| CTRI Number |
CTRI/2020/06/025810 [Registered on: 11/06/2020] Trial Registered Prospectively |
| Last Modified On: |
12/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study between Two Drugs for Regional Anaesthesia using Ultrasound Guided Nerve Blocks through Perineural
Catheter for Postoperative Analgesia in Upper limb Surgeries |
|
Scientific Title of Study
|
Comparative study between 0.125 % Bupivacaine and 0.2 %
Ropivacaine in Ultrasound Guided Supraclavicular Brachial Plexus Block using Perineural
Catheter for Postoperative Analgesia 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 Syed Arafath Ahmed |
| Designation |
MD Anaesthesiology (Post Graduate Resident) |
| Affiliation |
Sri Manakula Vinayagar Medical College And Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
Sri Manakula Vinayagar Medical College and Hospital
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9551087861 |
| Fax |
|
| Email |
drahmed1216@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SureshKumar K |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
Sri Manakula Vinayagar Medical College and Hospital
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9884190530 |
| Fax |
|
| Email |
surekumk9292@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr SureshKumar K |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
Sri Manakula Vinayagar Medical College and Hospital
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9884190530 |
| Fax |
|
| Email |
surekumk9292@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Dr. Syed Arafath Ahmed(SELF)
Sri Manakula Vinayagar Medical College and Hospital,
Kalitheerthal Kuppam, Madagadipet,
Puducherry - 605107.
|
| Sri Manakula Vinayagar Medical College and Hospital,
Kalitheerthal Kuppam, Madagadipet,
Puducherry - 605107.
|
|
|
Primary Sponsor
|
| Name |
Dr Syed Arafath Ahmed |
| Address |
Department of Anaesthesiology and Critical Care,
Sri Manakula Vinayagar Medical College and Hospital
Kaltheerthalkuppam, Pondicherry - 605107. |
| 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 SYED ARAFATH AHMED |
Sri Manakula Vinyagar Medical College and Hospital |
Department of Anaesthesiology and Critical Care,
Sri Manakula Vinayagar Medical College and Hospital
Pondicherry
PONDICHERRY |
9551087861
drahmed1216@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BUPIVACAINE |
0.125 %, 30 mL, Through perineural catheter at the end of surgery |
| Intervention |
NOT APPLICABLE |
NOT APPLICABLE |
| Comparator Agent |
ROPIVACAINE |
0.2 %, 30 mL, Through perineural catheter at the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists(ASA) 1 and 2
Body Weight - 50-95 kg |
|
| ExclusionCriteria |
| Details |
Age less than 18years and age more than 65 years.
Pregnant women
Infection at the site of block
Patients with coagulopathy
History of allergy to local anaesthetic drugs
Mental incapacity or language barrier precluding to informed consent
Patient refusal
Pre existing motor or sensory deficit in the operative limb
Severe pulmonary pathology
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the duration of postoperative analgesia using Visual Analogue Scale (VAS) in both groups Group R (Ropivacaine) and Group B (Bupivacaine). |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the degree of motor blockade in both groups |
1.5 years |
| To assess the time of first rescue analgesia required |
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
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The proposed study is to
compare the effectiveness of two different local anaesthetic drugs (0.125%
Bupivacaine and 0.2% Ropivacaine) in the Post- operative Period after an
electively posted Upper Limb Surgery in patients satisfying the inclusion and
the exclusion criteria |