| CTRI Number |
CTRI/2021/05/033578 [Registered on: 12/05/2021] Trial Registered Prospectively |
| Last Modified On: |
09/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
a clinical trial to study the effects of two pain relief drugs,nalbuphine and butorphanol added to ropivacaine ,a numbing drug injected at the lower back into a space that carries nerves in patients undergoing lower extremity broken bone surgeries. |
|
Scientific Title of Study
|
A Randomised double blind control study of the analgesic efficacy of intrathecal nalbuphine and butorphanol as adjuvants to isobaric 0.5% Ropivacaine in lower limb orthopaedic 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 A Ilakya |
| Designation |
First year post graduate resident |
| Affiliation |
Melmaruvathur Adhiparasakthi institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology,Melmaruvathur Adhiparasakthi institute of Medical Sciences and Research,Melmaruvathur,kancheepuram District,Tamilnadu 603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9176738810 |
| Fax |
|
| Email |
ilakya16894@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Swarnalingam |
| Designation |
Professor |
| Affiliation |
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology,Melmaruvathur Adhiparasakthi institute of Medical Sciences and Research,Melmaruvathur,kancheepuram District,Tamilnadu 603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8144008182 |
| Fax |
|
| Email |
lingamjks@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Ilakya |
| Designation |
First year post graduate resident |
| Affiliation |
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research,Melmaruvathur,kancheepuram District,Tamilnadu 603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9176738810 |
| Fax |
|
| Email |
ilakya16894@gmail.com |
|
|
Source of Monetary or Material Support
|
| Melmaruvathur Adhiparasakthi institute of Medical Sciences and Research,Melmaruvathur,kancheepuram District,Tamilnadu,India 603319 |
|
|
Primary Sponsor
|
| Name |
Melmaruvathur Adhiparasakthi institute of Medical Sciences and Research |
| Address |
Melmaruvathur,kancheepuram District,Tamilnadu,India 603319 |
| Type of Sponsor |
Private 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 Ilakya |
Melmaruvathur Adhiparasakthi institute of Medical Sciences and Research |
Department of Aneasthesiology,Operation theatre No. 4 and 5.Post operative recovery room,Operation Theatre Complex,B zone,First floor,Hospital block,kancheepuram,Tamil Nadu
Kancheepuram
TAMIL NADU |
9176738810
ilakya16894@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
butorphanol as additive to intrathecal ropivacaine |
0.1mg of butorphanol (0.5ml) as additive to intrathecal 0.5% isobaric ropivacaine(2.5ml) for patients undergoing lower limb orthopaedic surgeries |
| Comparator Agent |
Cerebrospinal fluid as additive to intrathecal ropivacaine |
Cerebospinal fluid(0.5ml)as additive to intrathecal 0.5% isobaric ropivacaine(2.5ml)by barbotage technique for patients undergoing lower limb orthopaedic surgeries. |
| Intervention |
nalbuphine as additive to intrathecal ropivacaine |
0.5mg of nalbuphine(0.5ml) as additive to intrathecal 0.5% isobaric ropivacaine(2.5ml) for patients undergoing lower limb orthopaedic surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 years
Both gender
American Society of anaesthesiologists(ASA) physical status I and II
Patients undergoing lower limb orthopaedic surgeries under subarachnoid block.
BMI < 30
|
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA 3 and 4
Patients with local infection at the site of injection .
Patients with known or ascertained hypersensitivity to local anaesthetics.
Patient with coagulopathy, bleeding disorders and/or on treatment with anti-coagulants.
Spinal deformities.
- Pregnant women and lactating women
- Other contraindications for spinal anaesthesia
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| postoperative analgesia using VAS pain scale |
postoperative period-2nd 4th 6th 8th 12th 16th 20th and 24th hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Return to bromage score zero |
postoperative period upto 4hours |
| Hemodynamic parameters(Heart rate,Mean arterial pressure,Oxygen saturation) |
baseline,2minutes,4minutes,6minutes,8minutes,10minutes,15minutes,30minutes,45minutes
1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,16hours,20hours,24hours
|
| time to void |
postoperative period upto 24hours |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/06/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL.Will be published after completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - ilakya16894@gmail.com
- For how long will this data be available start date provided 01-06-2021 and end date provided 01-06-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
this study ia a randomised double blinded trail comparing the effectiveness of adding butorphanol and nalbuphine to intrathecal 0.5% isobaric ropivacaine in comparison with plain isobaric 0.5% ropivacaine for lower limb orthopedic surgeries that will be conducted in Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research.Primary outcome will be postoperative analgesic effect using VAS pain Score.Secondary outcomes will be return to Bromage Score 0,hemodynamic parameters(heart rate,mean arterial pressure and oxygen saturation) and time to void. |