CTRI Number |
CTRI/2022/07/044423 [Registered on: 28/07/2022] Trial Registered Prospectively |
Last Modified On: |
24/07/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Anaesthesia to reduce pain after breast surgery |
Scientific Title of Study
|
Comparison of efficacy of ultrasound guided thoracic paravertebral block (TPVB) with combined pectoral nerve block (PEC) and pecto-intercostal fascial block (PICF) for perioperative analgesia in modified radical mastectomy: a randomised control trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Adarsh M Sheshagiri |
Designation |
PG Resident |
Affiliation |
AIIMS Patna |
Address |
Department of Anaesthesiology
Room No 13, OPD Complex
AIIMS Patna, Phulwarisharif
Patna
Bihar
Patna BIHAR 801507 India |
Phone |
7026748639 |
Fax |
|
Email |
msadarsh256@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Ajeet Kumar |
Designation |
Additional Professor |
Affiliation |
AIIMS Patna |
Address |
Department of Anaesthesiology
Room No 13, OPD Complex
AIIMS Patna, Phulwarisharif
Patna
Bihar
Patna BIHAR 801507 India |
Phone |
9312501413 |
Fax |
|
Email |
ajeetanaes@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Ajeet Kumar |
Designation |
Additional Professor |
Affiliation |
AIIMS Patna |
Address |
Department of Anaesthesiology
Room No 13, OPD Complex
AIIMS Patna, Phulwarisharif
Patna
Bihar
Rohtas BIHAR 801507 India |
Phone |
9312501413 |
Fax |
|
Email |
ajeetanaes@gmail.com |
|
Source of Monetary or Material Support
|
Department of anaesthesiology, All india institute of medical sciences, Phulwarisharif, Patna |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences |
Address |
Department of Anaesthesiology
B Block OT Complex
AIIMS Patna, Phulwarisharif
Patna
Bihar
|
Type of Sponsor |
Government 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 |
Adarsh M Sheshagiri |
All India Institute of Medical Sciences, Patna |
Department of Anaesthesiology
B Block OT complex
AIIMS Patna, Phulwarisharif
Patna
Bihar
Patna BIHAR |
7026748639
msadarsh256@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC AIIMS PATNA |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Pectoral nerve block(PEC) WITH Pecto intercoastal fascial block(PICF) |
Group 2 patients will receive PEC BLOCK and PICF BLOCK. In PEC Block 20ml of 0.2% ropivacaine will be deposited between pectoralis minor and serratus anterior, 10ml of 0.2% ropivacaine in between pectoralis major and pectoral minor. PICF block 15ml of 0.2% ropivacaine will be deposited between the pectoralis major and external intercostal muscles. data will be collected 24 hours post operatively. |
Comparator Agent |
Thoracic Paravertebral Block |
Group 1 will receive 20ml of 0.2% ropivacaine in the paravertebral space of the surgical side after induction of general anaesthesia, data will be collected till first 24 hours postoperatively. |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Female |
Details |
1. Adult aged between 30-70 Yrs.
2. Posted for unilateral MRM
3. ASA I-II
|
|
ExclusionCriteria |
Details |
1. Patients refusal
2. Sensitivity to LA
3. Bleeding disorders
4. patients on anticoagulants
5. BMI of more than 35 kg/m2
6. Spine/chest wall deformity
7. Pregnancy
8. Inability to understand NRS and PCA device use
9. Current chronic opioids use
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Time for first rescue analgesia noted in minutes/hours
|
Not applicable
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Postoperative morphine consumption in the first 24 hours |
End of post operative 24 hour |
Post-operative NRS on rest and movement |
0,1,2,4,6,12,24 hour post surgery |
Total opioid consumption |
first 24 hour |
Complication
Patient satisfactory score |
end of 24th hour |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/08/2022 |
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
|
Breast cancer is the most frequent cancer among Indian women accounting for 25 to 32 per cent. Surgical resection of the primary tumour with axillary dissection is one of the most important therapeutic procedures for breast cancer. Most breast surgeries are done in general anaesthesia, with or without regional blocks. Forty per cent of women experience moderate to severe pain following breast cancer surgery in the first few days. Various regional anaesthesia techniques including thoracic paravertebral block, Erector spinae plane block, PEC block etc. have been used for perioperative analgesia in breast cancer surgery to decrease opioid consumption and its side effect. Poor management of acute postoperative pain may lead to persistent postoperative pain with an incidence of 25 to 60% of patients. These blocks are found to be effective for postoperative analgesia and also decrease the incidence of post-mastectomy pain syndrome. The paravertebral block is considered the gold standard for breast surgery but this block is associated with many complications. Recently interfacial blocks (pectoral nerve blocks) have been used for post-op analgesia in breast surgery. This study aims to compare the efficacy of ultrasound-guided combined pectoral nerve block and pecto intercostal fascial block with thoracic paravertebral block for perioperative analgesia for MRM, and to find which requires less opioid consumption, better NRS, fewer complications, a better patient satisfactory score. |