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CTRI Number  CTRI/2019/11/022086 [Registered on: 20/11/2019] Trial Registered Prospectively
Last Modified On: 19/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of peripheral nerve block as post operative analgesia in modified radical mastectomy 
Scientific Title of Study   Efficacy of peripheral nerve stimulator guided pectoral nerve block I and serratus anterior plane block for post-operative analgesia in modified radical mastectomy - A randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ananda Jyothi V M 
Designation  PG Student 
Affiliation  SSG Hospital, Vadodara 
Address  Department of Anaesthesiology SSG Hospital

Vadodara
GUJARAT
390001
India 
Phone  9840217023  
Fax    
Email  annejyo@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Devyani Desai 
Designation  Associate Professor 
Affiliation  S.S.G Hospital 
Address  Department of Anaesthesiology S.S.G.Hospital

Vadodara
GUJARAT
390001
India 
Phone  9909983168  
Fax    
Email  devyani.dr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Devyani Desai 
Designation  Associate Professor 
Affiliation  S.S.G Hospital 
Address  Department of Anaesthesiology S.S.G.Hospital

Vadodara
GUJARAT
390001
India 
Phone  9909983168  
Fax    
Email  devyani.dr@gmail.com  
 
Source of Monetary or Material Support  
SSG Hospital, Vadodara 
 
Primary Sponsor  
Name  SSG Hospital Vadodara 
Address  SSG Hospital, Sayajigunj, Vadodara. 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr VM Ananda Jyothi  SSG Hospital  Department of Anaesthesiology, New Surgical block
Vadodara
GUJARAT 
9840217023

annejyo@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research (IECHR) - Post Graduate Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General Anaesthesia  Inj Paracetamol 1g 
Intervention  PNS guided Pectoral nerve block-I and serratus anterior plane block  Injection Bupivacaine 0.5% 15 cc Injection sterile water 15cc  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1)All patients having Unilateral Breast Carcinoma 2)ASA – II/III
3)Scheduled for Modified Radical Mastectomy  
 
ExclusionCriteria 
Details  1)Patient’s refusal
2)Patients with allergy to study medication such as Bupivacaine and Tramadol.
3)Locally advanced breast malignancies with skin ulceration or infiltration of chest wall 4)Long-term analgesic therapy
5)Bleeding dyscrasias
6)Patient on anticoagulants
7)History of neurological or neuromuscular disorders
8)Deranged liver function tests
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale (VAS) Score (post operatively).  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1) Time to give 1st rescue analgesia
2) Total dose requirement of rescue analgesics in 1st 24 hours.
3) Associated perioperative complications  
24 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/11/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
The study will be a type of prospective randomized controlled study undertaken in adults patients undergoing MRM admitted in SSG Hospital with a sample size of 60 patients, 

Patient to be kept nil by mouth (NBM) for minimum 6-8 hours and an intravenous line will be secured. After thorough pre-anaesthetic evaluation all the patients falling in the inclusion criteria will be selected and informed written consent will be taken from the patient 

After taking patient inside the operation theatre, multipara monitor will be attached and baseline vital parameter like pulse rate, bood pressure, SpO2, ECG will be noted. As premedication, Inj. Glycoprrolate 5mcg/kg iv and Inj. Tramadol 2mg/kg iv 5 minutes prior to induction. 
 
Induction will be the same in both groups A and B, starting preoxygenation with 100% O2 for 3min will be done by using close circuit of Fabius anaesthesia machine.Inj. Propofol 2 mg/kg IV will be given till loss of eye lash reflex. Inj. Suxamethonium Chloride 2 mg/kg IV given after check ventilation.Intubation will be done in sniffing position by direct laryngoscopy with no 3 mac blade with appropriate size endotracheal tube after disappearance of fasciculation and confirmed by Capnometry. Patient will be then ventilated with Oâ‚‚ & Nâ‚‚O (50:50%) gases along with inhalational agent Sevoflurane turned on. Inj.Vecuronium bromide 0.1 mg/kg will be given as loading dose. (Muscle relaxants will be given intravenously after performing blocks in case of group B patients). 
Block will be performed in group B patients using peripheral nerve stimulator and drug will be prepared as Injection Bupivacaine 0.5% 15 cc; Injection sterile water 15cc; Total drug 30cc of 0.25% Bupivacaine. 

