SUBMITTED 15 APR 22 1 REVISION REQ. 15 JUN 22; REVISION RECD. 25 JUL 22 2 ACCEPTED 7 SEP 22 3 ONLINE-FIRST: September 2022 4 DOI: https://doi.org/10.18295/squmj.9.2022.057 5 6 Effect of Erector Spinae Block and PECS Block on Quality of Recovery 7 and Analgesia After Modified Radical Mastectomy 8 A randomised controlled study 9 Md Hammad Mohsin,1 *Reetu Verma,2 Hemlata,2 Dinesh Singh,2 Sarita 10 Singh,2 Kulranjan Singh3 11 12 1Department of Anaesthesiology, All India Institute of Medical Sciences, Patna, India; 13 Departments of 2Anaesthesiology and 3Endocrine Surgery, King George's Medical University, 14 Lucknow, India. 15 *Corresponding Author’s e-mail: reetuverma1998@gmail.com 16 17 Abstract 18 Objectives: Postoperative pain after modified radical mastectomy ranges from moderate to 19 severe. Pectoralis block in comparison to Erector Spinae block have been found better in 20 reducing pain scores and reducing consumption of rescue analgesic in postoperative period. 21 This study aimed to compare the effect of Erector Spinae block and Pectoralis block on 22 quality of recovery after Modified Radical Mastectomy using QoR-40 score. Methods: After 23 general anaesthesia, patients were given block according to computer generated 24 randomization. Group-I-Pectoralis block including PEC I AND PEC II(PECS), Group-II-25 Erector spinae block(ESP) and Group III-Control Group (No intervention). Quality of 26 recovery (QoR-40) score was observed on morning of surgery and at 24 hrs. Time to rescue 27 analgesia and total consumption of rescue analgesia in first 24 hrs. were also observed. 28 Results: In the postoperative period at 24 hrs. Global QoR-40 scores were 183.64±6.36 in 29 PECS group, 179.68± 6.38 in ESP group and 171.37±6.88 in control group. (p<0.0001) But, 30 there was no statistically significant difference between QoR score of PECS & ESP group 31 patients(p=0.0551). The total requirement of rescue analgesic was significantly lesser in 32 PECS group (137.28±31.46 mg) in comparison to ESP Group(189.46±42.98mg) and control 33 mailto:reetuverma1998@gmail.com group (229.57±46.80 mg). (p<0.0001). Time to first rescue analgesia was significantly higher 34 in PECS group (6.53±2.78 hrs) in comparison to ESP (4.05±2.91 hrs) and control group 35 (2.15±1.51 hrs). (p<0.0001) Conclusion: Both Erector Spinae block and Pectoralis block are 36 effective for improving QoR score and reducing consumption of rescue analgesic after 37 modified radical mastectomy. 38 Keywords: breast surgery, cancer, postoperative recovery, postoperative pain 39 40 Advances in Knowledge 41 Both Erector Spinae Block and PECS block have been shown very promising 42 results in providing postoperative analgesia after breast surgery. Our study based 43 on these blocks helped us to get more data and knowledge as well as getting 44 accustomed about these blocks. 45 46 Application to Patient Care 47 These blocks providing post-operative analgesia resulted in patients being more 48 comfortable post operatively, having a better feel of general over all wellbeing as 49 well as better post operative outcomes. 50 51 Introduction 52 In year 2020 female breast cancer was diagnosed as most common cancer worldwide.1,2 53 Radical or Modified Radical Mastectomy (MRM) is main treatment option for locally 54 advanced lesions of breast.3 MRM is usually done under general anaesthesia. Incidence 55 of severe post-operative pain on the first post-operative day after MRM has been 56 reported to be 60%.4 Poor management of pain in the postoperative period may produce 57 various acute and chronic detrimental effects.5,6 So, adequate control of pain in 58 postoperative period is very important to alleviate these detrimental effects. Also, getting 59 adequate pain management is fundamental right of every patient. 