CholelithiasisRICPBNCT07676552
Rectointercostal Plane Block (RICPB) for Laparoscopic Cholecystectomy
A study testing Rectointercostal Plane Block and Port-Site Local Anesthetic Infiltration in people with Cholelithiasis and Postoperative Pain, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized controlled trial is designed to evaluate the analgesic efficacy of ultrasound-guided rectointercostal plane block (RICPB) in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomized to receive unilateral right-sided RICPB at the end of surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholelithiasis, Postoperative Pain
- What is being tested?
- Rectointercostal Plane Block and Port-Site Local Anesthetic Infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Feb 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective laparoscopic cholecystectomy
- Body mass index (BMI) between 18 and 35 kg/m²
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Refusal to participate or inability to provide informed consent
- Known allergy or hypersensitivity to local anesthetics, opioids, or study medications
- Chronic opioid use or chronic pain syndrome
- Coagulation disorders or ongoing anticoagulant therapy
- Infection at the planned injection site
- Pregnancy or breastfeeding
Show all 10Show fewer
- Cognitive impairment or inability to communicate pain scores
- Severe hepatic, renal, cardiac, or respiratory disease judged by the investigator to interfere with study participation
- Conversion from laparoscopic to open surgery
- Previous upper abdominal surgery that may interfere with the block technique or pain assessment
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
Koç University Hospital
Istanbul, Istanbul, 34010
Ergun Mendes, MD, +905514265012, emendes@kuh.ku.edu.tr
About this study
Official title: Rectointercostal Plane Block (RICPB) for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
This prospective randomized controlled trial is designed to evaluate the analgesic efficacy of ultrasound-guided rectointercostal plane block (RICPB) in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomized to receive unilateral right-sided RICPB at the end of surgery. Postoperative opioid consumption, Numeric Rating Scale (NRS) pain scores, and postoperative complications will be assessed to determine the effectiveness of RICPB in postoperative pain management.
Read the detailed description
Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures. Although it is considered a minimally invasive technique, patients frequently experience moderate postoperative pain resulting from trocar insertion sites, surgical manipulation, and irritation of the abdominal wall and peritoneum. Effective postoperative pain management is essential to facilitate early mobilization, improve patient comfort, reduce opioid consumption, and enhance recovery.
The rectointercostal plane block (RICPB) is an ultrasound-guided fascial plane block that has recently emerged as a potential analgesic technique for upper abdominal surgery. By depositing local anesthetic between the rectus abdominis muscle and the costal cartilages/intercostal muscles, RICPB may provide analgesia to the anterior upper abdominal wall. However, evidence regarding its effectiveness in laparoscopic cholecystectomy remains limited.
This single-center, prospective, randomized controlled trial is designed to evaluate the analgesic efficacy of ultrasound-guided rectointercostal plane block in patients undergoing elective laparoscopic cholecystectomy. Eligible patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be enrolled after providing written informed consent. Participants will be randomly allocated in a 1:1 ratio to either the RICPB group or the control group.
Patients assigned to the RICPB group will receive an ultrasound-guided unilateral right-sided rectointercostal plane block with 30 mL of 0.25% bupivacaine at the end of surgery before emergence from anesthesia. Patients in the control group will receive conventional port-site local anesthetic infiltration according to institutional practice. All patients will undergo a standardized general anesthesia protocol and receive the same multimodal postoperative analgesic regimen.
Postoperative pain assessments will be performed using the Numeric Rating Scale (NRS). Opioid consumption, pain scores and postoperative complications, including postoperative nausea and vomiting (PONV), will be recorded during the first 24 postoperative hours.
The primary outcome of the study is cumulative opioid consumption during the first 24 postoperative hours. Secondary outcomes include postoperative NRS pain scores, rescue analgesic requirements, and the incidence of postoperative complications. The study aims to determine whether ultrasound-guided rectointercostal plane block provides superior postoperative analgesia compared with conventional port-site local anesthetic infiltration in patients undergoing laparoscopic cholecystectomy.
- Conditions
- Cholelithiasis, Postoperative Pain
- Being tested
- Rectointercostal Plane Block, Port-Site Local Anesthetic Infiltration
- Keywords
- Laparoscopic Cholecystectomy, Rectointercostal Plane Block, RICPB
- Medical subject headings
- Cholelithiasis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectointercostal Plane BlockProcedure or surgery
Also called RICPB
Ultrasound-guided unilateral right-sided rectointercostal plane block (RICPB) will be performed at the end of surgery before emergence from anesthesia. A total of 30 mL of 0.25% bupivacaine will be injected into the rectointercostal plane under ultrasound guidance.
