To Check the Usefulness of Local Anesthetic injection into the Erector Spinae muscle (ERECTOR SPINAE BLOCK) in Patients operated for Breast Cancer.

Not yet recruiting

Conditions: Malignant neoplasm of breast,

Registration Number: CTRI/2019/06/019701

Lead Sponsor: Dr J V Divatia

Brief Summary: **BACK GROUND AND INTRODUCTION:**

Breast cancer has been ranked number one cancer in Indian females. Surgery being the mainstay of treatment, General anaesthesia is conventionally used for most breast surgeries.Opioids and NSAIDâ€™S are commonly used for analgesia. In female population undergoing breastcancer surgery it has been estimated that the incidence of chronic postoperative pain rangesfrom 25% to 50%. Among main factors responsible for it being the higher acute postoperativepain, its intensity and analgesic consumption in the acute postoperative period. One important side effect of opioids usage is PONV. Postoperative nausea and vomiting (PONV)continue to be one of the most common and disturbing complications patients experience aftersurgery, with an incidence as high as 80%. PONV has significant morbidity (dehydration,wound dehiscence, pain, immobility), delayed discharge, increased hospital costs, and poorpatient satisfaction.

Regional anaesthesia is widely preferred these days as they decrease the opioid requirements,thereby reducing their side effects as well. It also provides a good mode of analgesia.Regional anaesthesia commenced before surgical incision reduces incidence of chronicpostsurgical pain and Post Mastectomy Pain Syndrome prevalence.THE ERECTOR SPINAE BLOCK (ESB) is an interfascial plane block. It produces extensivemultidermatomal sensory blockade with its likely site of action at the dorsal and ventral rami of the thoracic spinal nerves. Local anesthetic deposited deep to erector spinae muscle whichextends along the length of thoracolumbar spine, this plane permits extensive cranio-caudalspread and coverage of multiple dermatomes. Itâ€™s a promising technique for thoracic analgesiain chronic neuropathic as well as acute post-surgical and post traumatic pain. Even though many Regional techniques for breast surgeries has shown many benefits overGeneral anesthesia alone, the significant advantage of the ESP Block being its simplicity andsafety, not time consuming and considered a better alternative to other techniques in breastcancer surgeries. The sonoanatomy is easily recognizable, and there are no structures at riskof needle injury in the immediate vicinity. Recently published Case reports of Erector spinae block being used as a regional technique inbreast surgeries have shown better post op outcome and analgesia, opioid sparing effect,possible immunomodulatory effect and better patient satisfaction. However, except for thesecase reports on ESB for Breast surgeries, no RCT has been conducted so far, to prove theefficacy of ESB in breast surgeries over General Anesthesia alone and if it can be routinelypreferred as a regional technique in breast surgeries.

AIMS AND OBJECTIVES:

The OBJECTIVE of the study is to find the efficacy of ESB in controlling pain in Breast surgerypatients

PRIMARY AIM is to compare the following in patients undergoing Modified Radical Mastectomywith Axillary dissection/clearance under General Anaesthesia alone and in patients receivingErector spinae block along with General Anaesthesia,

1.Time to first analgesic requirement (Time between admission in PACU to request for firstrescue pain medication)

SECONDARY AIM is to compare the following between two groups:

1. Total intraoperative opioid consumption

2. Post-operative pain scores

3. To assess Incidence of PONV

4. Patient satisfaction scores at discharge

STUDY DESIGN:

Prospective, interventional, Double blinded, comparative Randomised controlled study

MATERIALS AND METHODS:

After approval from Institutional Review Board, Patients belonging to the inclusion criteria willbe recruited in the study after obtaining a written consent. Since the study will presented as athesis for MD (Anaesthesia) in May 2020 and will not be able to recruit all the subjects beforeDecember 2019, the data of patients recruited till 30th November 2019 will be analysed forthesis purpose. It will be carried out at Tata Memorial Centre, Mumbai.

Sample size:

In a Previous study done by somia et al, on Modified PECS block in breastsurgeries,Time to rescue(TTR) analgesic increased by 2.30hrs, we expect that the Erector spinaeblock would prolong TTR by 4Hrs. In order to achieve this, we have taken SD=2, Significancelevel (alpha) of 0.05, power 80%, the actual sample size calculated is 25 patients in each arm, butwe have taken 35 patients in each control and study arm respectively, to account for errors,protocol violations, etc, a total of 70 patients, 35 in each group will be randomised in the trial

Randomisation would be by computer generated random numbers, and patients will bedivided into two study groups

Blinding: This is a Double blinded study. The patients are blinded as they are given the blockunder anaesthesia. The block will be given in induction room where OT anaesthetists will not bepresent. The Acute Pain service team who evaluates patient in PACU and ward are also blindedand wouldnâ€™t know if the patient has received the block or not.