7 Moreover, adequate 60 control of pain in postoperative period can also have an impact on quality of recovery of 61 patients.8 QoR-40 score is a global score for assessing the status of recovery after 62 anaesthesia and surgery. It includes 40 questions covering five domains: patient’s 63 psychological support, emotional status, physical comfort, physical independence in 64 doing his work and severity of pain. In a number of surgical settings, the QoR-40 score 65 has been shown to be a valid, and sensitive method, for measuring the dynamic and 66 multidimensional process of post-operative recovery.9-11 Nair et al., in their study found 67 that patients who received regional blocks during breast surgery had higher 68 postoperative QoR scores.11 Yao Y et al. also observed that preoperative ESP block 69 improves postoperative QoR score and postoperative analgesia in patients undergoing 70 MRM.12 Sinha C et al compared PECS block and ESP after MRM and observed that 71 PECS block patients had lower pain scores and consumptions of analgesics in the 72 postoperative period in comparison to ESP block.13 So we hypothesized that PECS 73 block patient would also have better quality of recovery in comparison to ESP, and this 74 study was done to compare the effect of ESP block and PECS block on post-operative 75 quality of recovery after MRM using QoR-40 score. The primary objective of the study 76 was to compare the Quality of Recovery Score (QoR-40) at 24 hrs. after surgery. The 77 secondary objectives were total consumption of analgesics in the first 24hrs, time to 78 rescue analgesia, postoperative VAS score and to compare intraoperative hemodynamic. 79 80 Methods 81 This randomized control study was conducted adhering to the Helsinki declaration, 82 CONSORT recommendations for RCT from 20/12/2020 to 20/12/2021 after approval from 83 the institutional ethical committee (***) and after clinical trial registry (***) in department of 84 anaesthesia. 85 86 This study included patients between 18-60 years female with ASA grade I &II, who 87 were planned for unilateral modified radical mastectomy for breast cancer. Written 88 informed consent was obtained from all patients. Exclusion criteria were patient refusal, 89 endocrine disorders (including I and II type of Diabetes Mellitus), any coagulation 90 disorders, cognitive inability to understand QoR-40 questionnaire and allergies to local 91 anaesthetics. 105 patients were assessed for eligibility. (Figure 1) Patients were 92 randomly allocated to one of the following three groups using computer-generated 93 random numbers. Group-I-Pectoralis block (PECS block), Group-II-Erector spinae block 94 (ESP block) & Group III-Control Group. QoR-40 score was noted on the morning of 95 surgery in each patient. After taking the patients in operation theatre, monitors were 96 attached. The patients were monitored for heart rate, BP (SBP, DBP & MAP), SpO2, and 97 ECG. After that intravenous line was taken in arm contralateral to surgery planned and 98 an intravenous fluid was started. Preoxygenation was done for 3 mins and after that 99 patient were induced with injection fentanyl 1ug/kg, injection propofol 2-2.5 mg/kg and 100 after confirming adequate bag and mask ventilation injection vecuronium 0.1mg/kg was 101 given. After three minutes, either second generation supraglottic airway device or 102 endotracheal tube was inserted. After confirmation of adequate ventilation by 103 auscultation and capnography patients were put on volume-controlled ventilation mode. 104 Anaesthesia was maintained with O2: N20(50:50) and sevoflurane. After that patient 105 received respective block according to randomization. 106 107 The blocks were performed with Stimuplex® needle A100 (0.80 x 100mm (21G x 4”) 108 and Toshiba USG machine with a high frequency linear probe 38mm, 6-13 MHz. Hydro 109 dissection (saline) was used to identify the correct position and plane before injecting the 110 local anesthetic. 111 Pectoralis Block 112 The patient was positioned supine, with the arm ipsilateral to surgery site abducted to 90 113 degrees. The skin was prepared with 10% betadine solution. The sterile USG probe was 114 put longitudinally at the mid clavicular level just below clavicle and was adjusted to 115 identify axillary artery and vein. After that caudal edge of probe was turned laterally and 116 USG probe was moved downwards to identify third rib, fourth rib, pectoralis major 117 muscle, pectoralis minor muscle and serratus anterior muscle. The needle was introduced 118 through an in-plane technique from cranial edge of probe and advances to lie in 119 interfascial plane between pectoralis minor and serratus anterior muscle and 20 ml of 120 .25% bupivacaine was administered (PECS II). After giving PECS II block, the needle 121 was withdrawn slowly and adjusted to lie between pectoralis major and minor muscle 122 and after confirmation by hydro dissection, 10 ml of 0.25% bupivacaine was deposited 123 there (PECS I). 