To compare effect of erector spinae block and pecs block on recovery and pain after modified radical mastectomy

Phase 4

Not yet recruiting

• Conditions: Disorder of breast, unspecified,

• Registration Number: CTRI/2020/12/029933
• Lead Sponsor: King Georges Medical University

Brief Summary

**INTRODUCTION**

Breast cancer is the most commonmalignancy in women; surgery is one of the mainstays of treatment of breastcancer, and modified radical mastectomy is one of the standard treatments.[[1](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6504333/#R1)–[3](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6504333/#R3)] Postoperativepain can seriously reduce the quality of life in patients, and acute pain caneven trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural,intercostal nerve, and interscalene brachial plexus blocks have been used foranesthesia and analgesia during modified radical mastectomy, but theirapplications are limited by the complicated nature of the procedures and severecomplications.[[1](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6504333/#R1)–[4](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6504333/#R4)]

In recent years, there has beenincreasing interest on a novel, less invasive nerve block, the pectoral nerve(PECS) block. PECS I block is an interfascial plane block administered betweenthe pectoralis major and the pectoralis minor muscles.  The Pecs I block is a single injection oflocal anaesthetic between pectoralis major and pectoralis minor muscles at thelevel 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 submuscularprostheses, portacaths and implantable cardiac defibrillators/pacemakers,anterior thoracotomies and shoulder surgery involving the deltopectoralgroove.The PECS II block includes the PECS I block combined with a blockadministered above the serratus anterior muscle at the third rib.[[5](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6504333/#R5),[6](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6504333/#R6)]ThePecs II block is a modified Pecs I block and can be achieved with one needleinsertion point.Local anaesthetic is placed between pectorals major and minoras in Pecs I block and then between pectoralis minor and serratus anteriormuscles. 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 theaxilla. On its medial side it attaches to the lateral side of the pectoralmuscle. This second injection will anaesthetise the anteriocutaneous branchesof the intercostal nerves, the intercostobrachialis and the long thoracicnerves. Indications are similar to Pecs I with some additions: tumourresections, mastectomies, sentinel node biopsies.The Pecs II block (which alsoincludes the Pecs I block) is an extension that involves a second injectionlateral to the Pecs I injection point in the plane between the pectoralis minorand serratus anterior muscles with the intention of providing blockade of theupper intercostal nerves.

[Kamiya Y](https://www.ncbi.nlm.nih.gov/pubmed/?term=Kamiya%20Y%5BAuthor%5D&cauthor=true&cauthor_uid=29227351)et al observed the ability of PECSblock to decrease postoperative pain and anaesthesia and analgesia requirementsand to improve postoperative Quality of Recovery( QoR) in patients undergoing breast cancer surgery.[7]

Erector spinae plane (ESP) block is oneof the newer interfascial techniques with potential applications.  ESP block is an interfascial block that canbe performed by superficial or deep needle approach. In superficial needleapproach technique, drug is injected between rhomboid major muscle and erectorspinae muscle, whereas in the deep needle approach, drug is injected belowerector spinae muscle. [8]

Gurkan Y et al observed that ultrasound guidederector spinae plane block reduces postoperative opioid consumption  following breast surgery. [9]

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

             **AIM AND OBJECTIVES**

**AIM-** Theaim of study is to compare the efficacy of PECS block and ERECTOR spinae blockfor postoperative quality of recovery and analgesia after Modified RadicalMastectomy

**OBJECTIVE**

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

•      Secondary Objectives are to compare:

–     Total consumption of analgesia infirst 24hrs in postoperative period

–     VAS score in first 24 hrs

  **MATERIALAND METHODS**

**Study setting :**

Departmentof 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 MedicalUniversity, Lucknow.

**Sample size:** 90 cases included in the study.

Sample size is calculated on the basis ofvariation 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 considerto 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:**

â—     Endocrine disorders (including I and II type ofDiabetes mellitus),

â—     Allergies to local anesthetics

 **Study procedure:**

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

Group-I  - PECS block20 ml 0.25% bupivacaine

Group-II  - Erecterspinae block 20 ml 0.25% bupivacaine

Group III- Control Group

Patient will be clinically examinedin detail and all patients will undergo investigations like Complete haemogram,Blood sugar level, Renal function test, Liver function test andElectrocardiogram. Aftertaking  the patient  in operation theatre monitors will be attached.Patient will be monitored for heart rate, SpO2, ECG. After thatIntravenousline will be taken and an intravenous fluid  will be started and continued throughout the procedure. . Preoxygenation will be done for3 mins and after that patient will be induced with injection fentanyl 1ug/kg,injection propofol 2mg /kg and after confirming adequate bag and mask ventilationinjection vecuronium 0.1mg/kg will be given.Then after three minutes either  second generation supraglottic airway deviceor endotracheal tube will be inserted. After confirmation of adequateventilation by auscultation and capnography patient will be put on volumecontrolled ventilation  mode. After thatpatient will receive respective block according to randomization in computer generatedrandom number table.

