Zielinski, J., Jaworski, R., Smietanska, I., Irga, N., Wujtewicz, M., & Jaskiewicz, J. (2011). A randomized, double-blind, placebo-controlled trial of preemptive analgesia with bupivacaine in patients undergoing mastectomy for carcinoma of the breast. Medical Science Monitor: International Medical Journal of Experimental and Clinical Research, 17(10), CR589–597.

To test the effect of bupivacaine, applied in the area of surgical incision, on the pain experienced by postmastectomy patients; to see how the bupivacaine affected use of analgesics  

Before mastectomy, women were randomized to receive bupivacaine application or saline placebo. The bupivacaine group received 100 mg bupivacainum hydrochloricum dissolved in normal saline. The control group received normal saline. Bupivacaine and saline were administered in the same way: subcutaneously, along the intended line of incision, 15 minutes before the operation. All patients received standard oral premedication: 7.5 mg midazolam. Anesthesia consisted of propofol, 2 mg/kg body weight; vecuronium, 0.6 mg/kg; and fentanyl, 2 mcg/kg. After surgery, each patient had the option of patient-controlled analgesia, which consisted of standard drug concentrations based on body weight. IV metamizole, 1g, was administered every 6 hours. Pain was measured at 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, and 48 hours postoperatively. Total analgesic consumption was recorded.

• Authors included 106 patients in the intention-to-treat analysis.   
• Mean patient age was 59.4 years. The age range of patients was 24–83 years.
• All the patients were female.
• All participants had stage I–III breast cancer.
   

• Single site
• Inpatient
• Poland
   

Active treatment

Randomized double-blind placebo-controlled trial

Visual analog scale (VAS), with a 0–10 scale, to measure pain severity

Compared to patients receiving placebo, patients receiving bupivacaine reported significantly lower pain severity at the 4th (p = 0.004) and 12th  p = 0.02) postoperative hours. Patients receiving bupivacaine used less fentanyl (p = 0.011). Between the 4th and 12th postoperative hours, those receiving bupivacaine used less PCA morphine (p = 0.02) than did the control group. The pattern of VAS scores was similar in both groups, with a spike in pain during the first postoperative hour and a gradual decline thereafter. Across the first 12 hours, pain scores in the bupivacaine group were consistently lower than the scores in the control group. Authors noted no differences between groups in regard to time to first morphine dose or total amount of morphine used during the postoperative follow-up.

Preoperative subcutaneous injection of bupivacaine to the site of surgical incision was effective in reducing patients' pain severity and morphine consumption during the first 12 hours after mastectomy.

• Authors provided very little disease-related or demographic information about the sample. 
• Authors provided no information about variation in the extent of the surgical procedure, patient to patient.
• Median pain scores reported for both groups were 0 at individual hourly time points. This raises the question of the actual clinical relevance of findings.
• Analysis was sometimes based on VAS scores and sometimes on nonquantitative variables.

Findings provide support for the use of bupivacaine injection to relieve postmastectomy pain. Nurses can advocate for consideration of this approach as part of surgical pain management. Note that these results are not immediately generalizable to other surgical populations.