124 125 Erector Spinae Block 126 The patient was placed in lateral decubitus position and, following aseptic precautions, 127 sterile USG probe was put longitudinally paramedian to thoracic spine and T4 transverse 128 process was identified. Superficial to transverse process erector spinae, rhomboid major 129 and trapezius muscles were identified. The needle was introduced through an in-plane 130 cephalocaudal approach till the needle tip contacts the transverse process and after 131 confirmation of correct plane by hydro dissection 20ml of 0.25% bupivacaine was given 132 superficial to the transverse process and beneath the erector spinae muscle. 133 134 This study was double blinded as the patients were not aware of the intervention, they had 135 received and the observer who observed the patient and collected data was also not aware of 136 intervention each patient has received. 30 minutes before completion of surgery each patient 137 was given PCM 1gm i.v. and thereafter 1gm i.v. at every 6 hours. If any patient had VAS 138 score > 3 in postoperative period, rescue analgesic injection of Tramadol (100mg) i.v. was 139 given. Time duration between two injection of tramadol was kept >4 hrs. Hemodynamic 140 variables (Heart Rate, MAP, SBP, DBP, & SPO2) were recorded before surgery and after that 141 every 15 minutes till completion of surgery. Time to rescue analgesia and total consumption 142 of rescue analgesia in 1st 24 hrs. were also observed. Quality of recovery (QoR-40) score was 143 observed again at 24 hrs. QoR-40 questionnaires were filled by observer who verbally 144 translated the questionnaire to patients into the regional language. 145 146 Statistical analysis 147 Sample size is calculated on the basis of pilot study done on 10 patients in which SD was 148 7.12 for QoR-40 in control group. Assuming a difference of 10 would be clinically 149 significant, minimum sample size was calculated to be 28 in each group. We took 30 patients 150 in each group with the possibility of loss to follow up. Statistical analysis was performed 151 using SPSS software (15.0 version). The continuous variables were evaluated by mean and 152 standard deviation.. The dichotomous variables were presented in number and were analysed 153 using Chi-square or Fisher Extract test. To compare the means between the two groups, 154 Student t-test and for comparing three groups ANOVA tests were used. A p-value of < 0.05 155 was regarded as significant. 156 157 Results 158 In our study all groups had comparable demographic profile. (Table No.1) On 159 comparing mean average global QoR-40(0-200) score preoperatively, there was no 160 statistically significant difference between three groups (p =0.8360). At 24 hrs there 161 was a significant difference between three groups. In our study at 24 hours, Global 162 QoR-40(0-200) score was highest in PECS group followed by Erector Spinae group 163 and control group patients. The difference between three groups were statistically 164 significant(p<0.0001). But difference between PECS & Erector Spinae group patients 165 was not significant statistically(P=0.0551). (Table No.2) 166 167 The requirement of rescue analgesic was significantly lower in PECS group in comparison to 168 Erector Spinae Group and Control group patients(p<0.0001). Time to first rescue analgesic 169 was significantly higher in PECS group in comparison to other two groups. (Table 3) 170 The gradual increase in VAS score was observed in all the three groups after surgery. VAS 171 score was lowest in PECS group. The difference between groups was statistically significant 172 at 6 hours, 12 hours and 24 hours. (Table-4) 173 174 There was no clinically significant difference between haemodynamic in three groups 175 intraoperatively. (Fig 2,3) 176 177 Discussion 178 After MRM, patients report moderate to severe postoperative pain and various drugs and 179 regional analgesic techniques are being used for providing postoperative pain relief. Opioids 180 are the drugs which are most commonly used for providing postoperative analgesia but using 181 opioid in cancer patients is related to suppression of cellular immunity and increase in cancer 182 recurrence.14 NSAIDs are the other class of drugs which