| CTRI Number |
CTRI/2024/08/072579 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of upper limb block using Local Anaesthetic for orthopedic surgery |
|
Scientific Title of Study
|
To evaluate efficacy of hyaluronidase as an adjuvant to bupivacaine on the quality of brachial plexus block via sonar guided supraclavicular approach: A prospective randomized comparative study in department of Anesthesia ,sms medical college, jaipur . |
| 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 Sonali Beniwal |
| Designation |
Professor |
| Affiliation |
SMS medical college |
| Address |
Department of Anesthesiology, Second Floor, Dhanwantari Building, SMS medical college, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214540552 |
| Fax |
|
| Email |
drsonalisms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Beniwal |
| Designation |
Professor |
| Affiliation |
Sms medical college |
| Address |
Department of Anaesthesiology, Second Floor, Dhanwantari
Building, SMS Medical College, Jaipur Jaipur RAJASTHAN 302004
India
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214540552 |
| Fax |
|
| Email |
drsonalisms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rinki meena |
| Designation |
Junior resident |
| Affiliation |
SMS medical college jaipur |
| Address |
Department of Anaesthesiology, Second Floor, Dhanwantari
Building, SMS Medical College, Jaipur Jaipur RAJASTHAN 302004
India
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
9057311863 |
| Fax |
|
| Email |
Rinkibadjatiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Second Floor, Dhanwantari
Building, SMS Medical College, Jaipur Jaipur RAJASTHAN 302004
India
RAJASTHAN
302004
India |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and attached Hospitals jaipur |
| Address |
Department of Anaesthesiology, Second Floor, Dhanwantari
Building, SMS Medical College, Jaipur Jaipur RAJASTHAN 302004
India
RAJASTHAN
302004
India |
| 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 |
| Rinki meena |
SMS Medical College and attached Hospitals, Jaipur |
Second Floor, Dhanvantri Building, Orthopedic operation theater, SMS medical college and hospital,Jaipur
Jaipur
RAJASTHAN |
9057311863
Rinkibadjatiya@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics committee,SMS Medical college and attached hospitals,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brachial plexus block by supraclavicular approach. |
Patient will receive 25 ml of 0.5% plain Bupivacaine by single injection technique. Total volume 25 ml. |
| Comparator Agent |
Brachial plexus block by supraclavicular approach. |
Patients will receive 15 ml of 0.5% plain Bupivacaine + 0.9% (5 ml) sterile normal saline containing 500 IU(100 IU/ml) Hyaluronidase by single injection technique.Total volume of 20 ml.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing elective upper limb surgeries. Patients willing to participate with written informed concent Patient of either sex
All Adults
American Society of Anesthesiologists(ASA) grade 1 and 2
Body weight between 40-70 kg.
|
|
| ExclusionCriteria |
| Details |
Case with sepsis, bacteremia or skin infection of local site History of severe hypovolemia, anemia and compromised
Renal ,cardiac and respiratory system
Patient allergic to drugs used for study. Failure of supraclavicular block cases in which general Anesthesia will be required.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean of Onset of sensory block (minutes)
Mean of Onset of motor block (minutes) Mean Duration of motor block (minutes) Proportion of Rate of success of block Mean Duration of analgesia (minutes) Mean Hemodynamic parameters Proportion of cases having Complication( if any)
|
Baseline,
2 min
5 min
10 min
15 min
30 min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean of Onset of sensory block (minutes)
Mean of Onset of motor block (minutes) Mean Duration of motor block (minutes) Proportion of Rate of success of block Mean Duration of analgesia (minutes) Mean Hemodynamic parameters Proportion of cases having Complication( if any)
|
Baseline
2 min
5min
10min
15min
30min |
|
|
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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Then 60 Patients will be randomly allocated into two equal groups each of 30 patients: in group I, patients received 25 ml plain bupivacaine 0.5% by single-injection technique while in group II, patients received 15 ml volume [15 ml 0.5% bupivacaine plus 5 ml 0.9% normal saline containing 500 IU (100 IU/ml) hyaluronidase total of 20 ml by single-injection technique. Hyaluronidase will be prepared by diluting the vial of hyaluronidase (1500 IU) in 15 ml normal saline 0.9%. and its 5 ml volume is mixed with bupivacaine in group II The local anesthetic solution will be prepared by an anesthesiologist . Monitoring of all parameters will be done by an anesthesiologist . Time of onset of sensory and motor blocks, success rate of block will be noted along with duration of motor block , the total duration of analgesia and side effects if any.
|