Port-Site Local Anesthetic InfiltrationProcedure or surgery
Conventional port-site local anesthetic infiltration will be performed at the end of surgery according to the study protocol to provide postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| RICPB Group | Experimental | Participants will receive an ultrasound-guided unilateral right-sided rectointercostal plane block (RICPB) with 30 mL of 0.25% bupivacaine at the end of surgery before emergence from anesthesia. Receives: Procedure: Rectointercostal Plane Block |
| Port-Site Infiltration Group | Active comparator | Participants will receive conventional port-site local anesthetic infiltration at the end of surgery according to the study protocol. Receives: Procedure: Port-Site Local Anesthetic Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Postoperative Morphine Consumption
Total morphine consumption administered via patient-controlled analgesia during the first 24 hours after surgery will be recorded.
Measured: Postoperative 24 hours
Secondary outcomes (3)
Postoperative Pain Scores
Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10) at predefined postoperative time points. NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
Measured: Postoperative 1, 3, 6, 12, and 24 hours
Rescue Analgesic Requirement
The requirement for rescue analgesia during the first 24 postoperative hours will be recorded. Rescue analgesia will be administered according to the study protocol when the NRS pain score is 4 or higher.
Measured: Postoperative 24 hours
Postoperative Complications
The incidence of postoperative complications, including postoperative nausea and vomiting (PONV), pruritus, respiratory complications, and other adverse events occurring during the postoperative period, will be recorded.
Measured: 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 posted30 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies 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
- Eligible participants will be randomized in a 1:1 ratio to receive either ultrasound-guided rectointercostal plane block (RICPB) or conventional port-site local anesthetic infiltration following laparoscopic cholecystectomy.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ergün Mendes, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676552
- Sponsor's protocol ID
- 2025.387.IRB1.061
- Acronym
- RICPB
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mendes E, Gokkaya Z, Halis A, Uymaz DS, Gurkan Y. Rectointercostal plane block for postoperative analgesia in preperitoneal enhanced-view totally extraperitoneal umbilical hernia repair: a new indication area. Minerva Anestesiol. 2026 Jun;92(6):635-637. doi: 10.23736/S0375-9393.25.19781-2. Epub 2026 Jan 27. No abstract available.
PubMed 41591374Mendes E, Yaylak D, Sincer Y, Uymaz DS, Gurkan Y. Rectointercostal Fascial Plane Block as a Practical Option for Somatic Analgesia in Gastric Bypass Surgery: A Case Report. A A Pract. 2025 Nov 10;19(11):e02100. doi: 10.1213/XAA.0000000000002100. eCollection 2025 Nov 1.
PubMed 41212719Ciftci B, Ahiskalioglu A, Tulgar S. The recto-intercostal fascial plane block: An anatomically grounded solution for upper abdominal analgesia. Indian J Anaesth. 2026 Apr;70(4):601-603. doi: 10.4103/ija.ija_1248_25. Epub 2026 Apr 20. No abstract available.
PubMed 42145288Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.
PubMed 37295124
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectointercostal Plane Block (RICPB) for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07676552
- Acronym / sponsor ID
- RICPB / 2025.387.IRB1.061
- Conditions
- Cholelithiasis, Postoperative Pain
- Keywords
- Laparoscopic Cholecystectomy, Rectointercostal Plane Block, RICPB
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 30 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 is designed to evaluate the analgesic efficacy of ultrasound-guided rectointercostal plane block (RICPB) in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomized to receive unilateral right-sided RICPB at the end of surgery. Postoperative opioid consumption, Numeric Rating Scale (NRS) pain scores, and postoperative complications will be assessed to determine the effectiveness of RICPB in postoperative pain management.
Detailed description
Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures. Although it is considered a minimally invasive technique, patients frequently experience moderate postoperative pain resulting from trocar insertion sites, surgical manipulation, and irritation of the abdominal wall and peritoneum. Effective postoperative pain management is essential to facilitate early mobilization, improve patient comfort, reduce opioid consumption, and enhance recovery.
The rectointercostal plane block (RICPB) is an ultrasound-guided fascial plane block that has recently emerged as a potential analgesic technique for upper abdominal surgery. By depositing local anesthetic between the rectus abdominis muscle and the costal cartilages/intercostal muscles, RICPB may provide analgesia to the anterior upper abdominal wall. However, evidence regarding its effectiveness in laparoscopic cholecystectomy remains limited.
This single-center, prospective, randomized controlled trial is designed to evaluate the analgesic efficacy of ultrasound-guided rectointercostal plane block in patients undergoing elective laparoscopic cholecystectomy. Eligible patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be enrolled after providing written informed consent. Participants will be randomly allocated in a 1:1 ratio to either the RICPB group or the control group.
