| CTRI Number |
CTRI/2017/05/008446 [Registered on: 02/05/2017] Trial Registered Prospectively |
| Last Modified On: |
31/08/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the duration of pain relief after hand and forearm surgeries done under regional anaesthesia with ropivacaine versus levobupivacaine (local anaesthetic drugs). |
|
Scientific Title of Study
|
Comparative evaluation of duration of post operative analgesia and block characteristics with 0.5% ropivacaine versus 0.5% levobupivacaine in axillary brachial plexus blocks for isolated upper limb injuries, a double blinded prospective clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ARathna |
| Designation |
Professor(Anaesthesiology) |
| Affiliation |
Saveetha Medical College Chennai |
| Address |
Professor
Department of Anaesthesiology
Saveetha medical college
Chennai
Professor
Department of Anaesthesiology
Saveetha medical college
Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9940475385 |
| Fax |
|
| Email |
drrathna86@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ARathna |
| Designation |
Professor(Anaesthesiology) |
| Affiliation |
Saveetha Medical College Chennai |
| Address |
Professor
Department of Anaesthesiology
Saveetha medical college
Chennai
Professor(Anaesthesiology)
Department of Anaesthesiology
Saveetha medical college
Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9940475385 |
| Fax |
|
| Email |
drrathna86@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr ARathna |
| Designation |
Professor(Anaesthesiology) |
| Affiliation |
Saveetha Medical College Chennai |
| Address |
Professor(Anaesthesiology)
Department of Anaesthesiology
Saveetha medical college
Chennai
Professor(Anaesthesiology)
Department of Anaesthesiology
Saveetha medical college
Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9940475385 |
| Fax |
|
| Email |
drrathna86@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr A.Rathna
Professor ,Department of Anaesthesiology
Saveetha Medical College
Chennai-602105 |
|
|
Primary Sponsor
|
| Name |
Dr ARathna |
| Address |
Professor
Department of Anaesthesiology
Saveetha medical college
|
| 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 ARathna |
Saveetha Medical College Hospital |
Second Floor OT complex
OT NO-8
Saveetha Medical College Hospital
Kancheepuram
TAMIL NADU |
9940475385
drrathna86@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Saveetha University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients aged between 20 to 65 years with isolated upper limb injuries belonging to ASA I and ASA II class., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1.Ropivacaine 0.5%- local anaesthetic agent
2.Levobupivacaine 0.5%- local anaesthetic agent
|
1.Ropivacaine 0.5%- local anaesthetic agent
Route-perineural around brachial plexus through axillary route
Dose- 25 ml of 0.5% ropivacaine
Frequency- Single dose
Duration - Throughout surgery and till first 24 hours postoperatively the duration of motor block, sensory block and analgesia shall be monitored
2.Levobupivacaine 0.5%- local anaesthetic agent
Route-perineural around brachial plexus through axillary route
Dose- 25 ml of 0.5% ropivacaine
Frequency- Single dose
Duration - Throughout surgery and till first 24 hours postoperatively the duration of motor block, sensory block and analgesia shall be monitored |
| Intervention |
Axillary brachial plexus block |
The brachial plexus is blocked through axillary route under ultrasound guidance in the operation theater under sterile aseptic precautions for administering anaesthesia. The patient is connected to a monitor and heart rate, blood pressure and peripheral oxygen saturation are monitored. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Isolated forearm and hand injuries.
2 Age group of 20 -65yrs belonging to ASA I and ASA II groups.
|
|
| ExclusionCriteria |
| Details |
1 Patients with known hypersensitivity to local anaesthetics, coagulopathy, infection at the site of block, peripheral neuropathy
2 Patient refusal
3 Age group below 20 and above 65 are excluded
Belonging to ASA III, IV
4. Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Duration of analgesia
2.Assessment of sensory and motor block characteristics |
first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| safety of both drugs |
first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2017 |
| Date of Study Completion (India) |
23/08/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title-Comparative evaluation of duration of post operative analgesia and block characteristics with 0.5% ropivacaine versus 0.5% levobupivacaine in axillary brachial plexus blocks for isolated upper limb injuries, a double blinded prospective clinical study. Aims and objectives-To provide an effective method of post operative analgesia with safe drugs and reducing the need for systemic analgesics, early ambulation and less hospital stay. Methodology and design- A prospective randomised , double- blinded study shall be conducted on 60 patients aged 20 to 65 years of either sex belonging to ASA I and ASA 2 with isolated upper limb injuries after getting informed consent. The study shall be carried out in OT complex , theater 8 of Saveetha Medical College hospital. Pregnant and lactating women ,those with neuropathies or coagulopathies, those with known allergies to the drugs and those belonging to ASA 3 or above, aged below 20 years or above 65 years shall be excluded.
|