| CTRI Number |
CTRI/2023/11/060226 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
14/11/2023 |
| 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
|
A comparative study between hyperbaric ropivacaine and isobaric ropivacaine foe spinal anesthesia |
|
Scientific Title of Study
|
A comparative study of intrathecal hyperbaric ropivacaine and isobaric ropivacaine in patients undergoing hip surgeries-A prospective randomised study |
| 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 Sunkesula Sonia Begum |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College Kadapa |
| Address |
Department of anesthesia
government medical college
kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
8897573489 |
| Fax |
|
| Email |
sonia.sunkesula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunkesula Sonia Begum |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College Kadapa |
| Address |
Department of anesthesia
government medical college
kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
8897573489 |
| Fax |
|
| Email |
sonia.sunkesula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunkesula Sonia Begum |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College Kadapa |
| Address |
Department of anesthesia
government medical college
kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
8897573489 |
| Fax |
|
| Email |
sonia.sunkesula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology
government medical college
kadapa |
|
|
Primary Sponsor
|
| Name |
Dr Sunil Chiruvella |
| Address |
Department of anesthesiology
Government medical college
kadapa |
| Type of Sponsor |
Other [] |
|
|
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 SUNKESULA SONIA BEGUM |
Government General Hospital |
Government general hospital
Puttlampalli
Kadapa
Cuddapah
ANDHRA PRADESH |
8897573489
sonia.sunkesula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, KADAPA |
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 |
| Comparator Agent |
0.5% Hyperbaric Ropivacaine |
comparision of 15mg of 0.5% hyperbaric ropivacaine and 15mg of 0.5% isobaric ropivacaine in two group |
| Intervention |
0.5% Isobaric Ropivacaine |
comparision of 15mg of 0.5% hyperbaric ropivacaine and 15mg of 0.5% isobaric ropivacaine in two group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Allergic to local anaesthetics
Pregnancy
Absolute contraindications for Regional anesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary objective is to compare onset and duration of sensory and motor blockade |
5 mins
10 mins
15 mins
30 mins
1 hour
2 hours
6 hours
12 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary objective is to compare hemodynamic changes, intraoperative analgesia requirement and adverse effects in both groups |
5 mins
10 mins
15 mins
30 mins
1 hour
2 hours
6 hours
12 hours
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Various local anesthetics commonly used for spinal anesthesia . Nowadays Ropivacaine is gaining increasing popularity because of reduced risk of central nervous system and cardiac toxicity , early ambulation and discharge with good quality of postoperative analgesia .Hyperbaric ropivacaine produces more reliable sensory and motor blockade with faster onset, better quality of muscle relaxation than isobaric ropivacaine . The aim of the study is to compare the efficacy of hyperbaric and isobaric ropivacaine in patients undergoing hip surgeries. A randomised double blind study will be conducted in 60 patients of either sex undergoing hip surgeries will be divided into two groups A (30) and B (30) who will receive 15mg of 0.5% hyperbaric ropivacaine and 15mg of 0.5% isobaric ropivacaine respectively. |