Cholelithiasis, Postoperative Pain
Conditions
Keywords
Laparoscopic Cholecystectomy, Rectointercostal Plane Block, RICPB
Brief 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. 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.
Interventions
PROCEDURERectointercostal Plane Block
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.
Conventional port-site local anesthetic infiltration will be performed at the end of surgery according to the study protocol to provide postoperative analgesia.
Sponsors
Koç University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be unaware of group allocation. Postoperative assessments, including pain scores, opioid consumption, and postoperative complications, will be performed by an independent outcomes assessor who is blinded to treatment assignment. The anesthesiologist performing the intervention will not be blinded due to the nature of the procedure.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Postoperative Morphine Consumption | Postoperative 24 hours | Total morphine consumption administered via patient-controlled analgesia during the first 24 hours after surgery will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores | Postoperative 1, 3, 6, 12, and 24 hours | 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. |
| Rescue Analgesic Requirement | Postoperative 24 hours | 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. |
| Postoperative Complications | Postoperative 24 hours | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTErgun Mendes, MD
Outcome results
None listed