RCT: Multi-modal Analgesia for Laparoscopic Cholecystectomy (LapChole)
Gallstones, Cholelithiasis, Pain
About this trial
This is an interventional treatment trial for Gallstones focused on measuring gallstones, cholelithiasis, cholecystectomy, laparoscopic, pain
Eligibility Criteria
Inclusion Criteria:
- symptomatic cholelithiasis undergo elective laparoscopic cholecystectomy
- non - pregnant women
- 18 years or older
Exclusion Criteria:
- undergoing urgent cholecystectomy
- patients operated on for indications other than symptomatic cholelithiasisT
- those having conversion from laparoscopic to open cholecystectomy
- those that withdrew from the study for any reason before the end of the required 7-day follow up (including those that died during that period)
- those with incomplete data.
Sites / Locations
- Klinicki Centar Vojvodine
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Multi-modal analgesia
Control
Thirty-one patients were enrolled in this arm. Standard analgesia according to institutional standard and 50:50 mixture of normal saline (8 ml) and 0.5% Bupivacaine was prepared within a 20 ml syringe (Total volume = 16 ml; Final concentration = 0.25%). Following delivery of the gallbladder specimen 8 ml of 0.25% bupivacaine solution was sprayed onto the cystic plate (gallbladder fossa) with a spinal needle advanced under direct laparoscopic vision via a 5mm right subcostal laparoscopic port. The anesthetic solution was sprayed at an operating distance from the cystic plate of ~ 2 cm. Following evacuation of the pneumoperitoneum, the remaining 8 ml of 0.25% Bupivacaine was infiltrated subcutaneously at each of the 4 laparoscopic port sites (2 ml per port site) prior sutured closure.
Thirty-two patients were enrolled in this arm. They received standard analgesia according to institutional standard of practice consisted of non-narcotic analgesia with narcotic analgesic rescue after laparoscopic cholecystectomy.