Acute Pain, Laparoscopic Cholecystectomy, Pain Management, Plane Blocks
Conditions
Keywords
Laparoscopic cholecystectomy, Postoperative analgesia, Recto-intercostal fascial plane block, Transversus abdominis plane block, Regional anesthesia, Opioid consumption
Brief summary
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.
Detailed description
Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures. Postoperative pain after laparoscopic cholecystectomy is multifactorial and may result from trocar site incisions, visceral manipulation, peritoneal irritation, and diaphragmatic stimulation due to pneumoperitoneum. Various analgesic strategies, including systemic opioids, non-opioid analgesics, local anesthetic infiltration, and regional anesthesia techniques, are used to manage postoperative pain in these patients. Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described regional anesthesia technique that provides analgesia to the sternal, epigastric, and upper-mid abdominal regions by targeting the fascial plane between the rectus abdominis muscle and the costal cartilage. RIFPB provides sensory blockade at the T6-T10/11 dermatomal levels and has been reported to be effective for postoperative analgesia in thoracic and upper abdominal procedures. Due to its anatomical spread and mechanism of action, RIFPB may offer effective analgesia following laparoscopic cholecystectomy. Ultrasound-guided transversus abdominis plane block (TAPB) is a well-established regional anesthesia technique performed by injecting local anesthetic between the internal oblique and transversus abdominis muscles. TAPB provides analgesia to the anterolateral abdominal wall at the T6-L1 dermatomal levels and is commonly used for postoperative pain control after various abdominal surgeries, including laparoscopic cholecystectomy. In this study, the investigators aim to compare the effectiveness of US-guided RIFPB and TAPB for postoperative pain management after laparoscopic cholecystectomy and to compare both techniques with a control group.
Interventions
The 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).
PROCEDURETransversus- Abdominis Plane Block
The 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).
OTHERPost-operative Pain Management
Thirty 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.
Sponsors
Istanbul Medipol University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcomes assessor and participants will be blinded to the study
Intervention model description
Ninety patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled to undergo laparoscopic cholecystectomy will be included in the study. Patients will be randomly assigned to three groups before entering the operating room: the recto-intercostal fascial plane block group (Group RIFPB), the transversus abdominis plane block group (Group TAPB), and the control group, with 30 patients in each group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status I-II * Scheduled for elective laparoscopic cholecystectomy
Exclusion criteria
* Known allergy to local anesthetics or opioid medications * Infection at the planned block site * History of alcohol or drug dependence * Use of anticoagulant therapy * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | During the first 24 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain scores | Postoperative hours 1, 3, 6, 12, 18, and 24. | 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. |
| Adverse events | During the first 24 hours postoperatively | Adverse events (nausea, vomiting, itching, ect) related to opioid use will be recorded for each patient |
| Postoperative Rescue Analgesic Consumption: | During the first 24 hours postoperatively | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed