Ultrasound-Guided Regional Blocks for Postoperative Analgesia After Laparoscopic Cholecystectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstanbul Medipol University Hospital
About this trial
Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described abdominal wall block performed by injecting local anesthetic between the rectus abdominis muscle and the costal cartilage of the 7th rib. Due to the cranial attachment of the rectus muscle, this technique provides effective analgesia to the sternal, epigastric, and upper-mid abdominal regions, corresponding to the T6-T10/11 dermatomal levels. RIFPB may be used as an adjunct technique for thoracic procedures or as a standalone block for abdominal surgery.
Ultrasound-guided transversus abdominis plane block (TAPB) is performed by injecting local anesthetic into the fascial plane between the internal oblique and transversus abdominis muscles. TAPB provides sensory blockade of the anterolateral abdominal wall at the T6-L1 dermatomal levels and is widely used for postoperative analgesia following abdominal surgeries, including laparoscopic cholecystectomy.
This study aims to compare the effectiveness of US-guided RIFPB and TAPB on postoperative pain control after laparoscopic cholecystectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA physical status I-II
Scheduled for elective laparoscopic cholecystectomy
Disqualifiers
Known allergy to local anesthetics or opioid medications
Infection at the planned block site
History of alcohol or drug dependence
Use of anticoagulant therapy
Trial design
Design model
Parallel
Treatments tested in this trial
Recto-Intercostal Fascial Plane Block
Procedure/SurgeryThe block will be performed under general anesthesia immediately before extubation, with the patient in the supine position under ultrasound guidance (Vivid Q). After aseptic preparation, a high-frequency linear probe (11-12 MHz) covered with a sterile sheath and an 80-mm block needle (Braun 360°) will be used. The probe will be positioned to identify the xiphoid process, rectus abdominis muscle, and sixth costal cartilage. Using an in-plane technique, the needle will be advanced in a caudal-to-cephalic direction. After confirmation of correct needle placement with 5 mL saline, 20 mL of 0.25% bupivacaine (Buvacaine, Polifarma ®) will be injected on each side (total volume 40 mL).
Transversus- Abdominis Plane Block
Procedure/SurgeryThe transversus abdominis plane block will be performed immediately after completion of surgery and before extubation, with the patient in the supine position under ultrasound guidance( Vivid Q). Following aseptic preparation, a high-frequency linear probe (11-12 MHz) and an 80-mm block needle (Braun 360°) will be used to identify the abdominal wall muscle layers at the anterior axillary line between the 12th rib and the iliac crest. Using an in-plane technique, the needle will be advanced into the plane between the internal oblique and transversus abdominis muscles. After confirmation of correct needle placement with 5 ml saline injection, 20 mL of 0.25% bupivacaine (Buvacaine, Polifarma ®) will be administered to each side (total volume 40 mL).
Post-operative Pain Management
Other interventionThirty minutes before the end of surgery, all patients will receive the standard postoperative analgesia regimen consisting of intravenous ibuprofen 400 mg (Intrafen®) and intravenous tramadol 100 mg (Contramal®). Postoperative patient assessment will be performed by an anesthesiologist who is not involved in the intervention.If the patient's NRS score is ≥4 at any time point, intravenous meperidine (Aldolan®) at a dose of 0.5 mg/kg will be administered as rescue analgesia.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Recto-intercostal fascial plane blockActive comparator 2 interventions
Group B: Transversus abdominis plane blockActive comparator 2 interventions
Group C: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Opioid consumption
Total postoperative opioid consumption will be recorded for each patient during the first 24 hours after surgery. Opioid use will be quantified based on the total dose of rescue opioid analgesics administered and compared between study groups to assess differences in postoperative opioid requirements.
Time frame
During the first 24 hours postoperativelySecondary outcomes
1
Postoperative pain scores
Postoperative pain will be assessed using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain scores will be recorded both at rest and during ambulation at 1, 3, 6, 12, 18, and 24 hours postoperatively. NRS scores will be compared between study groups to evaluate differences in postoperative pain intensity.
Time frame
Postoperative hours 1, 3, 6, 12, 18, and 24.2
Adverse events
Adverse events (nausea, vomiting, itching, ect) related to opioid use will be recorded for each patient
Time frame
During the first 24 hours postoperatively3
Postoperative Rescue Analgesic Consumption:
The use of rescue analgesics in the postoperative period will be recorded and compared between study groups to evaluate differences in the need for additional analgesia.
Time frame
During the first 24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov