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
|
|
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
|
|
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. |