| CTRI Number |
CTRI/2021/03/031781 [Registered on: 08/03/2021] Trial Registered Prospectively |
| Last Modified On: |
11/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Process of Care Changes
Other (Specify) [Analgesia] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare pain relief after giving analgesic injections using dexamethasone as additive to ropivacaine vs plain ropivacaine in chest wall muscle layers in patients undergoing breast
surgery. |
|
Scientific Title of Study
|
To compare the analgesic efficacy of ultrasound guided PEC II block using dexamethasone as an adjuvant to ropivacaine vs plain ropivacaine in patients undergoing modified radical mastectomy: a prospective, randomized, double blind, parallel group controlled clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Porika Prashanth Nayak |
| Designation |
PG-JR |
| Affiliation |
All India Institute Of Medical Sciences, RAIPUR |
| Address |
A-Block OT,4th floor
Department of Anesthesiology, Pain and Critical care,
AIIMS, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8328109536 |
| Fax |
|
| Email |
prashnayak123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Ramchandani |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences, RAIPUR |
| Address |
Department of Anaesthesiology
All India Institute of Medical Sciences
Raipur, (Chhattisgarh) India.
Raipur
CHHATTISGARH
492099
India |
| Phone |
94242-04244 |
| Fax |
|
| Email |
drsaritaramchandani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Porika Prashanth Nayak |
| Designation |
PG-JR |
| Affiliation |
All India Institute Of Medical Sciences, RAIPUR |
| Address |
A-Block OT, 4th Floor,
Department of anesthesiology,
AIIMS, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8328109536 |
| Fax |
|
| Email |
prashnayak123@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Tatibandh, Raipur,
Chattissgarh. 492099 |
|
|
Primary Sponsor
|
| Name |
Dr Porika Prashanth Nayak |
| Address |
A-Block OT, 4th Floor,
Department of Anesthesiology, AIIMS, RAIPUR. |
| 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 |
| Dr Porika Prashanth Nayak |
All india institute of medical sciences, Raipur |
A-Block OT, 4th Floor,
Department of Anesthesiology.
Raipur
CHHATTISGARH |
8328109536
prashnayak123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
Adding 8 mg dexamethasone as an adjuvant to 0.2% ropivacaine vs plain 0.2% ropivacaine in patients undergoing modified radical mastectomy |
| Comparator Agent |
Plain ropivacaine |
Adding 8 mg dexamethasone as an adjuvant to 0.2% ropivacaine vs plain 0.2% ropivacaine in patients undergoing modified radical mastectomy
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1)Female patients aged 18 years and above
2)Posted for unilateral elective MRM
3)Belonging to American society of Anaesthesiologists (ASA) grade I, II, III
|
|
| ExclusionCriteria |
| Details |
1)Patients refusal.
2)Contraindications to regional anesthesia (RA) (bleeding diathesis, infection at the site of block and peripheral neuropathy).
3)Allergy to study drugs.
4)BMI ≥ 35 kg/m2 or body weight ≤ less than 40kg.
5)Chest wall deformity.
6)Patients who have undergone prior breast surgery.
7)Psychiatric patients.
8)Pregnant and lactating patients.
9)Any untoward major intra-operative complication (if any). (severe hypotension, bradycardia any injury to the nerve related to the block)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total opioid consumption till 12 hours post-operatively. |
0 hours(when patient arrived at post-operative care unit), 2 hours, 4 hours, 6 hours and 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Difference in pain scores post-operatively in first 12 hours using numeric rating scale (NRS).
2)Post-operative sedation scores.
3)Incidence and severity of post-operative nausea and vomiting (PONV).
4)Other adverse events (if any).
|
0 hours, 2 hours, 4 hours, 6 hours, 12 hours post-operatively. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
12/03/2021 |
| Date of Study Completion (India) |
29/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
· PECS is a new interfascial block
technique used for providing effective analgesia in the intra-op and post-op
period in various anterior thoracic wall surgeries.
· We hypothesized that addition of
dexamethasone as an adjuvant to ropivacaine using US guided PEC block technique
in patients undergoing MRM will prolong the duration and quality of analgesia
as compared to that of ropivacaine plain thus reducing overall opioid consumption
and incidence of side effects associated with opioid administration.
·
A total of 64 patients undergoing elective MRM were
randomized to two Groups, Group-A and Group-B. Group A (Study group) received
0.25% ropivacaine 30 ml+ dexamethasone 8mg (2ml) while Group B (Control
group):0.25% ropivacaine 30 ml + 2ml Normal saline (NS).
· The data
obtained was analysed.
·
The demographic variables like age, weight,
height, BMI were comparable across the groups and the differences were not
statistically significant.
·
The NRS Score when compared between Group A and
Group B was found to be statistically significant at 2, 4, 6 and 12 hrs in the
post-operative period, NRS score being higher in Group B.
·
There
was a significant difference between the two
groups in terms of Post-Operative Morphine consumption (p = <0.001), with the mean Post-Operative Morphine
consumption being highest in the Group B.
·
There was no significant difference between both the groups in
terms of associated side effects like hypotension, Bradycardia and nausea.
·
PECS II provides effective and good quality
analgesia in patients undergoing elective unilateral MRM with minimal side
effects and complications.
|