GroupI  will receive PECS block

GroupII will receive ESP block

GROUPIII will be control group

Thisstudy  will be double blinded as patientwill not be aware of  intervention whichthey have received as well as  theobserver who will observe the patient and collect data will not be aware ofwhat intervention each patient has received.

Postoperative analgesia – PCM 1gm IV QID

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

Thefollowing parameters will be  studied

·       Hemodynamic variablespulse rate , blood pressure (NIBP),SpO2 will be recorded beforesurgery and thereafter at every 15 minutes.

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

·       Total consumption ofrescue analgesia in 1st 24 hrs

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

   **REVIEW OF LITERATURE**

**Myles PS etal** **(2000)** observedthat Qualityof recovery after anaesthesia is an important measure of the early postoperativehealth status of patients. They attempted to develop a valid, reliable andresponsive measure of quality of recovery after anaesthesia and surgery. Theystudied 160 patients and asked them to rate postoperative recovery using threemethods: a 100-mm visual analogue scale (VAS), a nine-item questionnaire and a50-item questionnaire; the questionnaires were repeated later on the same day.From these results, we developed a 40-item questionnaire as a measure ofquality of recovery (QoR-40; maximum score 200). They found good convergentvalidity between QoR-40 and VAS (r = 0.68, P < 0.001). Construct validitywas 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-retestreliability (intra-class ri = 0.92, P < 0.001), internal consistency (Cronbach’salpha = 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 theQoR-40 is a good objective measure of quality of recovery after anaesthesia andsurgery. It would be a useful end-point in perioperative clinical studies.

**Gurkan et al(2018)** dida  Randomized controlled, single-blindedtrial to evaluate the analgesic effect of ultrasound-guided erector spinaeplane (ESP) block in breast cancer surgery .Fifty ASA I–II patients aged25–65 and scheduled for elective breast cancer surgery were included in thestudy.Patients were randomized into two groups, ESP and control. Single-shotultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4vertebral level was performed preoperatively to all patients in the ESP group.The control group received no intervention. Patients in both groups wereprovided with intravenouspatient controlled analgesia devicecontaining morphine for post operative analgesia.Morphine consumption and numericrating scale (NRS) pain scores were recorded at 1, 6, 12 and 24 hrs postoperatively.Morphine consumption at postoperative hours 1, 6, 12 and 24decreased significantly in the ESP group (p < 0.05 for each time interval).Total morphine consumption decreased by 65% at 24 h compared to the controlgroup (5.76 ± 3.8 mg vs 16.6 ± 6.92 mg). There was no statistically significantdifference between the groups in terms of NRS scores. Findings show thatUS-guided ESP block exhibits a significant analgesic effect in patientsundergoing breast cancer surgery.

[**Kamiya Y**](https://www.ncbi.nlm.nih.gov/pubmed/?term=Kamiya%20Y%5BAuthor%5D&cauthor=true&cauthor_uid=29227351)**et al (2018)** conducted a study to evaluate the ability of PECS block todecrease postoperative pain and anaesthesia and analgesia requirements and toimprove postoperative QoR in patients undergoing breast cancer surgery.Randomised controlled study. A tertiary hospital. Sixty women undergoing breastcancer surgery between April 2014 and February 2015. The patients wererandomised to receive a PECS block consisting of 30 ml of levobupivacaine 0.25% afterinduction of anaesthesia (PECS group) or a saline mock block (control group).The patients answered a 40-item QoR questionnaire (QoR-40) before and 1 dayafter breast cancer surgery. Numeric Rating Scale score for postoperative pain,requirement for intra-operative propofol and remifentanil, and QoR-40 score onpostoperative day 1. PECS block combined with propofol-remifentanil anaesthesiasignificantly improved the median [interquartile range] pain score at 6 h postoperatively (PECS group 1 [0to 2] vs. Control group 1 [0.25 to 2.75]; P = 0.018]. PECS block also reducedpropofol mean (± SD) estimated target blood concentration to maintainbispectral index (BIS) between 40 and 50 (PECS group 2.65 (± 0.52) vs. Controlgroup 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 improvethe 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 cancersurgery, PECS block combined with general anaesthesia reduced the requirementfor propofol but not that for remifentanil, due to the inability of the PECSblock to reach the internal mammary area. Further, PECS block improvedpostoperative pain but not the postoperative QoR-40 score due to the factorsthat cannot be measured by analgesia immediately after surgery, such as reboundpain.

