame: 24 hours after surgery]
Secondary outcome measures (6)
  • Postoperative Pain Scores [Time frame: 0-24 hours after surgery]
  • Time to First Rescue Analgesia [Time frame: 24 hours after surgery]
  • Intraoperative Remifentanil Consumption [Time frame: During surgery]
  • Opioid-Related Adverse Events [Time frame: 24 hours after surgery]
  • Block-Related Complications [Time frame: 24 hours after surgery]
  • Diaphragmatic Excursion [Time frame: Preoperative and postoperative 24 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Bursa City Hospital — Bursa

Identifiers

NCT: NCT07655323 · 26-AKD-134

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