INTRODUCTION

Breast cancer is the most common malignancy in women; surgery is one of the mainstays of treatment of breast cancer, and modified radical mastectomy is one of the standard treatments.^[1–3] Postoperative pain can seriously reduce the quality of life in patients, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and analgesia during modified radical mastectomy, but their applications are limited by the complicated nature of the procedures and severe complications.^[1–4] 

In recent years, there has been increasing interest on a novel, less invasive nerve block, the pectoral nerve (PECS) block. PECS I block is an interfascial plane block administered between the pectoralis major and the pectoralis minor muscles.  The Pecs I block is a single injection of local anaesthetic between pectoralis major and pectoralis minor muscles at the level of the 3rd rib to anaesthetise the lateral and medial pectoral nerves (LPN and MPN). Indications include surgery limited to pectoralis major e.g. unilateral surgery such as insertion of breast expanders and submuscular prostheses, portacaths and implantable cardiac defibrillators/pacemakers, anterior thoracotomies and shoulder surgery involving the deltopectoral groove.The PECS II block includes the PECS I block combined with a block administered above the serratus anterior muscle at the third rib.^[5,6]The Pecs II block is a modified Pecs I block and can be achieved with one needle insertion point.Local anaesthetic is placed between pectorals major and minor as in Pecs I block and then between pectoralis minor and serratus anterior muscles. This results in local anaesthetic spread under the ligament of Gerdy. The ligament of Gerdy is a thick fascia that gives the concave shape to the axilla. On its medial side it attaches to the lateral side of the pectoral muscle. This second injection will anaesthetise the anteriocutaneous branches of the intercostal nerves, the intercostobrachialis and the long thoracic nerves. Indications are similar to Pecs I with some additions: tumour resections, mastectomies, sentinel node biopsies.The Pecs II block (which also includes the Pecs I block) is an extension that involves a second injection lateral to the Pecs I injection point in the plane between the pectoralis minor and serratus anterior muscles with the intention of providing blockade of the upper intercostal nerves.

Kamiya Yet al observed the ability of PECS block to decrease postoperative pain and anaesthesia and analgesia requirements and to improve postoperative Quality of  Recovery( QoR) in patients undergoing breast cancer surgery.^[7]

Erector spinae plane (ESP) block is one of the newer interfascial techniques with potential applications.  ESP block is an interfascial block that can be performed by superficial or deep needle approach. In superficial needle approach technique, drug is injected between rhomboid major muscle and erector spinae muscle, whereas in the deep needle approach, drug is injected below erector spinae muscle. ^[8]

^{Gurkan Y et al observed that ultrasound guided erector spinae plane block reduces postoperative opioid consumption  following breast surgery. [9]}

Numerous clinical trials have focused on the analgesic potential of the PECS block in breast augmentation surgery, small breast surgery, and breast cancer surgery, and have shown positive results. Analgesia being an important component of anesthetic plan, effective management of postoperative pain is expected to impact perioperative quality of recovery (QoR) positively. QoR-40 score has been shown to be a valid, reliable, responsive tool in variety of surgical settings and, therefore, the best instrument to measure the complex and multidimensional process of postoperative recovery. ^[10-12] As there are very few studies which have compared efficacy of ESP block with PECS block after modified radical mastectomy so this study is planned to compare efficacy of PECS block with Erector Spinae block for quality of recovery and post operative analgesia after modified radical mastectomy.^[13,14]

AIM AND OBJECTIVES

AIM- The aim of study is to compare the efficacy of PECS block and ERECTOR spinae block for postoperative quality of recovery and analgesia after Modified Radical Mastectomy

OBJECTIVE

•      The primary objective of the study is to compare Quality Of Recovery Score 40

•      Secondary Objectives are to compare:

–     Total consumption of analgesia in first 24hrs in postoperative period

–     VAS score in first 24 hrs

MATERIAL AND METHODS

Study setting :

Department of Anaesthesiology, King Georges Medical University, Lucknow.

Study duration : One year 

Study design: Randomized control double blind study

After getting approval from institutional ethical committee, this prospective study would be carried out in department of  Anaesthesiology, King George’s Medical University, Lucknow.

Sample size: 90 cases included in the study.

Sample size is calculated on the basis of variation in QoR-40 in the study group using the formula :

Where s = 4.1, The half IQR of QoR-40 in one of the study groups

d = 0.2 times median QoR-40  (=162.5), the minimum mean difference consider to be clinically significant.

(Ref. Mathew et. al.)^[15]

type I error α = 5% corresponding to 95% confidence level

type II error β = 10% for detecting results with 90% power of study

Loss to follow up = 10%

So the required minimum sample size

n = 28(each group)

Inclusion Criteria :

â–ª         Age 18-70 years

â–ª         ASA grade 1 and  2

â–ª         Patient giving written informed consent

â–ª         Female

â–ª         unilateral modified radical mastectomy for breast cancer

Exclusion criteria:

●      Endocrine disorders (including I and II type of Diabetes mellitus),

●      Allergies to local anesthetics

Study procedure:

 Patients will be randomly allocated to one of the following three groups using computer generated random numbers.

