An interventional study of Rectointercostal Plane Block and Port-Site Local Anesthetic Infiltration in Cholelithiasis and Postoperative Pain, sponsored by Koç University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Koç University · Not applicable, Interventional, and Treatment
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.
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.
189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 135 interventional studies indexed under Cholelithiasis.
Browse Cholelithiasis studies →Koç University is the lead sponsor of 109 studies on the registry; 36 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Rectointercostal Plane Block
Participants will receive conventional port-site local anesthetic infiltration at the end of surgery according to the study protocol.
Procedure: Port-Site Local Anesthetic Infiltration
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.
Also known as: RICPB
Conventional port-site local anesthetic infiltration will be performed at the end of surgery according to the study protocol to provide postoperative analgesia.
Cumulative Postoperative Morphine Consumption
Total morphine consumption administered via patient-controlled analgesia during the first 24 hours after surgery will be recorded.
Time frame: Postoperative 24 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: Postoperative 24 hours
Plan to share: No
Start is estimated for Jul 2026; primary completion for Jan 2027, 6 months later.
Of 54 non-industry interventional studies with no phase under Cholelithiasis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 6 months is below that.
Counting every sponsor, half of 58 studies reached it within 15 months; a quarter within 6 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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