1

Introduction

The process of recovery after surgery and anesthesia is multifaceted and depends on patient, surgical, and anesthetic factors. A study done by Fecho et al. emphasized that severe postoperative pain is experienced by nearly 60 % of patients undergoing mastectomy, having a numeric rating scale (NRS) of about 5. The complex innervation of the breast, intense tissue dissection in modified radical mastectomy (MRM), and inadequately managed pain in the immediate postoperative period would significantly affect the quality of recovery (QoR) ^, and increase the risk for the development of chronic pain syndromes.

Quality of Recovery-15 (QoR-15) is a reliable questionnaire for evaluating the level of post- operative recovery. It has 15 inquiries designed to assess five distinct domains: physical autonomy, pain, well-being, patient assistance, and emotional condition. The QoR-15 values span from 0 indicating an exceedingly low QoR and 150 representing an outstanding QoR. The average duration required to finish assessment using QoR-15 questionnaire is less than 3 min, indicating its therapeutic usefulness.

The majority of studies quantify quality of recovery using physiological indicators like pain scores, total opioid consumption, opioid-related side effects, time to recovery, and incidence of major morbidity and mortality. A change of 10 in QoR-15 scores was noted after preoperative single injection erector spinae plane block (ESPB) highlighting improvement in QoR following MRM. QoR-15 scores in MRM patients decreased after pectoral nerve (PEC II) block and local infiltration with a median difference −2 between two groups. General anesthesia (GA) with S-ketamine in patients undergoing MRM has been suggested to enhance early QoR-15 score, with a score of 110 in pain, physical comfort, and emotional state. Similarly, use of intravenous (IV) lignocaine has been shown to improve QoR-15 at 24 h compared to standard management in control group.

Recently a modified peri‑paravertebral block has been introduced for postoperative analgesia in patients undergoing MRM. In this block, the injection point lies posterior to superior-costo-transverse-ligament (SCTL) between the two adjacent transverse processes or at the midpoint of two transverse processes and the pleura. This block is known as mid- point transverse process to pleura block (MTPB). It is expected to have a better safety profile as compared to thoracic paravertebral block (TPVB) and ESPB. Limited literature is available regarding the QoR in patients receiving MTPB when used with dexamethasone or dexmedetomidine in patients undergoing breast surgeries. The present study aimed to compare the impact of dexamethasone and dexmedetomidine on QoR after single- shot MTPB in patients undergoing MRM for carcinoma (CA) breast.

2

Methods

This study was a prospective, randomized, assessor- blinded conducted at the Department of Anaesthesia and Intensive Care, in collaboration with the Department of General Surgery, of a tertiary care hospital. The protocol of the study was approved by the Institutional Ethics Committee and registered in the Clinical Trial Registry of India (CTRI). Informed consent was obtained from all the included patients before surgery. The study adhered to principles in the Declaration of Helsinki and is according to CONSORT guidelines.

Females posted for MRM with American Society of Anesthesiologists Physical Status (ASA PS) class 1–2 with an age greater than 18 years were included in the study. Those who refused to consent, ASA PS 3–4 females with severe respiratory, cardiovascular, liver, or pre-existing neurological deficit, with skin infection at the block site, allergy to study drugs, coagulation abnormalities (INR >1.5, thrombocytopenia), recent history of use of analgesic/steroid drugs, pregnant females, and those with a BMI ≥40 kg/m ² were excluded.

All the patients had complete pre-anesthesia checkup with relevant investigations. Patients were explained about the QoR-15 questionnaire and Numerical Rating Score (NRS) for pain (0-no pain, 10-worst pain). Patients were fasted and premedicated as per the departmental protocol.

Standard monitoring, including an electrocardiogram, pulse oximetry (SpO ₂ ), non-invasive blood pressure (NIBP), and capnography (after intubation), was done. The same technique of GA was used in both groups. Induction for GA was done with propofol (2–3 mg/kg), fentanyl (2mcg/kg) followed by vecuronium bromide (0.1mg/kg) to facilitate endotracheal intubation. Maintenance of anesthesia was done with oxygen, nitrous oxide, and sevoflurane (0.6–1 MAC).

The block was given after the induction of anesthesia and before the start of the surgical procedure. All patients were turned in a lateral position, with the site to be blocked being non-dependant. The anesthesiologist (SW) who performed the block was not blinded to group allocation. Participant randomization was conducted utilizing a computer-generated, opaque, sealed envelope method to ensure allocation concealment. Each envelope was opened immediately prior to administering the block, ensuring unbiased intervention allocation.

Decoding of the envelopes was done after completion of the study, thereby preserving the masking of group assignments until data collection was finalized.

Patients received USG MTPB at T ₄ -T ₅ level. In group dexamethasone, 30 patients received unilateral single- shot MTPB with 15 ml of 0.75 % ropivacaine and dexamethasone 0.1 mg/kg to make a total volume of 18 ml. In group dexmedetomidine, 30 patients received unilateral single- shot MTPB with 15 ml of 0.75 % ropivacaine and dexmedetomidine 1 mcg/kg to make a total volume of 18 ml.

