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CTRI Number  CTRI/2021/03/032366 [Registered on: 26/03/2021] Trial Registered Prospectively
Last Modified On: 19/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Continuous Erector spinae plane block for pain relief in breast cancer surgery patients 
Scientific Title of Study   Ultrasound guided Continuous Erector spinae plane block for peri operative opioid sparing analgesia in Breast cancer surgery: A Randomized controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
12000004  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalini Bajpai 
Designation  Associate professor 
Affiliation  Homi Bhabha cancer hospital and research centre 
Address  Dept. Of anaesthesia, critical care and pain, Homi Bhabha cancer hospital and research centre, Aganampudi, Visakhapatnam (A.P) 530053
Homi Bhabha cancer hospital and research centre, Aganampudi, Visakhapatnam (A.P) 530053
Visakhapatnam
ANDHRA PRADESH
530053
India 
Phone  9666429374  
Fax    
Email  shln.bajpai@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shalini Bajpai 
Designation  Associate professor 
Affiliation  Homi Bhabha cancer hospital and research centre 
Address  Dept. Of anaesthesia, critical care and pain, Homi Bhabha cancer hospital and research centre, Aganampudi, Visakhapatnam (A.P) 530053
Homi Bhabha cancer hospital and research centre, Aganampudi, Visakhapatnam (A.P) 530053
Visakhapatnam
ANDHRA PRADESH
530053
India 
Phone  9666429374  
Fax    
Email  shln.bajpai@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shalini Bajpai 
Designation  Associate professor 
Affiliation  Homi Bhabha cancer hospital and research centre 
Address  Dept. Of anaesthesia, critical care and pain, Homi Bhabha cancer hospital and research centre, Aganampudi, Visakhapatnam (A.P) 530053
Homi Bhabha cancer hospital and research centre, Aganampudi, Visakhapatnam (A.P) 530053
Visakhapatnam
ANDHRA PRADESH
530053
India 
Phone  9666429374  
Fax    
Email  shln.bajpai@gmail.com  
 
Source of Monetary or Material Support  
Dept. of Anaesthesia, Critical care and pain,Homi Bhabha cancer hospital and research centre, Aganampudi, Visakhapatnam(A.P)530053  
 
Primary Sponsor  
Name  Dr Shalini Bajpai 
Address  Dept. of Anaesthesia, Critical care and pain, Homi Bhabha cancer hospital and research centre, Aganampudi, Visakhapatnam (A.P) 530053 
Type of Sponsor  Other [self funded] 
 
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 Shalini Bajpai  Homi Bhabha cancer hospital and research centre  Department of Anaesthesia, critical care and pain, Main OT Block, 3 rd floor, VPT hospital campus, Homi Bhabha cancer hospital and research centre, Akkayapalem Visakhapatnam (A.P) 530016
Visakhapatnam
ANDHRA PRADESH 
9666429374

shln.bajpai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee,Homi Bhabha cancer hospital and research centre, Visakhapatnam   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Continuous Erector spinae plane block  Patient in sitting position, USG guided ESP Block will be given at T3 level by 18 G Tuohy needle and 25 ml of 0.25% Bupivacaine will be injected in the plane followed by insertion of ESP catheter through which continuous infusion of 0.1% Bupivacaine will be given at 5 ml/hr for 24 hours in post operative period 
Comparator Agent  Standard General Anaesthesia  These patients will undergo breast surgery under General Anaesthesia. Induction of anaesthesia will be done by Inj. propofol2-2.5 mg/kg, Inj Fentanyl 2 mcg/kg, and muscle relaxant Inj. vecuronium 0.1 mg/kg. An appropriate size LMA/ Endotracheal tube will be placed and anaesthesia will be maintained as per standard institutional protocol 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  American Society of Anesthesiologists (ASA) physical status I–II
Elective surgery for breast cancer.
Unilateral surgical procedures [ MRM (Modified radical mastectomy) , BCS ( Breast conservation surgery)]
 
 
ExclusionCriteria 
Details  BMI (body mass index ) > 35 kg/m2
Infection of the skin at the site of the needle puncture
Known allergies to Local Anaesthetics
Mastectomy with simultaneous reconstructive surgery using a muscle flap or implant
Coagulopathies
Chronic use of opioid drugs.
Psychosis
Refusal to give consent
Pregnant and Lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment
Modification(s)  
Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Total postoperative opioid (Tramadol)consumption   In 24 hours post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Pain score (Numeric pain rating scale 0 to 10)   0,1,2,6,12,24 hours post surgery 
Intra operative opioid (fentanyl) consumption   from induction of anaesthesia to reversal of neuromuscular blockade 
Incidence of PONV( post operative nausea and vomiting  24 hours post surgery 
Patient satisfaction score   At discharge 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2021 
Date of Study Completion (India) 02/11/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Background:  In India, one of the most common cancers among women is carcinoma breast (25%–32%).   Multimodal analgesia is standard of care for pain relief in breast cancer surgeries . Conventionally, General Anaesthesia is used in breast surgeries in which opioids are commonly used for pain relief. When given in the immediate post operative period after general anaesthesia, side effects like nausea, vomiting, pruritus, constipation, drowsiness, respiratory depression may occur because of opioids use in first 24 hrs post surgery. Regional anaesthetic techniques used for breast surgery have shown reduced opioid requirements along with providing good pain relief, reduced postoperative nausea/vomiting (PONV), reduced incidence of chronic pain, and early rehabilitation. The erector spinae plane (ESP) block is a novel regional anesthesia technique for thoracic surgery analgesia and neuropathic pain . It an interfascial block which provides multidermatomal analgesia due to its extensive craniocaudal spread by blocking the dorsal and ventral rami of spinal nerves. Its advantage over other RA techniques includes easy technique, performed away from pleura and neuraxis avoiding any complications, less time consuming, easy catheter insertion, and broad coverage  .Though recent studies of ESP have shown significant reduction in opioid consumption, good post operative analgesia but the results about duration of ESP block has been equivocal. Considering the limited duration of single shot ESP block, opioids are again required in late post operative period for pain relief. To overcome the limited duration of ESP block, a Continuous ESP block (continuous infusion of local anaesthetic in ESP block)   can be given to provide sustained pain relief. We propose that a Continuous Erector spinae plane block will provide effective analgesia in early as well as  late postoperative period and maintaining the catheter for 24 hrs post surgery will be  advantageous in providing sustained pain relief and reduce opioid requirements to minimum. The purpose of this study is to evaluate the analgesic efficacy and opioid sparing effect of US-guided continuous ESP block in patients undergoing elective breast cancer surgery.