Group-I  - PECS block 20 ml 0.25% bupivacaine

Group-II  - Erecter spinae block 20 ml 0.25% bupivacaine

Group III- Control Group

Patient will be clinically examined in detail and all patients will undergo investigations like Complete haemogram, Blood sugar level, Renal function test, Liver function test and Electrocardiogram. After taking  the patient  in operation theatre monitors will be attached .Patient will be monitored for heart rate, SpO2, ECG. After thatIntravenous line will be taken and an intravenous fluid  will be  started and continued throughout the procedure. . Preoxygenation will be done for 3 mins and after that patient will be induced with injection fentanyl 1ug/kg, injection propofol 2mg /kg and after confirming adequate bag and mask ventilation injection vecuronium 0.1mg/kg will be given.Then after three minutes either  second generation supraglottic airway device or endotracheal tube will be inserted. After confirmation of adequate ventilation by auscultation and capnography patient will be put on volume controlled ventilation  mode. After that patient will receive respective block according to randomization in computer generated random number table.

Group I  will receive PECS block 

Group II will receive ESP block

GROUP III will be control group 

This study  will be double blinded as patient will not be aware of  intervention which they have received as well as  the observer who will observe the patient and collect data will not be aware of what intervention each patient has received.

Postoperative analgesia – PCM 1gm IV QID

Rescue analgesic – Inj. Tramadol 100mg IV (1-2mg/kg) .

The following parameters will be  studied

·        Hemodynamic variables pulse rate , blood pressure (NIBP),SpO₂ will be recorded before surgery and thereafter at every 15 minutes.

·        VAS Score will be observed before surgery and then immediately after extubation and then at  1hr,2hr,4hr,6hr,12hr,24hrs

·        Total consumption of rescue analgesia in 1^st 24 hrs

·        Quality of Recovery( QoR-40)  score at 24hrs

REVIEW OF LITERATURE

 Myles PS et al (2000) observed that Quality of recovery after anaesthesia is an important measure of the early postoperative health status of patients. They attempted to develop a valid, reliable and responsive measure of quality of recovery after anaesthesia and surgery. They studied 160 patients and asked them to rate postoperative recovery using three methods: a 100-mm visual analogue scale (VAS), a nine-item questionnaire and a 50-item questionnaire; the questionnaires were repeated later on the same day. From these results, we developed a 40-item questionnaire as a measure of quality of recovery (QoR-40; maximum score 200). They found good convergent validity between QoR-40 and VAS (r = 0.68, P < 0.001). Construct validity was supported by a negative correlation with duration of hospital stay (rho = -0.24, P < 0.001) and a lower mean QoR-40 score in women (162 (SD 26)) compared with men (173 (17)) (P = 0.002). There was also good test-retest reliability (intra-class ri = 0.92, P < 0.001), internal consistency (Cronbach’s alpha = 0.93, P < 0.001) and split-half coefficient (alpha = 0.83, P < 0.001). The standardized response mean, a measure of responsiveness, was 0.65. The QoR-40 was completed in less than 6.3 (4.9) min.It was believed that the QoR-40 is a good objective measure of quality of recovery after anaesthesia and surgery. It would be a useful end-point in perioperative clinical studies.

Gurkan et al (2018) did a  Randomized controlled, single-blinded trial to evaluate the analgesic effect of ultrasound-guided erector spinae plane (ESP) block in breast cancer surgery .Fifty ASA I–II patients aged 25–65 and scheduled for elective breast cancer surgery were included in the study.Patients were randomized into two groups, ESP and control. Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4 vertebral level was performed preoperatively to all patients in the ESP group. The control group received no intervention. Patients in both groups were provided with intravenous patient controlled analgesia device containing morphine for post operative analgesia.Morphine consumption and numeric rating scale (NRS) pain scores were recorded at 1, 6, 12 and 24 hrs post operatively.Morphine consumption at postoperative hours 1, 6, 12 and 24 decreased significantly in the ESP group (p < 0.05 for each time interval). Total morphine consumption decreased by 65% at 24 h compared to the control group (5.76 ± 3.8 mg vs 16.6 ± 6.92 mg). There was no statistically significant difference between the groups in terms of NRS scores. Findings show that US-guided ESP block exhibits a significant analgesic effect in patients undergoing breast cancer surgery.