PEC I BLOCK 
• The PEC-I block will be performed with the guidance of PNS with the patient lying in supine position with ipsilateral arm slightly abducted. The landmark will be the point of intersection of angle of Louis (2nd Rib) and the anterior axillary line where the needle will be inserted. The block will be done with a 50 mm insulated nerve stimulator needle with syringe filled with local anaesthetic (LA) attached to the extension tubing and the needle will be inserted perpendicular to the skin, at the landmark described above. The PNS will be initially set at 2.5 - 3 mA current, 0.1ms duration and frequency of 1Hz. The needle then slowly advanced till the pectoralis muscle contractions noted. The needle will be kept at this depth and current will be gradually reduced to 0.6mA. Persistence of contraction of pectoralis muscle at this level confirms the needle placement at the target site thereby blocking lateral pectoral nerve and medial pectoral nerve. Injection Bupivacaine 0.25% of 10cc will be then slowly injected in increments with frequent negative aspirations.

 â€¢ SAP BLOCK 
The SAP block will be performed with the guidance of PNS with the patient lying in                      supine position and ipsilateral arm abducted. The landmark will be the point of intersection of 5th Rib and the mid axillary line where the needle is inserted. The block will be done with a 50 mm insulated nerve stimulator needle with syringe filled with local anaesthetic (LA) attached to the extension tubing and the needle will be inserted perpendicular to the skin, at the landmark described above. The PNS will be initially set at 2.5 - 3 mA current, 0.1ms duration, and frequency of 1Hz. The needle will be slowly advanced till the serratus anterior muscle contractions noted. The needle will be kept at this depth and current will be gradually reduced to 0.6 mA. Persistence of contraction of serratus anterior muscle at this level confirms the needle placement at the target site thereby blocking lateral and posterior cutaneous branches of intercostal nerves and long thoracic nerve . Injection Bupivacaine 0.25% of 20cc will be then slowly injected in increments with frequent negative aspirations. 
Cylinders and circuits will be checked, airway equipment and drugs will be kept ready before induction. 
All the blocks will be given by me after a learning curve of 10 such cases. 

Maintainence:  
Patient will be then maintained with Oâ‚‚+Nâ‚‚O (50:50) with sevoflurane and vecuronium bromide 0.02 mg/kg. Intraoperative rise in heart rate and systolic blood pressure ≥ 20% from pre induction value will be managed by giving intravenous Inj. fentanyl 0.25microgram/kg. Fluid requirement and blood loss will be calculated and replaced accordingly. Towards the end of surgery, all patients (in group A and B) will be given inj. Paracetamol 1g/100ml intravenously. 

Reversal
At the end of surgery N2O and anaesthetic agent will be stopped before 10 mins and patient will be ventilated with 100% oxygen. Reversal of residual neuromuscular block will be done, once patient starts spontaneous breathing, with Inj. Neostigmine - 50 mcg/kg iv and Inj. Glycopyrrolate - 10 mcg/kg iv. 
During this period patient will be ventilated with 100% oxygen with fresh gas flow of 4- 6 litres/min. Patient will be extubated when regular spontaneous breathing pattern become established and able to open the eyes on command. Patient will then be shifted to recovery room after monitoring for 15minutes inside operation theatre. 
 
 
1. POSTOPERATIVE MONITORING: 
(i) VAS Score:     Score recorded by making handwritten mark on a 10cm line that represents a continuum between “no pain” and “worst pain”. Postoperatively patient will be enquired regarding intensity of pain at rest, with mild pressure over surgical site and with movements over shoulder joint. VAS score will be assessed every 1hour for first 6 hours, every 2 hours for next 6 hours and at 18 and 24 hours.

 (ii) TIME OF 1ST RESCUE ANALGESIA GIVEN: Rescue analgesia will be given in the form of inj. Tramadol 2 mg/kg   intravenously when VAS score will be ≥ 4 and time at which 1st rescue analgesic required will be noted. Time from when the blocks given till the supplementation of 1st rescue analgesic will be considered as duration of postoperative analgesia. 
 
(iii) TOTAL REQUIREMENT OF RESCUE ANALGESIA IN 1ST 24 HOURS:         
Total number of doses of rescue analgesics given in 1st 24 hours will be noted.  

(iv) PERI OPERATIVE COMPLICATIONS  
• Pneumothorax – if suspected immediate  CXR will be done and ICD insertion if necessary. 
• Local anaesthetics toxicity – will be treated symptomatically. 
• Postoperative nausea and vomiting – will be treated by Inj. Ondansetron  0.15 mg/kg iv. 
 
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