| CTRI Number |
CTRI/2016/06/007047 [Registered on: 29/06/2016] Trial Registered Prospectively |
| Last Modified On: |
29/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of three different types of injections on the chest for pain relief in breast surgeries |
|
Scientific Title of Study
|
ultrasound guided paravertebral, pectoralis II and serratus anterior plane block in breast surgeries: spread of local anesthetic and post operative analgesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhruv jain |
| Designation |
Junior resident |
| Affiliation |
All india institute of medical sciences, New Delhi |
| Address |
Department of Anesthesiology,
AIIMS
H.No 575
sector 11-B
Chandigarh
South
DELHI
110029
India |
| Phone |
7042129423 |
| Fax |
|
| Email |
dhruvjn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Virender Kumar Mohan |
| Designation |
Professor |
| Affiliation |
All india institute of medical sciences, New Delhi |
| Address |
room no 5007
Department of Anesthesiology
5th floor, teaching block
AIIMS
South
DELHI
110029
India |
| Phone |
9868397803 |
| Fax |
|
| Email |
dr_vkmohan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhruv jain |
| Designation |
Junior resident |
| Affiliation |
All india institute of medical sciences, New Delhi |
| Address |
Department of Anesthesiology,
AIIMS
H.No 575
sector 11-B
Chandigarh
DELHI
110029
India |
| Phone |
7042129423 |
| Fax |
|
| Email |
dhruvjn@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar
New delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dhruv Jain |
All India Institute of Medical Sciences, New delhi |
room no 5007
Department of Anesthesia
AIIMS
South
DELHI |
7042129423
dhruvjn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee for post graduate research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
asa 1 and 2 patients scheduled for elective modified radical mastectomy, (1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
paravertebral block |
20 ml 0.375% ropivacaine single shot in paravertebral area |
| Intervention |
PECS II block |
30 ml 0.375% ropivacaine single shot between pectoral muscles |
| Intervention |
serratus anterior plane block |
30 ml 0.375% ropivacaine single shot below the serratus anterior muscle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 and 2 undergoing elective mastectomy surgeries |
|
| ExclusionCriteria |
| Details |
coagulopathy
BMI >35kg/m2
pregnancy
mental retardation
chest wall deformity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Find out the spread of local anesthetic radiographically and co-relate it with the sensory blockade produced.
2.To compare the post operative 24 hour fentanyl consumption.
|
1.radiographic spread seen immediately after injecting the drug. sensory block seen 15-30 minutes after injecting the drug
2.total fentalyl consumption seen at 24 hours after the surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Onset of sensory blockade
•Intra-operative opioid requirement
•Visual Analog Scale (VAS) scores for pain for 24 hours post operative period
•Time for first post operative analgesia requirement
•Incidence of post operative nausea and vomiting (PONV)
|
specified in the outcomes
Post operative nausea vomiting for 24 hours post op |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2016 |
| Date of Study Completion (India) |
28/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Breast surgeries are associated with significant post operative pain which may progress to chronic pain. Regional techniques reduce the postoperative acute pain which results in reduced morbidity and decreased consumption of opioids. Paravertebral block is commonly used for breast surgeries. However it is associated with many complications. Two new ultrasound guided interfascial plane blocks-PECS II and serratus plane block have been recently described which are more selective, have less complications and may provide better analgesia. There are no studies comparing these blocks for breast surgery. Also, evaluating the area of sensory blockade in large number of patients will help in describing the extent of blockade more accurately and their use may extend beyond breast surgeries. This study is designed to study about these new techniques under ultrasound guidance to ensure maximum safety and find their analgesic efficacy. Therefore, we hypothesize that · PECS II and serratus plane block will provide better analgesia than paravertebral block for breast surgeries with lesser side effects. · Serratus plane block will provide better sensory blockade and analgesia than PECS II block. |