Prospective randomized controlled trial comparing standard analgesia with combined intra-operative cystic plate and port-site local anesthesia for post-operative pain management in elective laparoscopic cholecystectomy.
Various mechanisms, including somatic and visceral nociceptive stimulation, have been suggested as a cause for pain after laparoscopic cholecystectomy (LC). We therefore conducted a prospective randomized controlled trial (PRCT) to evaluate whether somatovisceral pain blockade reduces pain after LC.



Analgesic efficacy of multimodal analgesia is superior to standard analgesia for patients undergoing elective LC for symptomatic cholelithiasis. Specifically, topical cystic plate and port-site injection with 0.25 % bupivacaine significantly reduces pain after LC.



This study was designed as single-blinded PRCT.



This study was conducted in an academic medical center.



Between February and May 2010 we randomly assigned 63 patients with symptomatic cholelithiasis in a 1:1 ratio to non-opioid/opioid analgesic combinations (Control Group, n = 32) and non-opioid/opioid analgesic combinations plus topical 0.25 % bupivacaine onto the cystic plate and local 0.25 % bupivacaine port-site injection, post-LC (Study Group, n = 31). Primary endpoint was patient-reported pain 1, 4, 6, 12, 24 h and 1 week post-LC using the Visual Analog Scale (VAS 0-10).



Study groups were comparable clinicopathologically. There were no adverse events. A statistically significant reduction in mean pain score was apparent in Study Group patients in comparison with Control Group (mean VAS 4.83 ± 2.33 vs. 6.80 ± 1.87; p < 0.001) at all early (1-6 h) post-operative time points following LC.



This PRCT shows significantly improved pain control with somatovisceral pain blockade over non-opioid/opioid analgesic combinations following LC for symptomatic cholelithiasis. For centers not utilizing adjunctive local anesthetic for LC, this topical use of bupivacaine may improve patient comfort during recovery. This trial was registered on www.ClinicalTrials.gov NCT# 01972620.
Clinic of Abdominal, Endocrine and Transplantation Surgery, Clinical Center of Vojvodina, Novi Sad, Serbia. mlprotic@gmail.com.|Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia. mlprotic@gmail.com.|California Oncology Research Institute, Santa Monica, CA, USA. mlprotic@gmail.com.
Mladjan
M
Protic
Clinic of Abdominal, Endocrine and Transplantation Surgery, Clinical Center of Vojvodina, Novi Sad, Serbia.|Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.
Radovan
R
Veljkovic
University of California Los Angeles, Los Angeles, CA, USA.|California Oncology Research Institute, Santa Monica, CA, USA.|John Wayne Cancer Institute, Santa Monica, CA, USA.
Anton J
AJ
Bilchik
Health Center "dr Nika Labovic", Berane, Montenegro.
Ana
A
Popovic
Clinic of Abdominal, Endocrine and Transplantation Surgery, Clinical Center of Vojvodina, Novi Sad, Serbia.|Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.
Milana
M
Kresoja
California Oncology Research Institute, Santa Monica, CA, USA.|Department of Surgery, Hadassah Hebrew University Medical Center, Jerusalem, Israel.
Aviram
A
Nissan
California Oncology Research Institute, Santa Monica, CA, USA.|Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
Itzhak
I
Avital
California Oncology Research Institute, Santa Monica, CA, USA.|Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
Alexander
A
Stojadinovic
D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use*; D000772:Anesthesia, Local; D000779:Anesthetics, Local / Q000627:therapeutic use*; D002045:Bupivacaine / Q000627:therapeutic use*; D017081:Cholecystectomy, Laparoscopic / Q000379:methods*; D002769:Cholelithiasis / Q000601:surgery*; D004008:Diclofenac / Q000627:therapeutic use; D004177:Dipyrone / Q000627:therapeutic use; D004311:Double-Blind Method; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D007274:Injections, Intraperitoneal; D020910:Ketorolac / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D059408:Pain Management; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy / Q000517:prevention & control*; D011446:Prospective Studies; D016037:Single-Blind Method; D064232:Visual Analog Scale; D055815:Young Adult
D000700:Analgesics; D000779:Anesthetics, Local; D004008:Diclofenac; D004177:Dipyrone; D002045:Bupivacaine; D020910:Ketorolac
Analgesia; Cholelithiasis; Gallstones; Laparoscopic cholecystectomy; Pain