| CTRI Number |
CTRI/2019/01/017298 [Registered on: 28/01/2019] Trial Registered Prospectively |
| Last Modified On: |
25/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound guided modified PECs-II block versus ultrasound guided paravertebral block among patients undergoing conservative breast surgery: A pilot study |
|
Scientific Title of Study
|
Comparison of the efficacy of ultrasound guided modified Pectroalis (PECs-II) block and ultrasound guided lateral intercostal approach to paravertebral block among patients undergoing conservative breast surgery: A pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nihar Ameta |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of Anaesthesiology and Critical Care
Armed Forces Medical College, Solapur Road
Pune
MAHARASHTRA
411001
India |
| Phone |
8551055667 |
| Fax |
|
| Email |
nihar.ameta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nihar Ameta |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of Anaesthesiology and Critical Care
Armed Forces Medical College, Solapur Road
MAHARASHTRA
411001
India |
| Phone |
8551055667 |
| Fax |
|
| Email |
nihar.ameta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nihar Ameta |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of Anaesthesiology and Critical Care
Armed Forces Medical College, Solapur Road
MAHARASHTRA
411001
India |
| Phone |
8551055667 |
| Fax |
|
| Email |
nihar.ameta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nihar Ameta |
| Address |
Dept of Anaesthesiology, AFMC, Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Nihar Ameta |
Dept of Anaesthesiology and Critical Care, AFMC |
Dept of Anaesthesiology and Critical Care, Armed Forces Medical College, Solapur Road
Pune
MAHARASHTRA |
8551055667
nihar.ameta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AFMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Paravertebral Block |
Ultrasound guided lateral intercostal approach to paravertebral block |
| Intervention |
Ultrasound guided modified PECs-2 Block |
∞ The study is first of its kind comparing two novel ultrasound guided blocks utilized in conservative breast surgery.
a. Pre Anesthetic Evaluation, Preoperative informed consent obtained, Patient Education regarding pain score and satisfaction rating introduced.
b. Baseline monitoring Pre-medication with Inj. Glycopyrrolate (0.2mg i.v.), Inj. Fentanyl (2 microgram/kg)
c. Induction with propofol (1.5-2.5mg/kg i.v.) followed by Muscle relaxant with Inj. Atracurium (0.5-mg/kg i.v.) Maintenance with oxygen, nitrous oxide, inhalational anesthetic (sevoflurane)in 0.8 -1.2 MAC range and maintenance opioid fentanyl 1microgram/kg/hr.
d. Immediately after securing airway either with supraglottic airway device or with endotracheal tube, patient positioned either in supine position (for ultrasound guided pectoral block) or lateral position (for ultrasound guided intercostal paravertebral block) and receive 20ml of 0.25% bupivacaine by an an in-plane needle approach.
e. Postoperative pain scores evaluated immediate postoperatively (in PACU) followed by 2,6,12 and 24 hours.
f. Overall patient satisfaction assessment done. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Breast Lump: Benign or Malignant |
|
| ExclusionCriteria |
| Details |
Extensive breast surgery which includes axillary lymph node dissection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The goal of the study is to address the postoperative pain score and need for rescue analgesia after conservative breast surgery and comparison of novel ultrasound guided blocks. |
Immediate postoperative in recovery room.
2 hours postoperatively prior to shifting out of recovery room.
6 hours postoperatively in the ward.
12 hours postoperatively in the ward.
24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rescue analgesia and dose required |
Immediate postoperative in recovery room.
2 hours postoperatively prior to shifting out of recovery room.
6 hours postoperatively in the ward.
12 hours postoperatively in the ward.
24 hours postoperatively |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2019 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study targets patients of tertiary care hospital who will undergo conservative breast surgery who undergo performance of either ultrasound guided Pectoral block or ultrasound guided Intercostal approach to Paravertebral block. The goal of the study is to address the postoperative pain score and need for rescue analgesia after conservative breast surgery and comparison of novel ultrasound guided blocks. Patient satisfaction also will be taken into account postoperatively. |