Postoperative PainRISS-ESP-LCNCT07655323
RISS Versus ESP Block in Laparoscopic Cholecystectomy
A study testing Erector Spinae Plane Block and Rhomboid Intercostal-Subserratus Plane Block in people with Postoperative Pain, run by Ferit Yetik at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector Spinae Plane Block and Rhomboid Intercostal-Subserratus Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- ASA physical status I-III
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Provision of written informed consent
Who cannot join
- Coagulation disorders or anticoagulant therapy
- Known allergy to local anesthetics
- Infection at the block application site
- Pregnancy or lactation
- Chronic opioid use
- Cognitive impairment
Show all 9Show fewer
- Refusal to participate in the study
- Technical inability to perform the block
- Failed block
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa City Hospital
Bursa, Nilüfer, 16100
Yusuf Alan, MD, 05396210977, dryusufalan@gmail.com
drmurselekinci@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Erector Spinae Plane Block, Rhomboid Intercostal-Subserratus Plane Block
- Keywords
- Laparoscopic Cholecystectomy, Erector Spinae Plane Block, Rhomboid Intercostal Subserratus Plane Block, Regional Anesthesia, Diaphragmatic Function, Postoperative Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Bilateral ultrasound-guided erector spinae plane block performed before laparoscopic cholecystectomy for postoperative analgesia.
Rhomboid Intercostal-Subserratus Plane BlockProcedure or surgery
Bilateral ultrasound-guided rhomboid intercostal-subserratus plane block performed before laparoscopic cholecystectomy for postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| ESP Block | Experimental | Patients will receive bilateral ultrasound-guided erector spinae plane block before laparoscopic cholecystectomy for postoperative analgesia. Receives: 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. Receives: Procedure: Rhomboid Intercostal-Subserratus Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Postoperative Tramadol Consumption
Total tramadol consumption during the first 24 hours after laparoscopic cholecystectomy.
Measured: 24 hours after surgery
Secondary outcomes (6)
Postoperative Pain Scores
Postoperative pain scores assessed using the Numeric Rating Scale (NRS).
Measured: 0-24 hours after surgery
Time to First Rescue Analgesia
Time from the end of surgery to first rescue analgesic requirement.
Measured: 24 hours after surgery
Intraoperative Remifentanil Consumption
Total remifentanil consumption during surgery.
Measured: During surgery
Opioid-Related Adverse Events
Incidence of nausea, vomiting, pruritus and other opioid-related adverse events.
Measured: 24 hours after surgery
Block-Related Complications
Complications associated with ESP block or RISS block.
Measured: 24 hours after surgery
Diaphragmatic Excursion
Right hemidiaphragm excursion measured by ultrasonography.
Measured: Preoperative and postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start18 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ferit Yetik
- Sponsor type
- Other government
- Collaborators
- Bursa City Hospital
- Responsible party
- Sponsor-investigator, Ferit Yetik, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Mürsel Ekinci, MD, Principal investigator, Bursa City Hospital, Health Sciences University Bursa Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655323
- Sponsor's protocol ID
- 26-AKD-134
- Acronym
- RISS-ESP-LC
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07655323
- Acronym / sponsor ID
- RISS-ESP-LC / 26-AKD-134
- Conditions
- Postoperative Pain
- Keywords
- Laparoscopic Cholecystectomy, Erector Spinae Plane Block, Rhomboid Intercostal Subserratus Plane Block, Regional Anesthesia, Diaphragmatic Function, Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ferit YetikOther government
- Collaborators
- Bursa City Hospital
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ESP Block | Experimental | Procedure: Erector Spinae Plane BlockPatients will receive bilateral ultrasound-guided erector spinae plane block before laparoscopic cholecystectomy for postoperative analgesia. |
| RISS Block | Experimental | Procedure: Rhomboid Intercostal-Subserratus Plane BlockPatients will receive bilateral ultrasound-guided rhomboid intercostal-subserratus plane block before laparoscopic cholecystectomy for postoperative analgesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 75 years
- ASA physical status I-III
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Provision of written informed consent
Key exclusion criteria (9 listed)
- Coagulation disorders or anticoagulant therapy
- Known allergy to local anesthetics
- Infection at the block application site
- Pregnancy or lactation
- Chronic opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockBilateral ultrasound-guided erector spinae plane block performed before laparoscopic cholecystectomy for postoperative analgesia. | Procedure or surgery | ESP Block |
| Rhomboid Intercostal-Subserratus Plane BlockBilateral ultrasound-guided rhomboid intercostal-subserratus plane block performed before laparoscopic cholecystectomy for postoperative analgesia. | Procedure or surgery | RISS Block |
Primary outcome
Total Postoperative Tramadol Consumption
Time frame: 24 hours after surgery
Total tramadol consumption during the first 24 hours after laparoscopic cholecystectomy.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mürsel Ekinci, MD principal investigator
Bursa City Hospital, Health Sciences University Bursa Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and Rhomboid Intercostal-Subserratus Plane Block in people with Postoperative Pain, run by Ferit Yetik at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mürsel Ekinci, MD (+905067137596, drmurselekinci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Postoperative Tramadol Consumption (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.