title: A randomized, double-blind, placebo-controlled trial of preemptive analgesia with bupivacaine in patients undergoing mastectomy for carcinoma of the breast.
abstract: BACKGROUND
  In this prospective, randomized, placebo-controlled, double-blinded clinical trial we tested the hypothesis that preemptive analgesia with bupivacaine applied in the area of the surgical incision in patients undergoing mastectomy for breast cancer would reduce post-operative acute pain and would reduce the amount of analgesics used during surgery and in the post-operative period.
  
  
  METHODS
  Participants were assigned into 1 of 2 groups--with bupivacaine applied in the area of surgical incision or with placebo. We assessed the intraoperative consumption of fentanyl, the postoperative consumption of morphine delivered using a PCA method, and the subjective pain intensity according to VAS score reported by patients in the early post-operative period.
  
  
  RESULTS
  Out of 121 consecutive cases qualified for mastectomy, 112 women were allocated randomly to 1 of 2 groups--group A (bupivacaine) and group B (placebo). The final study group comprised 106 breast cancer cases. Between the groups, a statistically significant difference was observed with respect to: lower fentanyl consumption during surgery (p = 0.011), lower morphine (delivered by means of a PCA) consumption between the 4-12th postoperative hours (p = 0.02) and significantly lower pain intensity assessed according to VAS score at the 4th and 12th hours after surgery (p = 0.004 and p = 0.02 respectively) for the group A patients.
  
  
  CONCLUSIONS
  Preemptive analgesia application in the form of infiltration of the area of planned surgical incisions with bupivacaine in breast cancer patients undergoing mastectomy decreases post-operative pain sensation, limits the amount of fentanyl used during surgery, and reduces the demand for opiates in the hours soon after surgery.
authors.affiliation: Department of Surgical Oncology, Medical University of Gdansk, Gdansk, Poland.
authors.forename: Jacek
authors.initials: J
authors.lastname: Zielinski
authors.forename: Radoslaw
authors.initials: R
authors.lastname: Jaworski
authors.forename: Irmina
authors.initials: I
authors.lastname: Smietanska
authors.forename: Ninela
authors.initials: N
authors.lastname: Irga
authors.forename: Maria
authors.initials: M
authors.lastname: Wujtewicz
authors.forename: Janusz
authors.initials: J
authors.lastname: Jaskiewicz
mesh_terms: D016058:Analgesia, Patient-Controlled / Q000706:statistics & numerical data; D000779:Anesthetics, Local / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000601:surgery*; D002045:Bupivacaine / Q000627:therapeutic use*; D002277:Carcinoma / Q000601:surgery*; D004311:Double-Blind Method; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage; D006801:Humans; D008408:Mastectomy / Q000379:methods*; D009020:Morphine / Q000008:administration & dosage; D010147:Pain Measurement; D010149:Postoperative Pain / Q000517:prevention & control*; D011300:Preoperative Care / Q000379:methods*; D011446:Prospective Studies
chemical_list: D000779:Anesthetics, Local; D009020:Morphine; D005283:Fentanyl; D002045:Bupivacaine