A randomized single-blinded, parallel-arm group feasibility trial evaluating role of pectoral nerve block on serum vascular endothelial growth factor levels in patients undergoing unilateral modified radical mastectomy.

Abstract

Metastatic breast cancer cells carry adult and neonatal variants of NaV1.5 voltage-gated activated Na+ channels involved in cell invasion. We hypothesize that instilling lignocaine near the surgical field to anesthetize the pectoral nerves for analgesia will decrease angiogenesis by blocking voltage-gated activated Na+ channels. Twenty patients undergoing unilateral modified radical mastectomy were randomized in a single-blinded, parallel-arm group feasibility pilot study in two groups. In Group I a catheter was placed between the pectoralis major and minor muscle under direct vision before skin closure. Ten milliliters of 2% lignocaine was given as an initial bolus followed by 10 mL of 2% lignocaine every 8 hours up to 24 hours. Group II did not receive any regional block. Primary measure outcomes were pre and postoperative changes in levels of vascular endothelial growth factor. Secondary outcomes were postoperative pain scores and total rescue analgesia used. Nine patients in each group were analyzed. Baseline demographic data of all females were similar with respect to age, body mass, height and duration of anesthesia. Postoperative mean serum levels of vascular endothelial growth factor were decreased by 46.60% from baseline in Group I, while were increased by 84.27% as compared to preoperative values in Group II. Postoperative average pain scores were less in Group I. Postoperative rescue analgesia in 24 hours in Group I was lower than that in Group II. There was no postoperative adverse event related to catheter or lignocaine administration at given doses. Instilling lignocaine to block pectoral nerves provides better postoperative analgesia and decreases a marker of angiogenesis. The study protocol was approved by the Institutional Ethical Committee of the Tertiary Centre (All India Institute of Medical Sciences Rishikesh India) (No. AIIMS/IEC/19/1002) on August 9, 2019, and the larger expansion trial was prospectively registered on Clinical Trial Registry India (No. CTRI/2020/01/022784) on January 15, 2020.