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

Jacek Zielinski, Radoslaw Jaworski, Irmina Smietanska, Ninela Irga, Maria Wujtewicz, Janusz Jaskiewicz, Jacek Zielinski, Radoslaw Jaworski, Irmina Smietanska, Ninela Irga, Maria Wujtewicz, Janusz Jaskiewicz

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.

Material/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.

Figures

Figure 1
Figure 1
Trial algorithm. US – Ultrasound Imaging; MM – Mammography; po. – per os; iv. – intravenous; bw. – body weight; VAS – Visual Analogue Scale; PCA – Patient Controlled Analgesia; hrs – hours.
Figure 2
Figure 2
CONSORT diagram showing flow of participants through the trial.
Figure 3
Figure 3
Diagram of mean VAS score in postooperative period in patients in group A (bupivacaine) and group B (placebo).

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