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NCT Number: NCT07655323

RISS Versus ESP Block in Laparoscopic Cholecystectomy

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa City Hospital

Bursa, Nilüfer, 16100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mürsel Ekinci, MD

PRINCIPAL_INVESTIGATOR

Yusuf Alan, MD

CONTACT

[email protected]

05396210977

Yusuf Alan, MD

SUB_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector Spinae Plane Block

Procedure

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

Rhomboid Intercostal-Subserratus Plane Block

Procedure

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

Primary outcomes

  1. Total Postoperative Tramadol Consumption

    Time frame: 24 hours after surgery

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

Secondary outcomes

  1. Postoperative Pain Scores

    Time frame: 0-24 hours after surgery

    Postoperative pain scores assessed using the Numeric Rating Scale (NRS).

  2. Time to First Rescue Analgesia

    Time frame: 24 hours after surgery

    Time from the end of surgery to first rescue analgesic requirement.

  3. Intraoperative Remifentanil Consumption

    Time frame: During surgery

    Total remifentanil consumption during surgery.

  4. Opioid-Related Adverse Events

    Time frame: 24 hours after surgery

    Incidence of nausea, vomiting, pruritus and other opioid-related adverse events.

  5. Block-Related Complications

    Time frame: 24 hours after surgery

    Complications associated with ESP block or RISS block.

  6. Diaphragmatic Excursion

    Time frame: Preoperative and postoperative 24 hours

    Right hemidiaphragm excursion measured by ultrasonography.

Study contacts

Contact information is provided by the study sponsor or research team.

Mürsel Ekinci, MD

CONTACT

[email protected]

+905067137596

Yusuf Alan, MD

CONTACT

[email protected]

+905396210977

Sponsors and collaborators

Lead sponsor

Ferit Yetik

Other Gov

Collaborators

  • Bursa City Hospital

Registry information

Official study 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

Acronym: RISS-ESP-LC

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jun 22, 2026

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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