| CTRI Number |
CTRI/2021/01/030500 [Registered on: 15/01/2021] Trial Registered Prospectively |
| Last Modified On: |
10/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare two drugs when used with a local anesthetic for upper limb surgeries |
|
Scientific Title of Study
|
Comparative study between Tramadol and Butorphanol as an adjuvant to Bupivacaine for supraclavicular brachial plexus block. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Niyati Garg |
| Designation |
post graduate trainee 1st year |
| Affiliation |
kalinga institue of medical sciences |
| Address |
KIMS girls hostel, B Block,campus 5, KIIT university, Patia, Distt Khorda, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9958787244 |
| Fax |
|
| Email |
gargn58@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Brig Dr Ganesh Chandra Satapathy |
| Designation |
Prof & HOD, Dept of anesthesiology, KIMS, bhubaneswar |
| Affiliation |
kalinga institue of medical sciences, bhubaneswar |
| Address |
Department of Anesthesia, Kalinga Institute of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8283872939 |
| Fax |
|
| Email |
ganesh.satapathy@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Niyati Garg |
| Designation |
post graduate trainee 1st year |
| Affiliation |
kalinga institue of medical sciences |
| Address |
Department of Anaesthesiology, KIMS girls hostel, B block campus 5, KIIT university, Patia, Distt Khorda, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
|
| Fax |
|
| Email |
gargn58@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
KIMS girls hostel, campus 5 KIIT university, Patia Distt Khorda, Bhubaneswar |
| 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 |
| Niyati Garg |
Kalinga Institute of Medical Sciences |
Department of Anaesthesiology, KIIT campus 5, B Block, Patia, distt Khorda, Bhubaneswar-751024
Khordha
ORISSA |
9958787244
gargn58@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
supraclavicular block |
frequency-once
route of administration- supraclavicular under ultrasound guidance
dose- 1.Group T will receive 0.5% Bupivacaine 25 mL with 50 mg Tramadol (1 mL) titrated to 30 mL, and
2.Group B will receive 0.5% Bupivacaine 25 mL with 1 mg Butorphanol (1 mL) titrated to 30 mL
|
| Intervention |
supraclavicular brachial plexus block |
Two opioid adjuvants will be added to local anesthetic in supraclavicular block for post operative pain management |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA-PS I and II patients posted for upper limb orthopedic surgeries under Supraclavicular brachial plexus block.
|
|
| ExclusionCriteria |
| Details |
Patient refusal,
Morbidly obese patients (body mass index >35 kg/m2),
Pregnant or lactating women,
Allergy or addiction to study drugs,
Patients receiving chronic analgesic therapy,
Coagulopathies, and
Pre-existing peripheral neuropathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the onset and duration of sensory and motor blockade.
|
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study duration of postoperative analgesia, requirements of rescue analgesia, and drug-related adverse effects in Supraclavicular Brachial plexus block. |
1.5 years |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
21/01/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Brachial plexus block is widely used as an alternative to general anesthesia for upper limb surgeries. In this study, one group will receive Tramadol with Bupivacaine and the second group will receive Butorphanol with Bupivacaine. Both groups will be compared on the basis of onset and duration of motor and sensory block, duration of post operative analgesia, requirements of rescue analgesia and drug related adverse effects. |