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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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Related in: MedlinePlus

CONSORT diagram showing flow of participants through the trial.
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f2-medscimonit-17-10-cr589: CONSORT diagram showing flow of participants through the trial.

Mentions: A total of 121 women, admitted during the period from July 2009 till March 2010 to the Department of Oncological Surgery, Medical University of Gdansk, Poland for surgical treatment of breast carcinoma, were evaluated before enrollment to the study; 112 patients were qualified to the study; and 9 were excluded from participation. Seven of the excluded cases did not give an informed consent, 1 was found to be allergic to metamizole and 1 had a history of psychiatric disorder. The 112 patients enrolled to the study were subject to randomization into 2 groups – group A (n=57) treated with bupivacaine along the line of the planned surgical incisions prior to main surgery, and group B treated with placebo (n=55). After the surgery, 3 patients were excluded from group A – the first because the advanced stage of the disease necessitated modification of the surgery due to neoplastic infiltration of the axillary vein; the second due to difficulties in anesthesia and objections of the anesthesiologist regarding metamizole administration; and the third due to necessity of re-operation on the second day after surgery due to post-operative bleeding. Similarly, after the surgery, 3 patients were excluded from group B (placebo) – the first because of the advanced stage of the disease with neoplastic infiltration of the pectoralis major muscle; and the reaming 2 cases due to objections of the anesthesiologist regarding metamizole administration because of difficulties during anesthesia. Eventually, 106 patients were subjected to intention-to-treat, analysis and follow-up – these included 54 women in group A (bupivacaine) and 52 women in group B (placebo). The follow-up was completed in March 2010. The flow diagram of the trial is presented in Figure 2. None of the patients participating in the study developed any adverse effect related to the study protocol. Clinico-pathological characteristics of the study participants are summarized in Table 1. Statistically significant lower intraoperative fentanyl consumption was observed in group A (bupivacaine) vs. group B (placebo); mean fentanyl consumption was 0.38 and 0.43, respectively (p=0.011). In group A (bupivacaine) lower morphine (administered using PCA) consumption between the 4th and 12th hour after surgery was observed vs. consumption in group B (placebo) – 1.24 mg vs. 2.35mg, respectively (p=0.02). For group A (bupivacaine) lower morphine consumption (however, not reaching the level of statistical significance) was also observed for the other time intervals (during the first, the first 4, and the first 12 hours after surgery and between the 1st and 4th hour after surgery) mean values 0.72 mg vs. 1.23 mg; 3.3 mg vs. 4.15; 3.68 mg vs. 5.31 mg and 3.72 mg vs. 4.31, respectively, p>0.05) (Table 2). No significant differences between groups A and B were observed with respect to the time to the first dose of morphine administered using PCA in the post-operative period (mean 123 min vs. 175 min), total amount of morphine administered using PCA (mean 5.49 mg vs. 6.67mg), number of attempts to launch PCA during lockout (mean 2.2 vs. 1.2), and number of morphine doses administered using PCA (mean 3.1 vs. 3.9).


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)

CONSORT diagram showing flow of participants through the trial.
© Copyright Policy
Related In: Results  -  Collection

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

f2-medscimonit-17-10-cr589: CONSORT diagram showing flow of participants through the trial.
Mentions: A total of 121 women, admitted during the period from July 2009 till March 2010 to the Department of Oncological Surgery, Medical University of Gdansk, Poland for surgical treatment of breast carcinoma, were evaluated before enrollment to the study; 112 patients were qualified to the study; and 9 were excluded from participation. Seven of the excluded cases did not give an informed consent, 1 was found to be allergic to metamizole and 1 had a history of psychiatric disorder. The 112 patients enrolled to the study were subject to randomization into 2 groups – group A (n=57) treated with bupivacaine along the line of the planned surgical incisions prior to main surgery, and group B treated with placebo (n=55). After the surgery, 3 patients were excluded from group A – the first because the advanced stage of the disease necessitated modification of the surgery due to neoplastic infiltration of the axillary vein; the second due to difficulties in anesthesia and objections of the anesthesiologist regarding metamizole administration; and the third due to necessity of re-operation on the second day after surgery due to post-operative bleeding. Similarly, after the surgery, 3 patients were excluded from group B (placebo) – the first because of the advanced stage of the disease with neoplastic infiltration of the pectoralis major muscle; and the reaming 2 cases due to objections of the anesthesiologist regarding metamizole administration because of difficulties during anesthesia. Eventually, 106 patients were subjected to intention-to-treat, analysis and follow-up – these included 54 women in group A (bupivacaine) and 52 women in group B (placebo). The follow-up was completed in March 2010. The flow diagram of the trial is presented in Figure 2. None of the patients participating in the study developed any adverse effect related to the study protocol. Clinico-pathological characteristics of the study participants are summarized in Table 1. Statistically significant lower intraoperative fentanyl consumption was observed in group A (bupivacaine) vs. group B (placebo); mean fentanyl consumption was 0.38 and 0.43, respectively (p=0.011). In group A (bupivacaine) lower morphine (administered using PCA) consumption between the 4th and 12th hour after surgery was observed vs. consumption in group B (placebo) – 1.24 mg vs. 2.35mg, respectively (p=0.02). For group A (bupivacaine) lower morphine consumption (however, not reaching the level of statistical significance) was also observed for the other time intervals (during the first, the first 4, and the first 12 hours after surgery and between the 1st and 4th hour after surgery) mean values 0.72 mg vs. 1.23 mg; 3.3 mg vs. 4.15; 3.68 mg vs. 5.31 mg and 3.72 mg vs. 4.31, respectively, p>0.05) (Table 2). No significant differences between groups A and B were observed with respect to the time to the first dose of morphine administered using PCA in the post-operative period (mean 123 min vs. 175 min), total amount of morphine administered using PCA (mean 5.49 mg vs. 6.67mg), number of attempts to launch PCA during lockout (mean 2.2 vs. 1.2), and number of morphine doses administered using PCA (mean 3.1 vs. 3.9).

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