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

Zielinski J, Jaworski R, Smietanska I, Irga N, Wujtewicz M, Jaskiewicz J - Med. Sci. Monit. (2011)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgical Oncology, Medical University of Gdansk, Gdansk, Poland.

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.

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Diagram of mean VAS score in postooperative period in patients in group A (bupivacaine) and group B (placebo).
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f3-medscimonit-17-10-cr589: Diagram of mean VAS score in postooperative period in patients in group A (bupivacaine) and group B (placebo).

Mentions: Significantly lower pain sensation assessed using the VAS scale was observed in group A (bupivacaine) as compared to group B (placebo) at the 4th postoperative hour (mean VAS score 0.85 vs. 1.69; p=0.004) and at the 12th postoperative hour (mean VAS score: 0.48 vs. 0.96; p=0.02) (Table 2). No statistically significant differences in subjective assessment of pain intensity were observed for the 2 groups at other time intervals – immediately after waking after surgery, and at 1,2,3,8,16,24,36 and 48 hours after surgery (p>0.05). Nonetheless, in group B (placebo) the mean VAS score values were found to be higher at these time intervals (Figure 3).


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

Zielinski J, Jaworski R, Smietanska I, Irga N, Wujtewicz M, Jaskiewicz J - Med. Sci. Monit. (2011)

Diagram of mean VAS score in postooperative period in patients in group A (bupivacaine) and group B (placebo).
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3539479&req=5

f3-medscimonit-17-10-cr589: Diagram of mean VAS score in postooperative period in patients in group A (bupivacaine) and group B (placebo).
Mentions: Significantly lower pain sensation assessed using the VAS scale was observed in group A (bupivacaine) as compared to group B (placebo) at the 4th postoperative hour (mean VAS score 0.85 vs. 1.69; p=0.004) and at the 12th postoperative hour (mean VAS score: 0.48 vs. 0.96; p=0.02) (Table 2). No statistically significant differences in subjective assessment of pain intensity were observed for the 2 groups at other time intervals – immediately after waking after surgery, and at 1,2,3,8,16,24,36 and 48 hours after surgery (p>0.05). Nonetheless, in group B (placebo) the mean VAS score values were found to be higher at these time intervals (Figure 3).

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgical Oncology, Medical University of Gdansk, Gdansk, Poland.

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.

Show MeSH
Related in: MedlinePlus