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Rectointercostal Plane Block (RICPB) for Laparoscopic Cholecystectomy

ConditionsCholelithiasisPostoperative Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKoç University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rectointercostal Plane Block

    Procedure/Surgery

    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 Infiltration

    Procedure/Surgery

    Conventional port-site local anesthetic infiltration will be performed at the end of surgery according to the study protocol to provide postoperative analgesia.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: RICPB GroupExperimental treatment 1 intervention
Group B: Port-Site Infiltration GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Koç University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: