Pain Management, Recto Intercostal Nerve Block
Conditions
Keywords
cholecystektomy, rectointercostal facial plane block, opioid consumption, postoperative pain
Brief summary
This study aims to evaluate whether an ultrasound-guided recto-intercostal fascial plane block performed before surgical incision in patients undergoing laparoscopic cholecystectomy reduces intraoperative opioid and volatile anesthetic consumption. Additionally, the study assesses its effects on postoperative pain and the incidence of nausea and vomiting.
Detailed description
This prospective, randomized controlled trial is conducted at Etlik City Hospital and includes adult patients undergoing elective laparoscopic cholecystectomy. Institutional Ethics Committee approval is obtained, and the study is conducted in accordance with the Declaration of Helsinki. Participants are randomly assigned into two groups using a closed-envelope method. All patients receive general anesthesia. After induction and intubation, the block group receives an ultrasound-guided recto-intercostal fascial plane block prior to surgical incision, while the control group receives standard analgesic management. Anesthesia is maintained at approximately 1 minimum alveolar concentration (MAC) with bispectral index (BIS) values between 40 and 60. The primary outcome is intraoperative opioid and volatile anesthetic consumption. Secondary outcomes include intraoperative hemodynamic parameters, postoperative pain intensity assessed using the Numerical Rating Scale (NRS), and the incidence of postoperative nausea and vomiting (PONV). The recto-intercostal fascial plane block is performed under ultrasound guidance by an experienced anesthesiologist under aseptic conditions. Local anesthetic is administered bilaterally into the fascial plane between the rectus muscle and the costal cartilage.
Interventions
PROCEDUREProcedure: Recto-intercostal fascial plane block
A total of 30 mL of 0.25% bupivacaine is administered bilaterally under ultrasound guidance into the recto-intercostal fascial plane prior to surgical incision.
Sponsors
Ankara Etlik City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The block procedure is performed after induction of general anesthesia, and participants are unaware of group allocation. Postoperative outcome assessment is conducted by an investigator who is blinded to group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 18-65 years * Scheduled for elective laparoscopic cholecystectomy * American Society of Anesthesiologists (ASA) physical status I-III * Ability to provide written informed consent
Exclusion criteria
* Refusal to participate * Known allergy to local anesthetics * Coagulopathy or anticoagulant therapy * Infection at the injection site * Body weight less than 75 kg * Severe hepatic or renal dysfunction * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative volatile anesthetic consumption | During surgery (up to 3 hours) | Total intraoperative volatile anesthetic consumption per patient, measured in milliliters (mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative opioid consumption | During surgery (up to 3 hours) | Total amount of opioids administered intraoperatively, measured in micrograms (mcg) per patient. |
Countries
Turkey (Türkiye)
Outcome results
None listed