Breast cancer is the most common cause of cancer in women. Surgery, pain, opioid use, stress hormones and immune-suppression are suspected to have an influence on cancer recurrence. Animal studies have shown that opioids, volatile anesthetics, thiopental, and ketamine, could inhibit natural killer cell (NK) activity and cause cancer metastasis. But propofol has anti-inflammatory properties and aids in the preservation of NK cell activity.

Breast surgeries are commonly performed under balanced general anaesthesia along with regional plane blocks to reduce the consumption of opioids. However, limitations include technical difficulties and increased possibilities of complications like pneumothorax. Moreover use of blocks alone as an anaesthetic technique is not feasible. We hypothesized that the use of thoracic epidural anaesthesia would provide complete anaesthesia for performing modified radical mastectomy thereby reducing the postoperative complications, ICU and hospital stay and reduced health care cost. Primary objective is to compare post operative pain score between the two groups. Secondary objectives include incidence of postoperative hoarseness of voice, cough, PONV, intra operative and postop analgesic requirement, duration of hospital and ICU stay, anaesthetic cost, patient and surgeon satisfaction.

Methods

This prospective, randomised study will be conducted after obtaining approval from hospital ethical committee, clinical trial registry of India (CTRI) and informed written consent from patients.  Patients aged 18–60 years, of the American Society of Anaesthesiologists (ASA) physical status 2–3 undergoing unilateral modified radical mastectomy will be included in this study. Patients with any contraindications to epidural, infection at the site of the planned epidural placement, any coagulation disorders, or known allergy to lignocaine or any anaesthetic drug will be excluded from the study.

The patients will be randomly assigned into two equal groups, G and E based on computer-generated random sequence of numbers. Concealment will be achieved by closed envelope technique.  Patients in both groups will receive oral ranitidine 150 mg, metoclopramide10 mg, and alprazolam 0.25 mg on the night before surgery and ranitidine 150 mg and metoclopramide 10 mg on the morning of surgery. In the operation theatre, intravenous (IV) cannula will be inserted and monitoring with electrocardiography, noninvasive blood pressure monitor, and pulse‑oximeter will be done. Standard general anaesthesia protocol will be followed in group G. Patients will be preoxygenated with 100% O₂; glycopyrrolate 0.2 mg, midazolam 2 mg, and fentanyl 2 µg/kg will be given intravenously. They will then be induced with IV propofol 1.5–2.5 mg/kg till there is loss of response to verbal Command and patient becomes apnoeic. Classic LMA size 3/4 will be inserted after full deflation. Patient will be maintained on O₂, N2O and isoflurane 0.5%–1.5%. LMA cuffs will be filled with 20/30 ml of room air. Patients will be maintained on spontaneous ventilation.

Patients in group E, will be placed in left lateral position and under strict aseptic precautions epidural catheter will be placed in T5-T6 using 18 gauge Tuohy needle under mild sedation with 10-20mg of titrated doses of propofol. Supplemental oxygen 5 L/min will be administered through a face mask for the entire duration of the surgery. The epidural catheter will be inserted 3-5cm into the epidural space. A test dose of 3 mL of  2% lignocaine with epinephrine 1:200,000 will be given to excludE intravascular or intrathecal injection.  Titrated dose of 5–8 mL of 2% lignocaine will be injected through the catheter and anaesthetic dermatomal levels achieved will be determined by a pinprick. Following this, a titrated infusion of the same drug will be maintained.

Toward the end of the surgery, IV ondansetron 4 mg and IV paracetamol 1 g will be given to patients in both groups and the surgeon will give local infiltration with 5–10 mL of  2% lignocaine. In group G, on completion of the surgery, LMA will be removed after suctioning and deflating the cuff. The epidural catheter is removed at the end of surgery in group E. Four hours after surgery all patients will receive oral paracetamol 650 mg 8th hourly. Patients will be given rescue analgesia with IV ketorolac 1mg.kg^−1 if the patient complained of pain. The total dose of ketorolac given in the first 24 h will be noted for both groups.

Postoperative sore throat, cough, hoarseness, VAS scores, nausea, vomiting, monitoring will be done in the Intensive Care Unit (ICU) by the anaesthetist who will be blinded to the group allocation and the responses will be noted at 0, 2, 4, 12, and 24 h. The patients will be asked to grade POST, cough, and hoarseness using a predefined category scale with scores 0–3 and nausea vomiting will be graded as 0-2. Total intra-operative, as well as post-operative opioid consumptions, will be documented. The incidence of postoperative side effects (e.g., nausea, vomiting, dizziness), duration of the postanesthesia care unit and hospital stays, was documented. Pain intensity will be assessed using numerical pain scale 0–10 (0=no pain to 10=worst imaginable pain). Postanesthesia recovery was evaluated by using the modified Aldrete score system involving the level of consciousness, motor activity, respiration, and circulation. An Aldrete score of 10 (patient fully awake, oriented, and comfortable, with stable cardiovascular and respiratory signs) will be used for discharge from the postanesthesia care unit. Home readiness was assessed by the operating surgeon.  Patient satisfaction with the anaesthetic experience was noted. All were asked to rate their overall experience with the anaesthetic technique as “satisfactory” or “unsatisfactory.”We will also be comparing the anaesthesia charges between the two groups.