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 |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
12000004 |
Protocol Number |
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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
|
|
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 |
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Regulatory Clearance Status from DCGI
|
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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
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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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