**Sinha et al (2019)** conducted a study Sixty fourAmerican Society of Anesthesiologists’ status I and II female patients betweenage 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 toboth the groups. The various parameters observed included sensory blockade,duration of analgesia and any adverse effects. The primary outcome was thetotal morphine consumption in 24 hours.  The total morphine consumption in24 hours was less in group II (4.40 ± 0.94 mg), compared to group I (6.59 ±1.35 mg; *P* = 0.000). Themean duration of analgesia in patients of group II was 7.26 ± 0.69 hours whilethat 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 only10 patients in group I. (*P* value= 0.00). There was no incidence of adverse effects in either group.  PECSII block is a more effective block when compared to ESP block in patients ofMRM in terms of postoperative analgesia and opioid consumption.

[**Altıparmak B**](https://www.ncbi.nlm.nih.gov/pubmed/?term=Alt%C4%B1parmak%20B%5BAuthor%5D&cauthor=true&cauthor_uid=30396100) **et al (2019)**conducted a study that Single-blinded, prospective, randomized, efficacystudy.Tertiary university hospital, postoperative recovery room and surgicalward.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 groupsand 20 in the ESP group).Modified pectoral nerve block was performed in thePECS group and erector spinae plane block was performed in the ESPgroup.Postoperative tramadol consumption and pain scores were compared betweenthe groups. Also, intraoperative fentanyl need was measured.Postoperativetramadol consumption was 132.78±22.44mg in PECS group and 196±27.03mg in ESPgroup (p=0.001). NRS scores at the 15th and 30thmin were similarbetween the groups. However, median NRS scores were significantly lower in PECSgroup at the postoperative 60thmin, 120thmin, 12thhourand 24th hour (p = 0.024, p=0.018, p=0.021 and p=0.011respectively). Intraoperative fentanyl need was 75 mg in PECS group and 87.5mgin ESP group. The difference was not statistically significant (p=0.263).ModifiedPECS block reduced postoperative tramadol consumption and pain scores moreeffectively than ESP block after radical mastectomy surgery.

    **References**

1.     Organization, W.H., Global HealthEstimates. 2008.

2.     Dai X, Li T, Bai Z, et al. Breast cancerintrinsic subtype classification, clinical use and future trends. Am JCancer Res 2015;5:2929–43.

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

4.     Dualé C, Gayraud G, Taheri H, [Bastien O](https://www.ncbi.nlm.nih.gov/pubmed/?term=Bastien%20O%5BAuthor%5D&cauthor=true&cauthor_uid=25726182), [Schoeffler P](https://www.ncbi.nlm.nih.gov/pubmed/?term=Schoeffler%20P%5BAuthor%5D&cauthor=true&cauthor_uid=25726182). A Frenchnationwide survey on anesthesiologist-perceived barriers to the use of epiduraland paravertebral block in thoracic surgery. J Cardiothorac VascAnesth2014;S1053077014005448.

5.     Blanco R. The ‘pecs block’: a noveltechnique for providing analgesia after breastsurgery. Anaesthesia2011;66:847–8.

6.     Blanco R, Fajardo M, Parras MT. Ultrasounddescription of Pecs II (modified Pecs I): a novel approach to breastsurgery. Rev Esp Anestesiol Reanim 2012;59:470–5.

7.     Kamiya Y, Hasegawa M, Yoshida T, etal. Impact of pectoral nerve block on postoperative pain and quality ofrecovery in patients undergoing breast cancer surgery: A randomised controlledtrial. Eur J Anaesthesiol2017;35:1.