STUDY PROCEDURE:

GROUP A: These patients will undergo Breast surgery under General Anaesthesia. In inductionroom, Under All standard anaesthesia monitoring, Induction of anaesthesia will be done byPropofol 1-2mg/kg, fentanyl 2mcg/kg and Muscle relaxant Atracurium 0.4-0.5mg/kg orVecuronium 0.1mg/kg. An appropriate size Supraglottic device/ETT will be placed.

Whereas in GROUP B: Patients will be placed in lateral decubitus position after induction, USGguided, probe in parasagittal plane, up to 3cm lateral to midline of at level of 5th thoracicvertebra, using in-plane technique, Erector spinae muscle is identified, and drug is depositedbelow the muscle using a 20G,10cm Stimuplex needle and 20ml of 0.25% Bupivacaine will beinjected into the plane.The block will be performed by PI, CO PI and CI, under the supervision of PI/CO PI, provided thePI & CI had given at least 10 blocks under guidance of CO PI who has good expertise in givingthis block.Patients are shifted to Operation room, and Maintenance will be withO2+Air+Sevoflurane+IPPV. Intra op Fentanyl bolus of 0.5mcg/kg iv will be given with 20%increase in heart rate/Blood pressure from baselineIntra-op Paracetamol 15mg/kg iv, Inj Diclofenac 1mg/kg and Inj Ondansetron 4mg,Dexamethasone 4mg will be given for Pain and PONV prevention respectively. Neuromuscularblockade will be reversed with Neostigmine+ Glycopyrrolate, SLMA/ETT removed and patientwill be shifted to PACU

In PACU,

At the time of performance of block, itâ€™s not possible to check the dermatomal spread, aspatient is under Anesthesia. But in post op period, in PACU, dermatomal spread can be checkedusing Ice test once patient is wide awakeTime to first rescue analgesic (time point measured from end of surgery to request of analgesicOR pain score >/= 4) will be noted in both group of patients. All the patients will be followed upin ward after discharge from PACU, we will monitor all the patients in PACU or ward till theyreceive the first rescue.Inj Fentanyl bolus iv will be given as first rescue analgesic if Pain score >/= 4 or patient requestsfor pain medication. (If Within 8hrs of intra-op paracetamol)Inj Paracetamol 15mg/kg will be given (If more than 8hrs from intraop paracetamol)Also, Total opioid and analgesic consumption, pain scores, and Incidence of PONV in first 24hours/until discharge will be recorded in both group of patientsPain scores will be assessed by the Acute Pain Services, who are blinded to the study, using aNumerical rating scale(NRS) on a scale of 0-10, (0 being no pain and 10 being worst pain) andrecorded on arrival to PACU, at 1 hr, 2hrs, 6hrs, 12hrs and by the end of 24hrs/ Or untildischargeTo assess Incidence of PONV â€“ Nausea as yes/no and Vomiting, assessed both by binaryvariable(yes/no) and as continuous variable to measure the number of separate emetic events.Patient satisfaction score will be assessed in PACU by a scoring system of 1-4. 1- Not satisfied,2- Fairly satisfied, 3- Satisfied, 4- Extremely satisfied.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 70

Inclusion Criteria

Female patients age of 18-65years, belonging to ASA I and II categories, undergoing Unilateral Modified Radical Mastectomy + Axillary Clearance/dissection.

Exclusion Criteria

Patients belonging to ASA III OR IV category Patients aged <18 or >65years Asthmatics ( As NSAIDâ€™S has to be avoided in them ) Patient refusal B/L Breast Surgeries/ MRM+ Port insertion/BCT +BSO/Reconstructive surgeries Infection at injection site Spinal deformities Coagulation disorders Allergy to local anaesthetics History of opioid usage for Chronic pain Cognitive, psychiatric disorders.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first analgesic requirement (Time between admission in PACU to request for first rescue pain medication)	24 hours post surgery or at discharge

Secondary Outcome Measures

Name	Time	Method
1. Total intraoperative opioid consumption	2. Post-operative pain scores

Trial Locations

Locations (1): Tata Memorial Centre
🇮🇳
Mumbai, MAHARASHTRA, India
Tata Memorial Centre
🇮🇳Mumbai, MAHARASHTRA, India
Dr J V Divatia
Principal investigator
9869077435
jdivatia@yahoo.com