A randomized, double-blind, placebo-controlled trial of preemptive analgesia with bupivacaine in patients undergoing mastectomy for carcinoma of the breast

Abstract

SummaryBackgroundIn 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.Material/MethodsParticipants 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.ResultsOut 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.ConclusionsPreemptive 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.

The analgesic effect of wound infiltration with local anaesthetics after breast surgery: a qualitative systematic review

“…The 10 trials all included breast surgery, but the specific procedure in question varied. Three trials investigated mastectomy, four trials partial or segmental mastectomy, and three studies breast reduction, excision of benign lump and unspecified breast surgery, respectively …”

“…In four of the included trials, breast surgery was combined with axillary lymph node dissection, while three trials included mastectomy alone or in combination with axillary lymph node dissection …”

“…Seven of the 10 included trials had one or more domains with ‘unclear’ or ‘high risk’ of bias, and only three trials were evaluated to have ‘low risk’ in all five domains (Table ) . Three of the seven studies with high risk of bias, and all three studies with low risk of bias, demonstrated statistically significant results (Table ).…”

“…In five of the included trials, VAS scores in the control groups were below 30 mm, which may have compromised internal sensitivity (Table ).…”

Current World Literature

“…[35] & Gallacher K, May CR, Montori VM, Mair FS. Preferences of people with advanced heart failure-a structured narrative literature review to inform decision making in the palliative care setting.…”