| CTRI Number |
CTRI/2021/03/032296 [Registered on: 25/03/2021] Trial Registered Prospectively |
| Last Modified On: |
24/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effectiveness of infraclavicular brachial plexus block using bupivacaine alone with bupivacaine with dexmedetomidine for pain control in patients undergoing upper limb surgeries. |
|
Scientific Title of Study
|
Comparison of effectiveness of ultrasound guided single injection infraclavicular brachial plexus block using bupivacaine alone with bupivacaine combined with dexmedetomidine for pain control in upper limb surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Patil |
| Designation |
Post graduate medical student |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anaesthesiology. Bangalore medical college and research institute. Fort Road. K.R market . Bengaluru 560002
Department of anaesthesiology. Bangalore medical college and research institute . K.R. Market .Bengaluru. 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9620610915 |
| Fax |
|
| Email |
patildrpoojas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saraswathi N |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anaesthesiology. Bangalore medical college and research institute. K r market. Bengaluru
Department of anaesthesiology. Bangalore medical college and research institute. K r market. Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saraswathi N |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anaesthesiology. Bangalore medical college and research institute. K r market. Bengaluru
Department of anaesthesiology. Bangalore medical college and research institute. K r market. Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Banaglore medical college and research institute |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Patil |
| Address |
Bangalore medical college and Research institute ladies hostel. K r market. Bengaluru |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Pooja Patil |
Department of anaesthesiology,
Bangalore medical college and research institute.
K r market
Bengaluru.560002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja Patil |
Bangalore medical college and research institute |
Department of anaesthesiology. Banaglore medical college and research institute, Bengaluru
Bangalore
KARNATAKA |
9620610915
patildrpoojas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BMCRI ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S52||Fracture of forearm, (2) ICD-10 Condition: S423||Fracture of shaft of humerus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Infraclavicular block using bupivacaine |
30 ml of 0.33% bupivacaine with placebo |
| Comparator Agent |
Infraclavicular block using bupivacaine with dexmedetomidine |
30ml of 0.33% bupivacaine + 1mcg/kg of dexmedetomidine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have given informed and written consent
2. Patients belonging to ASA1 and ASA2 category
3. Patients aged 18-60 years |
|
| ExclusionCriteria |
| Details |
1. Patients refusing to take part in study
2. History of allergy to local anaesthetic
3. Infection at block site
4. Patients with bleeding disorder and abnormal coagulation profile
5. Patients with sensory or motor deficits in the limb before surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Onset and duration of sensory and motor blockade
2. Duration of analgesia |
Intra operative and Post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Supplemental opioid requirement and sedation score |
Intraoperative and postoperative period |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/03/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
This is a prospective randomised double-blind study comparing the effectiveness of ultrasound guided infraclavicular brachial plexus block using bupivacaine alone with bupivacaine combined with dexmedetomidine in patients undergoing upper limb surgries. It wil be conducted in a total of 50 patients, 25 in each group, in all the hospitals attached to Bangalore Medical College and Research Institute. Primary outcome is to measure the onset and duration of sensory and motor blockade and secondary outcome is duration of analgesia and sedation score including postoperative period. |