Cholecystectomy, Laparoscopic, Postoperative Pain
Conditions
Keywords
External Oblique Intercostal Plane Block, Recto-Intercostal Fascial Plane Block, Fascial Plane Block, Regional Anesthesia, Postoperative Analgesia, Multimodal Analgesia
Brief summary
Laparoscopic cholecystectomy is a common surgical procedure that can cause significant postoperative pain, particularly originating from trocar insertion sites. Regional anesthesia techniques are frequently used as part of multimodal analgesia to improve patient comfort. This randomized controlled trial aims to evaluate the efficacy of adding a recto-intercostal fascial plane block (RIFPB) to an external oblique intercostal plane block (EOIPB). Patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned to receive either an EOIPB alone or a combination of EOIPB and RIFPB. The primary objective is to determine if the combined block approach provides superior postoperative analgesia, evaluated by compared to the EOIPB alone.
Interventions
PROCEDUREGroup EOIPB (External Oblique Intercostal Plane Block)
Patients will undergo bilateral EOIPB procedure using 20 ml of 0.20% bupivacaine on each side under ultrasound guidance.
PROCEDUREGroup EOIPB + RIFPB (Combined Blocks)
Patients will undergo bilateral EOIPB and RIFPB procedures under ultrasound guidance using 20 ml of 0.20% bupivacaine for the EOIPB block and 15 ml of 0.20% bupivacaine for the RIFPB on each side.
Sponsors
Ankara Etlik City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 75 years * American Society of Anesthesiologists (ASA) physical status I, II, or III * Patients scheduled for elective laparoscopic cholecystectomy
Exclusion criteria
* Known allergy to local anesthetics * Infection at the procedure/injection site * Severe coagulopathy or use of anticoagulants * Chronic opioid consumption or history of neuropathic pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | 4 hours after surgery | Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest. Pain assessment at rest will be made at 4 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | Up to 24 hours | Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest. Pain assessment at rest will be made at 1, 8, 12, and 24 hours after surgery. |
| Total Postoperative Opioid Consumption | Up to 24 hours | The total amount of opioid consumed by the patient will be recorded. |
| Severity of Postoperative Nausea and Vomiting (PONV) | Up to 24 hours | The severity of postoperative nausea will be assessed using an 11-point numerical rating scale (NRS), ranging from 0 to 10, where 0 indicates no nausea and 10 indicates the worst possible nausea. Vomiting will be recorded as the number of vomiting episodes. Nausea severity will be assessed at 1, 4, 8, 12, and 24 hours after surgery. Higher NRS scores indicate greater nausea severity. |
Countries
Turkey (Türkiye)
Contacts
CONTACTİbrahim MD Topcu
CONTACTMusa Ass. Prof Zengin
Outcome results
None listed