Kamiya Yet al (2018) conducted a study to evaluate the ability of PECS block to decrease postoperative pain and anaesthesia and analgesia requirements and to improve postoperative QoR in patients undergoing breast cancer surgery. Randomised controlled study. A tertiary hospital. Sixty women undergoing breast cancer surgery between April 2014 and February 2015. The patients were randomised to receive a PECS block consisting of 30 ml of levobupivacaine 0.25% after induction of anaesthesia (PECS group) or a saline mock block (control group). The patients answered a 40-item QoR questionnaire (QoR-40) before and 1 day after breast cancer surgery. Numeric Rating Scale score for postoperative pain, requirement for intra-operative propofol and remifentanil, and QoR-40 score on postoperative day 1. PECS block combined with propofol-remifentanil anaesthesia significantly improved the median [interquartile range] pain score at 6 h postoperatively (PECS group 1 [0 to 2] vs. Control group 1 [0.25 to 2.75]; P = 0.018]. PECS block also reduced propofol mean (± SD) estimated target blood concentration to maintain bispectral index (BIS) between 40 and 50 (PECS group 2.65 (± 0.52) vs. Control group 3.08 (± 0.41) μg ml; P < 0.001) but not remifentanil consumption (PECS group 10.5 (± 4.28) vs. Control group 10.4 (± 4.68) μg kg h; P = 0.95). PECS block did not improve the QoR-40 score on postoperative day 1 (PECS group 182 [176 to 189] vs. Control group 174.5 [157.75 to 175]). In patients undergoing breast cancer surgery, PECS block combined with general anaesthesia reduced the requirement for propofol but not that for remifentanil, due to the inability of the PECS block to reach the internal mammary area. Further, PECS block improved postoperative pain but not the postoperative QoR-40 score due to the factors that cannot be measured by analgesia immediately after surgery, such as rebound pain.

Sinha et al (2019) conducted a study Sixty four American Society of Anesthesiologists’ status I and II female patients between age 18 to 60 years scheduled for unilateral modified radical mastectomy (MRM) under general anaesthesia, were enrolled in this prospective randomised study. Patients in group I received ultrasound guided (USG) ESP block (20 cc 0.2% ropivacaine) while group II received USG guided PECS II block (25 cc 0.2% ropivacaine). General anaesthesia was administered in a standardised manner to both the groups. The various parameters observed included sensory blockade, duration of analgesia and any adverse effects. The primary outcome was the total morphine consumption in 24 hours.  The total morphine consumption in 24 hours was less in group II (4.40 ± 0.94 mg), compared to group I (6.59 ± 1.35 mg; P = 0.000). The mean duration of analgesia in patients of group II was 7.26 ± 0.69 hours while that in the group I was 5.87 ± 1. 47 hours (P value = 0.001). 26 patients in group II (PECS) had blockade of T2 as compared to only 10 patients in group I. (P value = 0.00). There was no incidence of adverse effects in either group.  PECS II block is a more effective block when compared to ESP block in patients of MRM in terms of postoperative analgesia and opioid consumption.

Altıparmak B et al (2019) conducted a study that Single-blinded, prospective, randomized, efficacy study.Tertiary university hospital, postoperative recovery room and surgical ward.Forty patients (ASA I-II) were allocated to two groups. After exclusion, 38 patients were included in the final analysis (18 patients in the PECS groups and 20 in the ESP group).Modified pectoral nerve block was performed in the PECS group and erector spinae plane block was performed in the ESP group.Postoperative tramadol consumption and pain scores were compared between the groups. Also, intraoperative fentanyl need was measured.Postoperative tramadol consumption was 132.78±22.44mg in PECS group and 196±27.03mg in ESP group (p=0.001). NRS scores at the 15th and 30^thmin were similar between the groups. However, median NRS scores were significantly lower in PECS group at the postoperative 60^thmin, 120thmin, 12^thhour and 24^th hour (p = 0.024, p=0.018, p=0.021 and p=0.011 respectively). Intraoperative fentanyl need was 75 mg in PECS group and 87.5mg in ESP group. The difference was not statistically significant (p=0.263).Modified PECS block reduced postoperative tramadol consumption and pain scores more effectively than ESP block after radical mastectomy surgery.

References

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3.      Arsalani-Zadeh R, Elfadl D, Yassin N, et al. Evidence-based review of enhancing postoperative recovery after breast surgery. Br J Surg 2011;98:181–96.

4.      Dualé C, Gayraud G, Taheri H, Bastien O, Schoeffler P. A French nationwide survey on anesthesiologist-perceived barriers to the use of epidural and paravertebral block in thoracic surgery. J Cardiothorac Vasc Anesth2014;S1053077014005448.

5.      Blanco R. The ‘pecs block’: a novel technique for providing analgesia after breast surgery. Anaesthesia2011;66:847–8.

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14. Altıparmak B, Korkmaz Toker M, Uysal AÄ°, Turan M, Gümüş Demirbilek S Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65.

15.                      Mathew P, Aggarwal N, Kumari K, Gupta A, Panda N, Bagga R. Quality of recovery and analgesia after total abdominal hysterectomy under general anesthesia: A randomized controlled trial of TAP block vs epidural analgesia vs parenteral medications. J Anaesthesiol Clin Pharmacol 2019;35:170-5