| CTRI Number |
CTRI/2020/06/025823 [Registered on: 11/06/2020] Trial Registered Prospectively |
| Last Modified On: |
13/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study of safety and efficacy of a local anaesthesia combined with two different adjuvants ; given as USG guided nerve block, in patients
undergoing upper limb orthopaedic surgery.†|
|
Scientific Title of Study
|
“A comparative study of safety and efficacy of 0.5%
Ropivacaine combined with either Dexmedetomidine or
Clonidine as adjuvant ; given as USG guided
supraclavicular brachial plexus block, in patients
undergoing elective upper limb orthopaedic surgery.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali Singh |
| Designation |
post graduate student |
| Affiliation |
Dr S. N. Medical college, jodhpur |
| Address |
Department of Anaesthesiology and Critical Care
Dr S.N.Medical College Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
8584998411 |
| Fax |
|
| Email |
dranjalisingh57@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Fateh Singh Bhati |
| Designation |
Professor |
| Affiliation |
Dr S. N. Medical college, jodhpur |
| Address |
Department of Anaesthesiology and Critical Care
Dr S.N.Medical College Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9414127176 |
| Fax |
|
| Email |
fatehbhati@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Singh |
| Designation |
Post graduate Student |
| Affiliation |
Dr S.N. Medical College, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care
Dr S.N.Medical College Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
8584998411 |
| Fax |
|
| Email |
dranjalisingh57@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S.N.Medical College Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sampurnanand Medical College |
| Address |
Dr S.N.Medical College Jodhpur
shastri nagar residency road
Jodhpur (Rajasthan)342003 |
| 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 Anjali Singh |
Dr S.N. Medical College and associate group of hospital |
Shastri nagar
Jodhpur
RAJASTHAN |
8584998411
dranjalisingh57@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee,Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ropivacaine with clonidine |
Patients who will receive 29ml ropivacaine 0.5% and 1ml clonidine(50mcg) |
| Comparator Agent |
Ropivacaine with dexmedetomidine |
Patient who will receive 29ml ropivacaine 0.5% and 1ml dexmedetomidine(50mcg) |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & II of body weight 30 to 80 kg, undergoing upperlimb orthopaedic surgery of less than two hours duration.
Free from any associated chronic systemic illness. |
|
| ExclusionCriteria |
| Details |
Uncooperative patient
Pregnant or lactating mother
Neurological deficit in operative limb with chronic pain or on long term analgesics
Patient having hypersensitivity or contraindication to Ropivacaine/ Dexmedetomidine/ Clonidine
Local pathology at the site of injection
All disability limiting the performance of block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the duration of analgesia,onset of sensory and motor block of
0.5% Ropivacaine combined with either Dexmedetomidine or Clonidine
as adjuvants injected perineurally.
2. Number of Rescue analgesic given in 24 hours in both groups
3. Total dose of rescue medication consumption (tramadol and Diclofenac)
in 24 hrs. |
Assessment of block quality by calculation of composite score of bromage scale and duration of analgesia was recorded by patient response. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. NRS pain scores at rest (NRS-R) & at movement (passive/active) NRS-M
of operated upper limb in first 24 hours.
2. Patient’s satisfaction score.
3. Any complications / adverse effects/side effects of block.
4. Any changes inNIBP,PR&SpO 2 in first 24 hours. |
Assessment of block quality by calculation of composite score of bromage scale and duration of analgesia was recorded by patient response. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/06/2020 |
| Date of Study Completion (India) |
13/11/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Post-operatively regional anaesthesia is of great value to treat pain following surgery and to minimize the use of opiods. Long acting local anaesthetic like Ropivacaine used for regional anaesthesia. Addition of an adjuvant to local anaesthetic can further have the advantage of prolonging the duration of block and post operative analgesia. In recent years supraclavicular brachial plexus block has gained popularity with addition of various adjuvant to anaesthetic solution. Present study we have taken two alpha receptor agonist Clonidin and Dexmeditomidine as adjuvant to Ropivacaine. We aim to discover which is more superior regarding safety and efficacy.
|