8.      Forero M, Adhikary SD, Lopez H, Tsul C, Chin KJ. Theerector spinae plane block: A novel analgesic technique in thoracic neuropathicpain. Reg Anaesth Pain Med 2016;41:621-7.

9.     Gürkan Y, Aksu C, KuÅŸ A, YörükoÄŸlu UH, Kılıç CT.Ultrasound guided erector spinae plane block reduces postoperative opioidconsumption following breast surgery: a randomized controlled study. J ClinAnesth. 2018;50:65–8..

10. Myles PS, Weitkamb B,Jones K, Melick J, Hensen S. Validity and reliability of a postoperativequality of recovery score: The QoR-40. Br J Anaesth 2000;84:11-5

11. Myles PS, Hunt JO,Fletcher H, Solly R. Relation between quality of recovery in hospital andquality of life at 3 months after cardiac surgery. Anesthesiology2001;95:862-7.

12. Leslie K, Troedel S,Irwin K, Pearce F, Ugoni A. Quality of recovery from anesthesia inneurosurgical patients. Anesthesiology 2003;99:1158-65.

13. Sinha C, Kumar A, KumarA, Prasad C, Singh PK, Priya D. Pectoral nerve versus erector spinae block forbreast surgeries: A randomised controlled trial. Indian J Anaesth2019;63:617-22

14. [AltıparmakB](https://www.ncbi.nlm.nih.gov/pubmed/?term=Alt%C4%B1parmak%20B%5BAuthor%5D&cauthor=true&cauthor_uid=30396100), [KorkmazToker M](https://www.ncbi.nlm.nih.gov/pubmed/?term=Korkmaz%20Toker%20M%5BAuthor%5D&cauthor=true&cauthor_uid=30396100), [UysalAÄ°](https://www.ncbi.nlm.nih.gov/pubmed/?term=Uysal%20A%C4%B0%5BAuthor%5D&cauthor=true&cauthor_uid=30396100), [TuranM](https://www.ncbi.nlm.nih.gov/pubmed/?term=Turan%20M%5BAuthor%5D&cauthor=true&cauthor_uid=30396100), [GümüşDemirbilek S](https://www.ncbi.nlm.nih.gov/pubmed/?term=G%C3%BCm%C3%BC%C5%9F%20Demirbilek%20S%5BAuthor%5D&cauthor=true&cauthor_uid=30396100) Comparison of theeffects of modified pectoral nerve block and erector spinae plane block onpostoperative opioid consumption and pain scores of patients after radicalmastectomy surgery: A prospective, randomized, controlled trial. [J Clin Anesth.](https://www.ncbi.nlm.nih.gov/pubmed/30396100 "Journal of clinical anesthesia.") 2019May;54:61-65.

15.                     Mathew P, Aggarwal N, Kumari K, Gupta A, PandaN, Bagga R. Quality of recovery and analgesia after total abdominalhysterectomy under general anesthesia: A randomized controlled trial of TAPblock vs epidural analgesia vs parenteral medications. J Anaesthesiol ClinPharmacol 2019;35:170-5

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-12-18
• Study Start: 2020-12-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Age 18-70 years ASA grade 1 and 2 Patient giving written informed consent Female unilateral modified radical mastectomy for breast cancer.

Exclusion Criteria

Endocrine disorders (including I and II type of Diabetes mellitus), Allergies to local anesthetics.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•VAS Score will be observed before surgery and then immediately after extubation and then at 1hr,2hr,4hr,6hr,12hr,24hrs	•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 1st 24 hrs | •Quality of Recovery( QoR-40) score at 24hrs
•Total consumption of rescue analgesia in 1st 24 hrs	•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 1st 24 hrs | •Quality of Recovery( QoR-40) score at 24hrs
•Quality of Recovery( QoR-40) score at 24hrs	•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 1st 24 hrs | •Quality of Recovery( QoR-40) score at 24hrs
•Hemodynamic variables pulse rate , blood pressure (NIBP),SpO2 will be recorded before surgery and thereafter at every 15 minutes.	•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 1st 24 hrs | •Quality of Recovery( QoR-40) score at 24hrs

Secondary Outcome Measures

Name	Time	Method
Total consumption of rescue analgesia in 1st 24 hrs	•Quality of Recovery( QoR-40) score at 24hrs

Trial Locations

Locations (1)

King Georges Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

King Georges Medical University

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Reetu Verma

Principal investigator

9473641975

reetuverma1998@gmail.com