Following the approval of the institutional ethical committee and CTRI Registration, we conducted this prospective randomized trial at a tertiary care hospital from August 2020 to December 2021. We included 60 ASA I, II, and III patients aged 18 to 65 years after obtaining written and informed consent. These patients were scheduled for elective chest wall surgeries.
The surgeries encompassed procedures such as fibroadenoma excision, mastectomy, modified radical mastectomy with axillary dissection, synthetic breast expander implantation, breast reconstruction, cardiac pacemaker insertion, anterior thoracotomy, and shoulder surgeries. Patients were excluded from the study if they refused to give consent, were on anticoagulant drugs, had deranged liver function tests (LFTs), had an allergy to local anesthetics, had bleeding diathesis, were pregnant or lactating or had skin ulceration or infiltration of the chest wall at the site of the block.
The PEC1 block involved administering the local anesthetic solution in the plane between the pectoralis major and minor muscles, while the PEC2 block involved administration between the pectoralis minor and serratus anterior muscles.
In the preoperative room, all patients were informed about the NRS for pain at rest and were instructed to rate their pain accordingly, from 0 to 10 (0 indicating no pain, 1 to 3 mild pain, 4 to 6 moderate pain, and 7 to 10 severe pain).
All patients were instructed to fast overnight before surgery and were prescribed a tablet of alprazolam 0.25 mg at bedtime. Baseline parameters such as heart rate (HR), non-invasive blood pressure (NIBP), oxygen saturation (SpO2), temperature, and end-tidal carbon dioxide (ETCO2) were recorded.
Patients were randomly divided into two equal groups according to the Consort statement (
Figure 1) based on the drug administered in the PEC block:
- Group R received an injection of 0.2% ropivacaine 38 mL + 2 mL normal saline (total 40 mL).
- Group F received an injection of 0.2% ropivacaine 38 mL + 2 mL fentanyl (100 mcg) (total 40 mL).
To maintain the triple-blinded nature of the trial, the tasks of preparing the drug, administering the block, and observing the patient for postoperative analgesia for data collection were assigned to different individuals.
Patients were transferred to the operating theater, where ECG, NIBP, SpO2, temperature, and EtCO2 monitors were attached, and an IV line was secured. All patients were induced with general anesthesia, premedicated with inj. midazolam 0.02 mg/kg IV, inj. Glycopyrrolate 0.05 mg/kg IV, inj. ondansetron 4 mg IV, and inj. fentanyl 2 mcg/kg IV. Induction was achieved with inj. propofol 2 mg/kg IV and inj. succinylcholine chloride 2 mg/kg IV. The trachea was intubated with an appropriately sized endotracheal tube with a cuff, which was secured after verifying bilateral equal air entry by auscultation and confirmed with EtCO2.
Patients were maintained on a mixture of 50% oxygen and 50% air, and sevoflurane (MAC 2 - 3%) was used. Inj. atracurium 0.5 mg/kg IV was administered as a muscle relaxant loading dose, with 0.1 mg/kg IV given intermittently for maintenance. Adequate crystalloid Ringer's lactate was administered for maintenance, and blood loss and third space loss were replaced according to NBM hours and ideal body weight.
Upon completion of the surgery and prior to extubation, a USG-guided PEC1 and PEC2 block was administered to the patients according to the group they were allocated to (group R and group F). The PEC block was performed with the patient in a supine position and the ipsilateral upper limb abducted, using a linear USG probe (6 to 13 MHz). The probe was initially placed in the infraclavicular region, then advanced laterally to locate the axillary artery and vein directly above the first rib between the pectoralis major and pectoralis minor for the PEC1 block, where 10 mL of the drug was administered, followed by the PEC2 block, where 20 mL of the drug was administered between the pectoralis minor and serratus anterior.
Parasternal infiltration was performed with 10 mL from a prefilled syringe to provide analgesia for the medial part of the breast (innervated by the supramammary and inframammary nerves). The time of the block was recorded, and vital signs such as pulse, BP, and SpO2 were monitored.
After completing the procedure and once adequate reflexes were regained, patients were administered inj. glycopyrrolate 0.04 mg/kg IV and inj. neostigmine 0.05 mg/kg IV for reversal. Upon regaining consciousness, patients were extubated and then transferred to the recovery room for observation following our hospital’s routine postoperative protocols. Postoperative pain was assessed and managed according to the NRS score.
Vital signs and pain were assessed using the NRS at 0 hours, 30 min, 1, 2, 4, 6, and 12 hours (0 hour was defined as the time when the patient was shifted to the postoperative care unit). If the NRS was < 3, inj. paracetamol 1 gm IV was administered. If the NRS was > 3, inj. fentanyl 10 mcg IV was given every 10 minutes until the NRS was < 3. Therefore, inj. fentanyl was used for immediate pain relief and inj. paracetamol for long-duration pain relief as per our hospital protocol for rescue analgesia.
The primary outcome measures observed and studied were:
(1) Time of first rescue analgesia.
(2) Duration of analgesia (from the time of the block to the time when the first rescue analgesia was administered).
(3) Total cumulative dose of inj. fentanyl and paracetamol were given during the first 24 hours postoperatively.
The secondary outcomes were:
(1) Numeric Rating Scale score in both groups of patients at rest and during movement.
(2) Any adverse effects, such as local anesthesia toxicity, pneumothorax, nausea, vomiting, failure of the block’s effect, or respiratory depression, were noted.
3.1. Statistics
The data were collected and statistically analyzed using SPSS version 26. The data was explored using minimum, maximum, mean, and standard deviation for normally distributed data. Tests applied were the independent t-test or Mann-Whitney test, and the P-value was calculated for comparison and inference between both groups.