Efficacy of Preoperative Ultrasound Guided Pectoral Nerve Block for Intraoperative Opioid Sparing Effect and Postoperative Analgesia in Patients Undergoing Surgery for Breast Cancer.
Phase: NA
Conditions: Breast Cancer
Sponsor: Gachon University Gil Medical Center

 
 
 
 
 
 
Title : Remifentanil-Sparing E_ect of Pectoral Nerve Block Type II in Breast Surgery 
under Surgical Pleth Index-Guided Analgesia during Total Intravenous Anesthesia 
 
NCT number : NCT03210220 
 
 
Document date : June 16, 2019 
 
 

The ethics committee of Gachon University Gil Hospital approved this study. The study was 
registered at www.ClinicalTrials.gov (NCT03210220) prior to patient recruitment. Written informed 
consent was provided by all participants.  
The inclusion criteria for this study were the following: women, aged between 20 and 65 years, 
with an American Society of Anesthesiologists physical status of 1 or 2, who were scheduled for 
BCS with SLNB for the treatment of breast cancer. The exclusion criteria were as follows: patients 
receiving anticoagulant therapy, those with bleeding disorders, hypersensitivity to local anesthetics, 
body mass index greater than 35 kg/m2, the presence of spine or chest wall deformities, and 
pregnancy. Patients either received the Pecs II block (Pecs group) or did not receive it (control 
group). One anesthesiologist (JJC) performed all blocks in the Pecs group enrolled patients. After 
the intervention, the participants and the investigator responsible for the study outcome 
assessment were blinded. 
Premedication was not given. Electrocardiography, non-invasive blood pressure monitoring and 
the bispectral index (BIS vista monitor revision 3.0; Aspect Medical Systems, Norwood, MA, USA) 
were applied in the operating room. SPI (S5 monitor; GE Healthcare, Helsinki, Finland) was 
monitored using a pulse oximeter sensor attached to the index finger contralateral to the 
operative site. For anesthesia induction and maintenance, lidocaine (1 mg/kg), propofol, and 
remifentanil were administered. The effect-site concentrations of propofol and remifentanil were 
automatically calculated by Schnider’s [15] and Minto’s [16] pharmacokinetic models, respectively, 
using a target-controlled infusion (TCI) pump (Orchestra; Fresenius Kabi, Bad Homburg, Germany). 
To facilitate orotracheal intubation, rocuronium (0.8 mg/kg) was administered after loss of 
consciousness. 
For the patients in the Pecs group, a linear ultrasound probe was placed on the lateral third of the 
clavicle with bilateral abduction in the supine position. After identifying the axillary vein and artery, 
the ultrasound probe was positioned inferio-laterally, between the 3rd and 4th ribs, and then the 
pectoralis major and minor, and serratus anterior muscles were confirmed. The needle was 
advanced in a medio-lateral direction in-plane view of the ultrasound. For the Pecs II block, a total 
30 mL of 0.5% ropivacaine was injected. First, the needle tip was advanced into the fascia between 
the pectoralis major and minor muscles and 10 mL of 0.5% ropivacaine was injected. Thereafter, 
the needle tip was advanced into the tissue plane between the pectoralis minor and serratus 
anterior muscles, and 20 mL of 0.5% ropivacaine was injected in a similar manner. 
Fifteen minutes after the Pecs II block, a skin incision was made for the scheduled surgery. During 

the surgery, the remifentanil dose was adjusted to a target SPI of 20–50 and the propofol dose 
was adjusted to a target BIS of 40–60, using a TCI pump. When the SPI was >50 or <20, the 
remifentanile effect-site concentration was adjusted to a step of 0.5 ng/kg with intervals of 1 min 
or more. When the BIS value was >60 or <40, the propofol effect-site concentration was adjusted 
to a step of 0.5 g/kg with intervals of 1 min or more. When the systolic blood pressure dropped 
below 90 mm Hg or below 80% of the baseline value, ephedrine 5 mg was administered 
intravenously at 2-min intervals. If the heart rate (HR) dropped below 50 beats/min, atropine 0.5 
mg was administered intravenously. 
Patient-controlled analgesia (PCA) (Accufuser plus®, Wooyoung medical, Seoul, Korea) was 
provided for 48 h with ketorolac 120 mg and sufentanil 50 g in normal saline 100 mL, (basal 
infusion rate 2 mL/h, 0.5 mL intermittent bolus with a 15 min lock-out interval). For preventing 
PONV, ramosetron 0.3 mg was administered intravenously before the end of the surgery. 
In the postanesthetic care unit (PACU), the postoperative pain was evaluated using an 11-point 
numerical rating scale (NRS) (0–10) and was accessed immediately after arrival at the PACU, 1 h 
postoperatively, 16–24 h postoperatively, and 24–48 h postoperatively. Fentanyl 50 g bolus was 
administered as a rescue analgesic agent when the NRS was greater than 5 points. 
The primary outcome was the intraoperative remifentanil consumption, and the secondary 
outcomes were the postoperative pain score and rescue analgesic requirement. The sample size 
was calculated based on the previous study of breast cancer surgery under TIVA. The 
intraoperative remifentanil consumption was 10.9  2.9 g/kg/h and 7.3  3.3 g/kg/h in the control 
and Pecs groups, respectively. With type 1 error of 0.05 and a power of 0.9, the study required 14 
patients in each group. Considering the possible drop-out, 20 patients were included in each 
group. Patients were randomly assigned to the Pecs group (n = 20) or the control group (n = 20), 
based on a randomized list generated with Excel 2013 (Microsoft office, Redmond, WA, USA), 
without stratification.  
Data were analyzed using SPSS 19.0 (SPSS, Chicago, IL, USA). Values were presented as number of 
patients, medians (interquartile ranges; IQR) or mean standard deviation (SD). The Kolmogorov-
Smirnov test was performed for the normality test of continuous variables. The normally 
distributed data were presented as mean SD and the skewed data were presented as median 
(IQR). An independent t-test was used for normally distributed variables (intraoperative dosages of 
remifentanil and propofol), and the Mann–Whitney U Test was used for variables with a non-
normal distribution (postoperative pain scores). The chi-squared test or Fisher’s exact test was 

used to analyze the categorical data (the use of atropine, ephedrine and rescue analgesics), where 
appropriate. Repeated, measured ANOVA was used for accessing the intergroup differences of 
MBP, HR, SPI, and BIS over time. Statistical significance was accepted for p value < 0.05. 
 
Primary completion date : December 30, 2018