| CTRI Number |
CTRI/2018/03/012712 [Registered on: 21/03/2018] Trial Registered Prospectively |
| Last Modified On: |
21/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of nerve block for after surgery pain relief in breast surgery. |
|
Scientific Title of Study
|
comparison of erector spinae block for postoperative analgesia in breast surgery- 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 |
Gunjan Kumar |
| Designation |
Senior Resident |
| Affiliation |
Institute of medical sciences, patna |
| Address |
Department of Anaesthesia, IGIMS, Patna
Patna
BIHAR
800014
India
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
bkpgunjankr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
swati |
| Designation |
Associate professor |
| Affiliation |
Institute of medical sciences, patna |
| Address |
Department of Anaesthesia, IGIMS, Patna
Patna
BIHAR
800014
India
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
swati |
| Designation |
Associate professor |
| Affiliation |
Institute of medical sciences, patna |
| Address |
Department of Anaesthesia, IGIMS, Patna
Patna
BIHAR
800014
India
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Patna, India |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of medical Sciences |
| Address |
IGIMS, Sheikhpura,Patna 800014 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| gunjan |
IGIMS Sheikhpura patna 800014 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| GUNJAN KUMAR |
Indira Gandhi Institute of Medical Sciences |
Department of Anaesthesia, OT Complex, First floor, IGIMS.
Patna
BIHAR
Patna
BIHAR |
7352360745
bkpgunjankr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Breast tumour, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae and bupivacaine |
Erector spinae block will be given, 20ml 0.25% bupivacaine will be injected behind the erector spinae muscle and analgesia would be monitored for postoperatively for 8 hours |
| Comparator Agent |
Erector spinae and bupivacaine |
Erector spinae block will be given, 20ml 0.25% bupivacaine will be injected behind the erector spinae muscle for 8 hours postoperatively |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Patients posted for breast surgery (Modified Radical Masectomy, Simple mastectomy, Lumpectomy)
ASA grade 1,2,3
|
|
| ExclusionCriteria |
| Details |
ASA grade 4
Any allergy to local anaesthetics
Patients refusal
Infection at site of intervention
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperatively for 24 hours total opioid consumption. |
Every 4 hours for 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sensory block - loss of cold sensation of anterior and posterior roots of thoracic spinal nerve dermatomes
Pain scores – numerical rating scores (NRS) will be used
|
pain score will be assessed every 2 hrs for 24 hrs. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2018 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
study yet not started so not sent for publication. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To see the effect of erector spinae plane block for postoperative analgesia in reducing morphine requirement after breast surgery. Patient would be monitored postoperatively every 4 hours on NRS Scale. There would be two group one would receive analgesia by erector spinae block other would be cantrol group. |