are also commonly used for 183 postoperative analgesia but their efficacy is limited to mild to moderate pain. Also, patients 184 with MRM has high incidence of postoperative nausea and vomiting and using opioids and 185 NSAIDs may increase the incidence of PONV.15 Transdermal patch is a non-invasive 186 method of providing postoperative analgesia and they have been found very effective in 187 reducing pain scores in postoperative period in various other surgeries. But transdermal 188 patches generally contain opioids and NSAIDs which can again increase the incidence of 189 nausea and vomiting after MRM surgery. So, regional analgesia is best modality for 190 providing postoperative analgesia in MRM patients. Further, it has also been found that using 191 regional analgesia also decreases the incidence of chronic pain. 16 192 193 Among, regional analgesia thoracic epidural and paravertebral blocks are still gold 194 standard analgesic techniques.17-19 But, sometimes it may be difficult to give thoracic 195 epidural and paravertebral block and they are also associated with complications such 196 as pneumothorax, vascular puncture, or nerve injury. So, there is always a need to find 197 alternatives to these blocks, which are easy to give, having a higher safety profile and 198 can provide equivalent pain relief. Both PECS block and ESP block are blocks which 199 are easy to perform and with very less complications in expert hands. They also reduce 200 the requirement of analgesia in postoperative period with decrease in pain scores. 20,21 201 202 Quality of recovery of any patient after surgery may be related to quality of 203 perioperative analgesia. Myles PS et al in their study observed that patient’s quality of 204 recovery after anaesthesia and surgery can be assessed effectively by using QoR-40 205 score.10 206 207 In our study at 24 hours, the Global QoR-40 score was 183.64±6.36 in PECS group, 179.68± 208 6.38 in ESP group, and 171.37±6.88 in control group and the inter mean difference between 209 groups was statistically significant at 24 hours global QoR-40(0-200) (p<0.0001). However, 210 the difference between PECS group and ESP group was statistically insignificant. Kamiya Y 211 et al studied the effect of PECS block on postoperative pain and QoR score in breast cancer 212 surgery patients and observed that pain score in PECS group was lower than control group 213 till 24 hrs. 22 But there was no statistically significant difference between requirement of 214 rescue analgesic and QoR-40 score in their study. In our study, we reported a significant 215 difference between PECS and control group in requirement of rescue analgesic and QoR 216 score. It may be because of that for PECS II block Kamiya Y,. et al injected the drug deep to 217 serratus anterior muscle and in our study drug was administered superficial to serratus 218 anterior muscle. 219 220 In a study conducted by Yao Y et al,. it was also found that ESP block improves pain score 221 QoR score in the postoperative period.12 222 223 Similar to our study Sinha et al,. also observed that PECS block administered prior to MRM 224 leads to decreased requirement of postoperative analgesics in first 24 hours. The mean 225 duration of analgesia was 7.26 ±0. 69 hrs in patients with PECS block and 5.87 ±1.47 hrs in 226 individuals with ESP block.13 227 228 Similar to our study Altiparmak B et al, also observed that PECS group patients had lower 229 consumption of tramadol in postoperative period. In their study consumption of tramadol was 230 132.78 ± 22.44 mg in PECS group and 196 ± 27.03 mg in ESP group (p = 0.001).23 231 232 Gad M et al also observed that patients in PECS group had lower consumption of morphine 233 in postoperative period in comparison to ESP block patients.24 234 235 Regarding complications, we have not encountered any procedure related complications in 236 any of group which is similar to other studies. 237 238 The limitation of our study is that we used original version of QoR-40 score which is in 239 English and score was filled by clinician verbally translating it into regional language. So it 240 might have affected the interpretation of score. Other limitations of our study were its small 241 sample size and single-centric approach. Another limitation was that the block was given 242 after inducing the patients so we could not access the level of sensory block. 