title: Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital.
abstract: BACKGROUND
  Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively.
  
  
  OBJECTIVE
  To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery.
  
  
  METHODS
  A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection.
  
  
  METHODS
  Community hospital with general surgery residency program with all cases performed by colorectal surgeons.
  
  
  METHODS
  Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection.
  
  
  METHODS
  Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine.
  
  
  METHODS
  Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation.
  
  
  RESULTS
  There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test).
  
  
  CONCLUSIONS
  Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain.
  
  
  CONCLUSIONS
  Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon resection. (ClinicalTrials.gov: NCT02052557).
authors: 1 General Surgery, Skiff Medical Center, Newton, Iowa 2 Department of Surgery, Mercy Medical Center, Des Moines, Iowa.
authors: Rachel A
authors: RA
authors: Knudson
authors: Paul W
authors: PW
authors: Dunlavy
authors: Jan
authors: J
authors: Franko
authors: Shankar R
authors: SR
authors: Raman
authors: Soren R
authors: SR
authors: Kraemer
mesh_terms: D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use; D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000627:therapeutic use; D002045:Bupivacaine / Q000008:administration & dosage* / Q000627:therapeutic use; D003082:Colectomy; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006764:Hospitals, Community; D006801:Humans; D057194:Intention to Treat Analysis; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy / Q000517:prevention & control*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D000779:Anesthetics, Local; D008081:Liposomes; D002045:Bupivacaine