| CTRI Number |
CTRI/2025/04/085646 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| 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
|
We are trying to see the effect of fentanyl and dexmedetomidine as an additive drug to levobupivacine in blocking the nerves in thoracic area present in paravertebral space in cases of modified breast surgery to see pain relief after operation. |
|
Scientific Title of Study
|
Effect of fentanyl and dexmedetomidine as an adjuvant to levobupivacaine in paravertebral block for post operative analgesia in the patient undergoing modified radical mastectomy: A prospective randomised double blind study |
| 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 Nafis Anwar |
| Designation |
Post graduation resident |
| Affiliation |
Rajendra Institute Of medical sciences |
| Address |
Department of Anaesthesiology RIMS Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
7870929552 |
| Fax |
|
| Email |
anwarnafis99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwanath Kumar |
| Designation |
Associate Professor Department of Anaesthesiology RIMS Ranchi |
| Affiliation |
Rajendra institute of medical sciences Ranchi |
| Address |
Department of Anaesthesiology RIMS Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8439512490 |
| Fax |
|
| Email |
drvishwanathkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharati |
| Designation |
Assistant Professor Department of Anaesthesiology RIMS Ranchi |
| Affiliation |
Rajendra institute of medical sciences |
| Address |
Department of Anaesthesiology RIMS Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9599277395 |
| Fax |
|
| Email |
bharati.bediya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra institute of medical sciences Bariyatu Ranchi Jharkhand India 834009 |
|
|
Primary Sponsor
|
| Name |
Dr Nafis Anwar |
| Address |
Department of Anaesthesiology RIMS Ranchi Jharkhand India 834009 |
| 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 Nafis Anwar |
Rajendra institute of medical sciences Ranchi Jharkhand India 834009 |
Room no 1 Department of Anaesthesiology RIMS Ranchi Jharkhand India 834009
Ranchi
JHARKHAND |
7870929552
anwarnafis99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee RIMS Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Paravertebral block |
Effect of fentanyl as an adjuvant to levobupivacaine in paravertebral block for post operative analgesia in Modified radical mastectomy patients |
| Comparator Agent |
paravertebral block |
Use of Dexmedetomidine as an adjuvant to Levobupivacaine in paravertebral block for post operative analgesia in the patient undergoing modified radical mastectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade I and II
Modified radical mastectomy surgery requiring general anaesthesia
Written and informed consent from patient
BMI 20 to 25 kg/meter square |
|
| ExclusionCriteria |
| Details |
Patient not giving consent
Hypersensitivity to either study drug
Patient having spinal deformity
Infection at the site of block
Patient having coagulopathy pregnancy and severe cardiopulmonary disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare time for first rescue analgesic request |
Till 24 hrs from successful paravertebral block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare Visual analogue scale score for pain & total analgesic consumption
To compare side effects like Sedation nausea vomiting bradycardia & hypotension in the post operative period till 24 hours |
Till 24 hrs from the time of successful paravertebral block |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
10/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
We will compare the effect of fentanyl and dexmedetomidine as an adjuvant to levobupivacaine for post operative analgesia in paravertebral block in cases of modified radical mastectomy
Purpose of trial is to minimise the use of intravenous analgesic agent to prevent the incidence of post operative nausea and vomiting thus reducing the duration of hospital stay and patient morbidity |