AIMS AND OBJECTIVES

Primary objective

 To compare total postoperative opioid (Tramadol) consumption in 24 hours post surgery.

 Secondary objectives: To compare the following between two groups

·         Pain scores (NRS 0-10) in 24 hrs post surgery.

·         Incidence of Post operative  nausea and vomiting in 24 hrs post surgery

·         Intra operative  opioid ( fentanyl )consumption

·         Patient satisfaction score at discharge.

MATERIALS AND METHODS

Study design: Single centre, prospective, randomized controlled study to be undertaken after ethical committee approval at  Homi Bhabha cancer Hospital and Research Centre, Visakhapatnam (A.P)

Study procedure: On day of surgery, all patients fulfilling  inclusion criteria will be will be randomly assigned to either Group B (Block group) or Group C (Control group) as per computer generated random allocation table. Patients in group B will receive USG guided Continuous ESP block while patients in group C will not receive any intervention. Both group patients will receive general anaesthesia similarly as per standard protocol.

 Continuous ESP block technique: All patients in group B will be given Continuous ESP block in the preoperative block area, using 6-13 MHz linear array ultrasound transducer placed at T3 level in craniocaudal direction , 3cm away from midline to identify the  T3 transverse process  and overlying Erector spinae muscle . A 18G Tuohy needle will be introduced in a cranio caudal direction, using in plane technique and navigated to touch the transverse process underneath the erector spinae muscle and 25 ml of 0.25% Bupivacaine will be injected in interfacial plane deep to erector spinae muscle . It will be followed by threading a 18 G multiport epidural catheter through the needle caudally,   atleast 5cm beyond the needle tip, deep to Erector spinae muscle plane . All group B patients will be then taken to operation theatre and General Anaesthesia will be given as per standard protocol described below. Continuous ESP infusion of 0.1% Bupivacaine at 5 ml/hr will be started through the catheter towards the end of surgery,  and will be continued in post operative period for 24 hours using elastomeric infuser.

General Anaesthesia procedure:  General anaesthesia will be given similarly to all patients of group B (after ESP block) and group C as per standard protocol. After premedication with Inj Midazolam 0.03 mg/kg , all patients will be induced with Inj. Propofol 2-2.5 mg/kg, Inj. Fentanyl 2mcg/kg and muscle relaxant Inj. Vecuronium 0.1mg/kg I.V. An appropriate size endotracheal tube (ETT) / supraglottic device (SGA) will be placed. Maintainence will be with sevoflurane 2 %, 66% N2O in oxygen and intermittent positive pressure ventilation . Bolus of Inj. Fentanyl 0.5mcg/kg I.V will be administered to treat rise in heart rate / blood pressure (2 consecutive readings of 20% above baseline). Total intra operative fentanyl consumption will be recorded.  Towards the end of surgery, Inj. Paracetamol 1gm and Inj Ondansetron 8mg I.V will be given for pain relief and PONV prevention respectively. Neuromuscular blockade will be reversed Inj. Neostigmine 0.05mg/kg and Inj. Glycopyrrolate 0.01mg/kg I.V, ETT/SGA removed and patient will be shifted to post anaesthesia care unit (PACU).

All patients will be monitored in post operative period and postoperative analgesia will be provided with Inj Paracetamol 1gm every 8 hr IV. Pain score will be evaluated by means of a Numerical rating scale (NRS) and recorded at the time of arrival in PACU at 0 hr and then at 1,2, 6, 12, and 24 h after surgery.   Rescue analgesia will be given with intravenous Inj.Tramadol 1mg/kg if NRS ≥4 or patient demands analgesic medication (within 8 hr of giving due dose of Inj Paracetamol 1gm IV). Total Tramadol consumption in 24 hours post surgery will be recorded.  Incidence of nausea and vomiting in post operative period will be recorded and managed by Inj Ondansetron 8 mg IV. Patient satisfaction score will be recorded at discharge by 5 point Likert scale (5-Very satisfied, 4- Relatively satisfied, 3- Neutral, 2-Relatively dissatisfied, 1- Very dissatisfied)

Statistics:

Sample size estimation:  To detect a 50% difference in postoperative opioid requirements at 24 hr using ESP compared to the control group (GA) for 90% power and an alpha error of 0.01, sample size calculated as 21 subjects for each group.  We intend to include 25 patients in each group for securing patient dropouts, thus making sample size 50. [Mean+SD of control group for sample size calculation is taken from referral study by Gurkan et al ]

Statistical analysis: Descriptive statistics will be performed with SPSS software, version 26.0. Qualitative variables will be expressed as numbers and percentage and quantitative variables as means, standard deviation, medians, IQR as appropriate

 

 
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