Patients assigned to the RICPB group will receive an ultrasound-guided unilateral right-sided rectointercostal plane block with 30 mL of 0.25% bupivacaine at the end of surgery before emergence from anesthesia. Patients in the control group will receive conventional port-site local anesthetic infiltration according to institutional practice. All patients will undergo a standardized general anesthesia protocol and receive the same multimodal postoperative analgesic regimen.
Postoperative pain assessments will be performed using the Numeric Rating Scale (NRS). Opioid consumption, pain scores and postoperative complications, including postoperative nausea and vomiting (PONV), will be recorded during the first 24 postoperative hours.
The primary outcome of the study is cumulative opioid consumption during the first 24 postoperative hours. Secondary outcomes include postoperative NRS pain scores, rescue analgesic requirements, and the incidence of postoperative complications. The study aims to determine whether ultrasound-guided rectointercostal plane block provides superior postoperative analgesia compared with conventional port-site local anesthetic infiltration in patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized in a 1:1 ratio to receive either ultrasound-guided rectointercostal plane block (RICPB) or conventional port-site local anesthetic infiltration following laparoscopic cholecystectomy.
| Arm | Type | Receives |
|---|---|---|
| RICPB Group | Experimental | Procedure: Rectointercostal Plane BlockParticipants will receive an ultrasound-guided unilateral right-sided rectointercostal plane block (RICPB) with 30 mL of 0.25% bupivacaine at the end of surgery before emergence from anesthesia. |
| Port-Site Infiltration Group | Active comparator | Procedure: Port-Site Local Anesthetic InfiltrationParticipants will receive conventional port-site local anesthetic infiltration at the end of surgery according to the study protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective laparoscopic cholecystectomy
- Body mass index (BMI) between 18 and 35 kg/m²
- Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (10 listed)
- Refusal to participate or inability to provide informed consent
- Known allergy or hypersensitivity to local anesthetics, opioids, or study medications
- Chronic opioid use or chronic pain syndrome
- Coagulation disorders or ongoing anticoagulant therapy
- Infection at the planned injection site
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 |
|---|---|---|
| Rectointercostal Plane BlockAlso: RICPBUltrasound-guided unilateral right-sided rectointercostal plane block (RICPB) will be performed at the end of surgery before emergence from anesthesia. A total of 30 mL of 0.25% bupivacaine will be injected into the rectointercostal plane under ultrasound guidance. | Procedure or surgery | RICPB Group |
| Port-Site Local Anesthetic InfiltrationConventional port-site local anesthetic infiltration will be performed at the end of surgery according to the study protocol to provide postoperative analgesia. | Procedure or surgery | Port-Site Infiltration Group |
Primary outcome
Cumulative Postoperative Morphine Consumption
Time frame: Postoperative 24 hours
Total morphine consumption administered via patient-controlled analgesia during the first 24 hours after surgery will be recorded.
3 secondary outcomes
Postoperative Pain Scores
Time frame: Postoperative 1, 3, 6, 12, and 24 hours
Rescue Analgesic Requirement
Time frame: Postoperative 24 hours
Postoperative Complications
Time frame: 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 2 Jul 2026.
- Background: PubMed 41591374Mendes E, Gokkaya Z, Halis A, Uymaz DS, Gurkan Y. Rectointercostal plane block for postoperative analgesia in preperitoneal enhanced-view totally extraperitoneal umbilical hernia repair: a new indication area. Minerva Anestesiol. 2026 Jun;92(6):635-637. doi: 10.23736/S0375-9393.25.19781-2. Epub 2026 Jan 27. No abstract available.
- Background: PubMed 41212719Mendes E, Yaylak D, Sincer Y, Uymaz DS, Gurkan Y. Rectointercostal Fascial Plane Block as a Practical Option for Somatic Analgesia in Gastric Bypass Surgery: A Case Report. A A Pract. 2025 Nov 10;19(11):e02100. doi: 10.1213/XAA.0000000000002100. eCollection 2025 Nov 1.
- Background: PubMed 42145288Ciftci B, Ahiskalioglu A, Tulgar S. The recto-intercostal fascial plane block: An anatomically grounded solution for upper abdominal analgesia. Indian J Anaesth. 2026 Apr;70(4):601-603. doi: 10.4103/ija.ija_1248_25. Epub 2026 Apr 20. No abstract available.
- Background: PubMed 37295124Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectointercostal Plane Block and Port-Site Local Anesthetic Infiltration in people with Cholelithiasis and Postoperative Pain, run by Koç University 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 2 Jul 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 Ergun Mendes, MD (+905514265012, emendes@kuh.ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Postoperative Morphine Consumption (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07676552, which also lists 4 linked publications.
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 2 Jul 2026.