| CTRI Number |
CTRI/2022/09/045396 [Registered on: 09/09/2022] Trial Registered Prospectively |
| Last Modified On: |
08/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Optimum dose finding study of 0.75% hyperbaric ropivacaine for unilateral subarachnoid block in lower limb orthopedic surgeries |
|
Scientific Title of Study
|
Dose finding study of 0.75% hyperbaric ropivacaine for unilateral subarachnoid block in lower limb orthopedic 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 Souvik Saha |
| Designation |
Assistant Professor |
| Affiliation |
Diamond Harbour Government Medical College and Hospital |
| Address |
Department of Anesthesiology, Diamond Harbour Government Medical College and Hospital,
Diamond Harbour Road, Harindanga,
Diamond Harbour
South Twentyfour Parganas
WEST BENGAL
743331
India |
| Phone |
8759132774 |
| Fax |
|
| Email |
souviksh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suchismita Pal |
| Designation |
Assistant Professor |
| Affiliation |
Diamond Harbour Government Medical College and Hospital |
| Address |
Department of Anesthesiology, Diamond Harbour Government Medical College and Hospital,
Diamond Harbour Road, Harindanga,
Diamond Harbour
South Twentyfour Parganas
WEST BENGAL
743331
India |
| Phone |
947459903 |
| Fax |
|
| Email |
suchiofficial21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suchismita Pal |
| Designation |
Assistant Professor |
| Affiliation |
Diamond Harbour Government Medical College and Hospital |
| Address |
Department of Anesthesiology, Diamond Harbour Government Medical College and Hospital,
Diamond Harbour Road, Harindanga,
Diamond Harbour
South Twentyfour Parganas
WEST BENGAL
743331
India |
| Phone |
947459903 |
| Fax |
|
| Email |
suchiofficial21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Diamond Harbour Government Medical college and Hospital,
Diamond Harbour Road, Harindanga,
Diamond Harbour, South 24 parganas, West Bengal, 743331 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
Diamond Harbour Government Medical college and Hospital,
Diamond Harbour Road, Harindanga,
Diamond Harbour, South 24 parganas, West Bengal, 743331 |
| 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 Suchismita Pal |
Operation theatre of Superspeciality hospital (SSH) builiding |
Diamond Harbour Government Medical College and Hospital, Diamond Harbour
South Twentyfour Parganas
WEST BENGAL |
9474599093
suchiofficial21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Diamond Harbour Govt. Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ropivacaine |
0.75% ropivacaine is used in 3 different doses (1ml, 1.5ml, 2ml) in 3 groups with 34 participants each to determine the ideal dose of unilateral subarachnoid block in lower limb orthopedic surgery |
| Comparator Agent |
ropivacaine |
3 doses 1ml, 1.5ml,2ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Body weight - 40-85 kg
Height - 150-180 cm
ASA 1, 2
Duration of surgery - less than 1 hour |
|
| ExclusionCriteria |
| Details |
Unwilling for subarachnoid block,
skin infection at the site of intrathecal injection,
allergy to the study drug,
coagulopathy,
taking anticoagulant drugs,
hypovolemia,
fixed cardiac output disease,
undetermined neurologic disease, spine deformity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the ideal dosage of hyperbaric 0.75% ropivacaine for unilateral subarachnoid block in orthopedic lower limb surgeries by assessing the maximum sensory and motor block o both operative and non operative sides by each individual dosage |
baseline, 20 minutes after the injection for subarachnoid block, 2 hours after the sbaracoid block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hemodynamic effects of the 3 different doses for unilateral subarachnoid block |
during the surgery |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
15/09/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Subarachnoid block is one of the important techniques of anesthesia for performing orthopedic lower limb surgeries as it can produce adequate sensory, motor and sympathetic block in a rapid manner. This can become more cost effective with unilateral block as hemodynamic effects, post operative urinary retention can be minimized leading to better patient satisfaction and faster discharge. Ropivacaine is an alternative to bupivacaine for subarachnoid block as it has less chance of cardiotoxicity as well as neurotoxicity. Although 0.5% Ropivacaine in isobaric or hyperbaric form has been used in lower limb surgeries , very less information is available regarding 0.75% Ropivacaine for unilateral block for orthopedic lower limb surgeries. The ideal dose of 0.75% ropivacaine for unilateral subarachnoid block for this type of orthopedic surgeries can be ascertained by assessing the maximum and minimum sensory and motor block on the operative and nonoperative sides and its effect on hemodynamics. |