FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/03/031811 [Registered on: 08/03/2021] Trial Registered Prospectively
Last Modified On: 05/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two different ultrasound guided blocks for breast surgeries  
Scientific Title of Study   Comparison Of Ultrasound Guided Erector Spinae Plane Block With Serratus Anterior Plane Block For Post Operative Analgesia following breast surgeries:A double blinded randomized control study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramesh Koppal 
Designation  Professor 
Affiliation  S N Meddical college Bagalkot 
Address  Dept of Anaesthesia, S N Medical college, Navanagar, Bagalkot
Dept of Anaesthesia, S N Medical college, Navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India 
Phone  9845504515  
Fax    
Email  rameshkoppaldr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramesh Koppal 
Designation  Professor 
Affiliation  S N Meddical college Bagalkot 
Address  Dept of Anaesthesia, S N Medical college Navanagar, Bagalkot
Dept of Anaesthesia, S N Medical college Navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India 
Phone  9845504515  
Fax    
Email  rameshkoppaldr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Subhash Reddy 
Designation  PG in Anaesthesia 
Affiliation  S N Meddical college Bagalkot 
Address  Dept of Anaesthesia, S N Medical college, Navanagar Bagalkot
Dept of Anaesthesia, S N Medical college, Navanagar Bagalkot
Bagalkot
KARNATAKA
587102
India 
Phone  9052032550  
Fax    
Email  subhashreddy93.sr@gmail.com  
 
Source of Monetary or Material Support  
S Nijalingappa Medical College and HSK Hospital Bagalkot 
 
Primary Sponsor  
Name  S Nijalingappa medical college and HSK hospital hospital 
Address  1st floor, Major OT complex S Nijalingappa medical college and HSK hospital hospital Bagalkot  
Type of Sponsor  Private 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 Ramesh Koppal  Major OT complex,   1st floor, S N Medical college and HSK hospital
Bagalkot
KARNATAKA 
9845504515

rameshkoppaldr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SNMC-INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, (2) ICD-10 Condition: M728||Other fibroblastic disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector spinae plane(ESP) block  A 22-gauge, 100mm echogenic stimuplex needle is inserted using an in-plane superior to inferior approach to place the tip into fascial plane on the deep(anterior) aspect of erector spinae muscle. The location of the needle tip is confirmed by visible fluid spread between the transverse process and erector spinae muscle group 
Comparator Agent  Serratus Anterior Plane (SAP) block  After identifying the second rib, the probe is moved caudally and laterally (obliquely), towards the mid-axillary line to identify the 3rd, 4th and 5th ribs. The final probe position has its cephalad end resting over the anterior axillary line and the caudad end over the posterior axillary line. The fascial plane between the serratus anterior muscle and latissimus dorsi muscle is identified between the 4th and 5th rib in the mid-axillary region. Under ultrasound guidance, a 22-gauge, 100 mm echogenic stimuplex needle is advanced in-plane to enter this fascial plane in the superoanterior to posteroinferior direction6 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.ASA I-II
2.Patients aged between 18-80years
3.Patients undergoing elective breast surgery 
 
ExclusionCriteria 
Details  1.Refusal at enrollment
2.Patients with coagulation system disorders
3.Patients with raised intracranial tension
4.Patients with hepatic/renal failure
5.Chronic use of opioids or corticosteroids
6.Patients allergic to local anesthetics 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Erector spinae plane block may be superior than serratus anterior plane block in providing postop analgesia  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Total amount of opioid consumption  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)   11/03/2021 
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="6"
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)?  

Response - NO
Brief Summary  

Ultrasound guided inter fascial plane blocks such as pectoral nerve(PECS) block, serratus anterior plane block(SAP) and erector spinae plane block(ESP) which is a recent block newly described for various surgeries for postoperative analgesia have also been reported as alternatives, with advantages of simplicity, ease of performance and fewer complications.There are no sufficient randomized controlled trails that assess the effectiveness and safety of erector spinae plane block and serratus anterior plane block.

Primary objective: To compare the duration of postoperative analgesia following ultrasound guided erector spinae plane block and serratus anterior plane block in breast surgeries using visual analogue  scale (VAS)  Secondary objectives: 1. Time taken to first opioid analgesia in post anaesthetic care    2. Total postoperative opioid consumption in 24hrs.

The patients participating in this study will be randomly grouped into group A and group B. Random allocation into these groups will be done by computer generated random numbers. For Group A patients  erector spinae  (ESP) block will be given and for Group B patients Serratus Anterior plane (SAP) block will be given for post-operative analgesia. Investigators involved in data collection will also be masked to the patients group allocation and did not have any access to the randomization until data analysis was complete. Therefore, this study has a double blind design. After shifting the patients to OT, intravenous cannula of appropriate size will be secured and IV fluid ringer lactate will be started. Pulse rate ,noninvasive blood pressure, saturation of oxygen, ECG will be monitored. All patients will receive same anaesthesia and analgesia protocol. Post-operative pain assessment will be done using Visual Analogue Scale (VAS) during 1st, 2nd, 4th, 6th, 8th, 10th, 12th & 24 hours

The pain VAS  is considered as a unidimensional measure of pain intensity in adults. The intensity of postoperative  pain is recorded for all patients using VAS score (0 is no pain and 10 is worst possible pain). Using a ruler, the score is determined by measuring the distance on the 10cm line between the no pain anchor and the patients mark, providing a range of scores from 0 to 10. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post operative patients, the following cutoff  points on VAS have been recommended.

0 No pain

1 to 3 cm  Mild pain

4 to 6 cm Moderate pain

7 to 10 cm  Severe pain

Average time duration to administer first postoperative analgesia ( rescue analgesia) is noted. Rescue analgesia (Tramadol iv50mg) is considered when VAS more than 4. 

Vitals will be monitored and maintained throughout the surgery.

Both erector spinae plane block & serratus anterior plane blocks performed under ultrasound guidance significantly reduce the VAS pain score and analgesic requirement for up to 24 hours without any major complications. Further the study is going to establish that erector spinae plane block might be more effective than serratus anterior plane block in post-operative analgesia and it can further improve quality of multimodal analgesia during post-operative period.


 
Close