| CTRI Number |
CTRI/2024/08/072236 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare which concentration of drug levobupivacaine used for pectoralis block is better for pain relief in patients undergoing breast surgeries for breast cancer. |
|
Scientific Title of Study
|
Comparative evaluation of ultrasound guided PECS block of the two concentration of levobupivacaine with adjuvant dexmedetomidine in patients undergoing modified radical mastectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MANOJ KUMAR PANWAR |
| Designation |
Professor |
| Affiliation |
Professor at the department of anesthesiology, Indira Gandhi Medical College, Shimla. |
| Address |
Department Of Anesthesiology, Indira Gandhi Medical College,
Shimla, Himachal Pradesh, India,
Pin code :171001.
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418086876 |
| Fax |
|
| Email |
drmkpanwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr HARIKRISHNA S |
| Designation |
Junior resident |
| Affiliation |
Junior resident at the department of anesthesiology, Indira Gandhi Medical College, Shimla. |
| Address |
Department Of Anesthesiology, Indira Gandhi Medical College,
Shimla, Himachal Pradesh, India,
Pin code :171001.
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7012162967 |
| Fax |
|
| Email |
harikaithot007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MANOJ KUMAR PANWAR |
| Designation |
Professor |
| Affiliation |
Professor at the department of anesthesiology, Indira Gandhi Medical College, Shimla. |
| Address |
Department Of Anesthesiology, Indira Gandhi Medical College,
Shimla, Himachal Pradesh, India,
Pin code :171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418086876 |
| Fax |
|
| Email |
drmkpanwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology, Indira Gandhi Medical College,
Ridge - Sanjauli Road, Lakkar Bazar, Shimla, Himachal Pradesh ,India , Pin code: 171001 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College |
| Address |
Ridge Sanjauli Road, Lakkar Bazar, Shimla, Himachal Pradesh -
171001 |
| 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 |
| Dr Prof MANOJ KUMAR PANWAR |
Indira Gandhi Medical College, Shimla, Himachal Pradesh, India |
Department Of Anesthesiology, Indira Gandhi Medical College,
Shimla, Himachal Pradesh, India,
Pin code :171001
Shimla
HIMACHAL PRADESH |
9418086876
drmkpanwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi Medical College, Shimla |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Compare the efficacy of two different concentration of levobupivacaine with adjuvant dexmedetomidine used in ultrasound guided pectoralis nerve block. |
In the present study, our main objective was to compare the efficacy of levobupivacaine 0.125% adjuvant (dexmedetomidine) with levobupivacaine 0.25% adjuvant (dexmedetomidine) in an ultrasound-guided PEC Block as analgesia during a 24-hr period after MRM. Our secondary aim will be to investigate whether the PEC Block reduced the amount of analgesia used postoperatively.
Post operative monitoring will be carried out in the recovery room and the postoperative ward. The duration of analgesia will be noted according to “visual analogue scale for pain†at 30 mins,1hr, 2hrs,4 hrs, 6hrs, 12hrs and 24hrs after surgery. When the patient complained of pain (Visual Analogue Score of 4), it will be considered that the analgesic action of the drug has been terminated. Patient will be given rescue analgesic in the form of
Injection diclofenac sodium .If there is break through pain before 8 hours , Injection tramadol will be given as second rescue analgesia. |
| Intervention |
Ultrasound guided pectoralis nerve block |
A prospective, comparative, randomized single blind study, Comparative evaluation of ultrasound guided PECS block of the two concentration of levobupivacaine with adjuvant dexmedetomidine in patients undergoing modified radical mastectomy for post operative analgesia , after carcinoma beast surgery. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1.
Age group in between 30 and 80 years, diagnosed with stage I and II breast carcinoma.
2.
ASA I and II patients.
3.
In patients whom consented for the procedure.
4.
Patients with normal coagulation profile. |
|
| ExclusionCriteria |
| Details |
1.
Patient with chest wall / spine deformities.
2.
Pregnancy.
3.
Change in the procedure planed ; that is if initially the patient was planed for MRM later changed to more invasive procedure on table. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the efficacy of levobupivacaine 0.125% adjuvant (dexmedetomidine) with levobupivacaine 0.25% adjuvant (dexmedetomidine) in an ultrasound-guided PEC Block as analgesia during a 24-hr period after MRM. |
24 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the requirement for rescue
analgesia in both groups |
24 hours |
| Whether the PEC Block reduced the amount of analgesia used postoperatively. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 common cancer in the women worldwide. Mastectomy is the treatment of choice for carcinoma breast stage-I and -II with tumours not involving the chest-muscle fascia. Modified radical mastectomy (MRM) involves removal of the whole breast which includes the skin, areola, nipple, and most axillary lymph nodes. During mastectomy, some of the nerves in the chest are severed. Most women have some level of pain after the procedure. Severe acute postoperative pain following breast surgery not only increases the risk of persistent pain and affects recovery, it also leads to longer hospitalization and increased healthcare costs. Pectoral nerve block can provide a good analgesic effect for pain after carcinoma breast surgery. PECS blocks have also been proposed as alternative techniques to anesthetize operative regions such as the axilla, proximal medial upper arm, and posterior shoulder. In our study we are planning to give PECS block before induction of general anesthesia in two different concentration of levobupivacaine with adjuvant (dexmedetomidine).We will look which concentration of levobupivacaine with adjuvant (dexmedetomidine) will be better for postoperative analgesia . |