Analgesic effect of adding calcitonin to bupivacaine in erector spine plane block for breast surgery, a double blind randomised study

Figures & data

Figure 1. The flow diagram of patient progress through the randomized trial.

Table 1. Demographic characteristics, type, and duration of surgery for the studied groups.

		Group B (n= 65)	Group BC (n= 65)	95% CI	P
Age (years)		46.71 ± 9.730	49.20 ± 9.316	-5.80, 0.81	0.138
Weight (kg)		77.63 ± 9.429	79.27 ± 9.774	-4.97, 1.69	0.333
Height (m)		1.69 ± 0.061	1.69 ± 0.060	-0.02, 0.02	1
BMI (kg/m^2)		27.16 ± 3.033	27.72 ± 2.991	-1.60, 0.49	0.292
ASA	1	39 (60.0%)	41 (63.1%)	-	0.718
	2	26 (40.0%)	24 (36.9%)
Surgery	Modified radical mastectomy	22 (33.8%)	24 (36.9%)	-	0.911
	Breast conservational surgery	22 (33.8%)	22 (33.8%)
	Simple mastectomy and axillary clearance	21 (32.3%)	19 (29.2%)
Duration of surgery (minutes)		104.77 ± 14.319	104.92 ± 14.045	- 5.08, 4.77	0.951

Data is expressed as mean and standard deviation or as percentage and frequency. 95% CI: 95% confidence interval of the mean difference between both groups. P is significant when ˂ 0.05. n=Number of patients, BMI=Body mass index, ASA= American Society of Anesthesiologists, B=Bupivacaine group, BC=Bupivacaine Calcitonin group.

Table 2. Postoperative VAS score follow-up and analgesic requirements of the studied groups.

		Group B (n= 65)	Group BC (n= 65)	95% CI	P
VAS	0 hour	1(0-1)	1(0-1)	-0.24, 0.11	0.483
	2 hours	1(0-2)	1(0-1)	-0.42, -0.08	0.112
	4 hours	2(1-4)	1(0-3)	0.53, 1.29	˂ 0.001
	6 hours	4(2-7)	2(0-5)	2.13, 3.01	˂ 0.001
	12 hours	4(1-8)	4(1-6)	0.10, 1.13	0.031
	18 hours	4(1-8)	4(1-7)	-0.05, 1.03	0.091
	24 hours	4(0-8)	4(0-8)	-0.07, 1.18	0.07
Postoperative morphine (mg) (24-h)		7.74 ± 2.117	6.40 ± 1.876	0.54, 2.13	0.001
Intraoperative fentanyl (μg)		116.1±8.74	113.4±14.29	-1.45, 6.77	0.203
Time to first rescue analgesia (hours)		6.60 ± 3.116	12.18 ± 4.969	-7.18, -3.98	˂ 0.001
Patients needed rescue analgesia		57 (87.7%)	45 (69.2%)	-	0.01

Data is expressed as mean and standard deviation or as percentage and frequency. 95% CI: 95% confidence interval of the mean difference between both groups. P is significant when ˂ 0.05. n=Number of patients, BMI=Body mass index, ASA= American Society of Anesthesiologists, B=Bupivacaine group, BC=Bupivacaine Calcitonin group.

Figure 2. Plasma levels of tumor necrosis factor.

T₀=1 h before surgery, T₁=2 h postoperative, T₂=12 h postoperative, T₃=24 h postoperative, TNF-α=tumor necrosis factor, B=Bupivacaine group, BC=Bupivacaine Calcitonin group.*=P is significant when <0.05

Figure 3. Plasma levels of interleukin −6.

T₀=1 h before surgery, T₁=2 h postoperative, T₂=12 h postoperative, T₃=24 h postoperative, IL-6=Interleukin −6, B=Bupivacaine group, BC=Bupivacaine Calcitonin group.*=P is significant when <0.05

Figure 4. Plasma levels of interleukin −10.

T₀=1 h before surgery, T₁=2 h postoperative, T₂= 12 h postoperative, T₃=24 h postoperative, IL-10=Interleukin -6, B = Bupivacaine group, BC = Bupivacaine Calcitonin group.* = P is significant when <0.05

Table 3. Side effect distribution among studied groups.

	Group B (n= 65)	Group BC (n= 65)	P value
Nausea & vomiting	4(6.2%)	2(3.1%)	0.680
Respiratory depression	2(3.1%)	1(1.5%)	1.0
Pruritus	5(7.7%)	2(3.1%)	0.440
Hypotension	3(4.6%)	1(1.5%)	0.619

Data is expressed as percentage and frequency. P is significant when ˂ 0.05. n=Number of patients, B=Bupivacaine group, BC=Bupivacaine Calcitonin group..