After skin preparation, a high frequency linear ultrasound probe was put in the midline in craniocaudal orientation at the T ₄ -T ₅ level. Then the probe was shifted approximately 2.5–3 cm laterally to locate the transverse process (TP). Care was taken to differentiate rib and TP as advocated by Karmarkar et al. In between the two acoustic shadows of adjacent TP (T ₄ and T ₅ ), an acoustic window was being produced by SCTL, intertransverse ligaments, paravertebral space (PVS), and pleura. Once all these were captured on the same US image, a 22-G, 50 mm needle was inserted out- of- plane technique and confirmation of the plane was done using hydrosection. Then the mixture of drug i.e. LA along with adjuvant (18 ml) was deposited at the midpoint between the two transverse processes above the SCTL and pleura.

After block, patients were then turned to the supine position, and the surgical procedure was allowed. Hemodynamic parameters of each patient i.e., HR, NIBP, and SpO ₂ were recorded before the block, at the time of the block, and every 5 min up to 30 min following the block. Any observed complications related to block, such as bradycardia, hypotension, arrhythmias, etc., were recorded. During surgery, the two consecutive rises in SBP by 20 % were managed with repeated IV bolus doses of fentanyl 10 mcg each. Conversely, SBP decreased by 20 % from baseline and was managed with boluses of Ringer lactate and 3–6 mg injection of mephentermine based on the hemodynamic status. For bradycardia with HR < 40 beats/min, injection atropine 0.6 mg was given. For preventing postoperative nausea and vomiting (PONV), inj ondansetron at a dose of 0.1 mg/kg was given 15 min prior to the conclusion of surgery.

After reversing with neostigmine- glycopyrrolate and extubation, patients were shifted to PACU. Patients were observed in PACU for 2 h and then shifted to the ward and monitored there for 24 h. Postoperative follow-up was performed by another anesthesiologist (GG) blinded to the study drugs.

The pain scores on a NRS at rest and on arm movement were recorded at 1, 4, 8, 12, and 24 h by GG. Patient satisfaction and future willingness to undergo repeat peripheral nerve block was recorded as per with four levels [not satisfied [NS], partially satisfied [PS], satisfied [S], and very satisfied [VS].

The time from the institution of the block to the time for the first analgesic request in the postoperative period was recorded. The first analgesic request was defined as an NRS ≥ 3, and this was taken as the duration of MTPB. Any patient having pain (NRS ≥ 3) was administered IV PCM 1 gm and observed for 20 min. If there was no reduction in pain, IV tramadol 1.5 mg/kg was given slowly over 20 min along with injection ondansetron 0.15 mg/kg. The assessment of QoR after MRM was done using the QoR-15 questionnaire at 24 h postoperatively.

The primary outcome measure of the study was to determine QoR, assessed using QoR-15 scale at 24 h postoperatively. The secondary outcomes of this study were to determine the duration of analgesia, total cumulative dose of analgesic (PCM and tramadol) consumption in 24 h after surgery, NRS scores at rest and on arm movements measured at the aforementioned different time frames, patient satisfaction with block and future willingness to undergo repeat peripheral nerve block, and any side effects if any.

Sample size calculation based on the global QoR-15 score. A change of 8 for the QoR-15 scores is considered to represent a clinically relevant difference. Based on the study done by Moorthy et al. , the minimum clinically important difference in QoR-15 was 8.0 and SD of QoR-15 scores was in the order of 16 (range of QoR score is 1–150). Using QoR score as our primary outcome, the sample size was calculated with power of 80 % and 5 % level of significance; our sample size per group was 30, hence the sample size of the study was 60.

The data entry was done in the Microsoft Excel spreadsheet and coded. SPSS (version 26.0) software was used for final analysis. The categorical variables were presented in the form of numbers and percentages (%). The quantitative variables like demographic and hemodynamic variables were estimated using the means ± SD and as median with 25th and 75th percentiles (interquartile range). The normality of data was verified by using the Shapiro-Wilk test. Non-parametric tests were used to quantify the data that did not follow a normal distribution. The generalized estimating equations method was used to find the difference in hemodynamic parameters and NRS score between the two groups over time. The quantitative not normally distributed data, such as the QoR-15 score, time to first analgesia, hemodynamic variables, NRS scores at each of the timepoints, were analyzed using the Mann-Whitney test. An Independent t-test was used to analyze quantitative and normally distributed data. The association of the qualitative variables were analyzed using the Chi-Square test. Fisher’s exact test was used in case any cell had an expected value of less than 5. A P value of less than 0.05 was considered statistically significant.

3

Results

Seventy patients were found to be eligible, out of which 10 patients were excluded from the study as 6 patients declined to give consent for the block and the surgery got postponed in another 4 patients ( Fig. 1 CONSORT). Demographic characteristics were comparable among groups ( table 1 ).

Consort Flow Diagram.

Related posts:

Malignant hyperthermia incidence in the kids inpatient database after the release of Sugammadex Advanced forecasting of emergency surgical case arrivals: Enhancing operating room performance Effect of adding fentanyl to bupivacaine in ultra-sound guided erector spinae plane block (ESPB) in modified radical mastectomy surgeries: A randomized trial Improving on-time surgical starts through a perioperative stop and huddle Mapping the nursing literature on patient safety in the operating room: A bibliometric analysis Effects of intrathecal dexmedetomidine vs. magnesium sulfate on post-operative shivering for cesarean delivery: A double-blind randomized clinical trial

Stay updated, free articles. Join our Telegram channel

Join