243 244 Conclusion 245 To conclude, both Erector Spinae and Pectoralis blocks in comparison to control group are 246 effective for improving postoperative quality of recovery after modified radical mastectomy. 247 But, in Pectoralis blocks group time to first rescue analgesic was higher and requirement of 248 rescue analgesic was lesser in comparison to Erector Spinae Block. As our study is single 249 centred, a multicentric study with large sample size is required for generalizability of results. 250 251 Conflicts of Interest 252 The authors declare no conflict of interests. 253 254 Funding 255 No funding was received for this study. 256 257 Author Contributions 258 Collection of data and drafting the manuscript was done by MHM. Analysis and 259 interpretation of data were handled by MHM and RV. 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Anesth Essays Res. 2019;13(2):334-339. 333 334 Figure 1: Consort flow chart 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 Assessed for eligibility (n= 105 ) Randomized(n=90) Excluded(n=15) Not meeting exclusion criteria(n=10) Declined to participate(n=5) Allocated to PECS Block(n= 30 ) Received PECS Block (n= 30 ) Did not receive PECS Block (n= 0) Allocated to Erector Spinae Block(n= 30 ) Received Erector Spinae block (n= 30 ) Did not receive Erector Spinae Block (n= 0 ) Lost to follow-up (n= 0) Discontinued intervention (n= 0 ) Lost to follow-up (n= 0) Discontinued intervention (n= 0 ) Analysed (n= 30 ) Excluded from analysis (n= 0 ) Allocated to control group (n= 30 No intervention (Control Group) (n= 30 ) Analysed (n= 30 ) Excluded from analysis (n= 0 ) Lost to follow-up (n= 0) Analysed (n= 30 ) Excluded from analysis (n= 0 ) Table 1: Demographic Profiles 369 Group-I(PECS group) [n=30] Group-II(ESP group) [n=30] Group- III(Control Group) [n=30] p-value Age(in years) 43.52±9.6 42.26±7.64 44.13±8.9 F=0.3563 p=0.7013# Weight (in kg) 59.4±9.1 57.2±5.28 56.71±8.1 F=1.048 p=0.3551# Height (in cms) 162.6±7.6 159.0±46.5 156.21±3.9 F=0.4132 p=0.66283# BMI(kg/m2) 22.5±3.8 23.9±3.6 22.0±3.1 F=1.118 p=0.21963# ASA I:II 24:6 26:4 25:5 X=0.48 p=0.7866# Duration of Anaesthesia(in minutes) 86.8±18.1 89.4±19.4 87.7±17.5 F=0.1553 p=0.8564# *p value< 0.05= significant, #p value> 0.05= non-significant 370 371 Table 2: Tabular presentation of mean global QoR-40(0-200) of Group-I, Group-II and 372 Group-III patients 373 Global QoR-40 (0-200) Group-I(PECS group) [n=30] Group-II(ESP group) [n=30] Group- III(Control Group) [n=30] p-value Pre-OP 186.63±7.78 185.53±6.73 186.34±7.56 F=0.1795 p=0.8360 ¥p=0.8322, €p=0.9873,£p=0.9051 At 24 hrs 183.64±6.36 179.68± 6.38 171.37±6.88 F=27.47 p<0.0001* ¥p=0.0551,€p<0.0001*,£p<0.0001* *p value< 0.05= significant, #p value> 0.05= non-significant 374 ¥Group-I Vs Group-II, € Group-I Vs Group-III, £ Group-II Vs Group-III 375 376 377 378 379 380 381 382 383 Table 3: Time to first rescue analgesic requirement and total rescue analgesic in first 24 hrs 384 Group- I(PECS group) [n=30] Group-II(ESP group) [n=30] Group- III(Control Group) [n=30] p-value Time to first rescue analgesics requirement(hrs) 6.53±2.78 4.05±2.91 2.15±1.51 F=23.5 p<0.0001* ¥p=0.0006*,€p<0.0001*,£p=0.0108* Total rescue analgesics requirement (in mg) in first 24 hrs 137.28±31.46 189.46±42.98 229.57±46.80 F=38.34 p<0.0001* ¥p<0.0001*,€p<0.0001*,£p=0.0008* *p value< 0.05= significant, #p value> 0.05= non-significant, 385 ¥Group-I Vs Group-II, € Group-I Vs Group-III, £ Group-II Vs Group-III 386 387 Table 4: Tabular presentation of mean VAS score of Group-I, Group-II and Group-III 388 patients 389 VAS Score Group- I(PECS group) [n=30] Group- II(ESP group) [n=30] Group- III(Control Group) [n=30] p-value At 1 Hour 0±0 0±0 0±0 --- At 2 Hour 0±0 0±0 0±0 --- At 4 Hour 0.52±0.37 0.54±0.82 0.59±0.21 F=0.1371 P=0.8721 At 6 Hour 1.04±0.19 2.01±0.54 4.13±1.45 F=92.48 P<0.0001* At 12 Hour 1.44±0.54 2.28±0.90 4.80±1.09 F=120.2 P<0.0001* At 24 Hour 2.10±1.14 3.41±1.19 4.94±1.95 F=27.9 P<0.0001* *p value< 0.05= significant, #p value> 0.05= non-significant, 390 ¥Group-I Vs Group-II, € Group-I Vs Group-III, £ Group-II Vs Group-III 391 392 393 394 395 396 397 398 399 Figure 2: Mean Pulse Rate in beats per minute between three groups 400 401 402 Figure 3: Mean Arterial Pressure in mm of Hg between three groups 403