| CTRI Number |
CTRI/2024/09/073674 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of prevalence of phantom limb pain following amputation of lower limb under subarachnoid block versus peripheral nerve blocks |
|
Scientific Title of Study
|
Comparative study of prevalence of phantom limb pain following amputation of lower limb under Subarachnoid block Versus Peripheral nerve blocks-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 JYOTHI PRABHANDA |
| Designation |
MBBS,Post graduation(MD) Anaesthesiology and critical care medicine |
| Affiliation |
SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,SVIMS,ALIPIRI,TIRUPATI,CHITTOOR,ANDHRA PRADESH,517507,INDIA
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
6301550243 |
| Fax |
|
| Email |
prabhanda47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ALOKA SAMANTARAY |
| Designation |
PROFESSOR AND HOD,DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE,SVIMS |
| Affiliation |
SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology,
SVIMS,Alipri,Tirupati,Chittoor,
Andhra Pradesh,517507
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ALOKA SAMANTARAY |
| Designation |
PROFESSOR AND HOD,DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE,SVIMS |
| Affiliation |
SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology,
SVIMS,Alipri,Tirupati,Chittoor,
Andhra Pradesh,517507
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES ALIPIRI ROAD,TIRUPATI,CHITTOOR,ANDHRA PRADESH,517507,INDIA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 PRABHANDA |
SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES(SVIMS) |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE ,SVIMS,ALIPIRI ROAD,TIRUPATI,CHITTOOR,ANDHRA PRADESH,517501,INDIA
Chittoor
ANDHRA PRADESH |
6301550243
prabhanda47@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
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 |
Peripheral Nerve Block |
0.5% Bupivacaine 20 ml+2% Xylocaine 7 ml+Dexmedetomidine 1 microgram/kg+Normal Saline(0.9%) to make a total volume of 30 ml |
| Comparator Agent |
Subarachnoid Block |
Inj.hyperbaric Bupivacaine(0.5%) 3 ml+Dexmedetomidine 5 micrograms given Intrathecally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged above or equal to 18 years who are undergoing lower limb amputation
2.Patients of either gender
3.Patients belonging to Anerican Society of Anesthesiologists Physical status(ASA PS)-I,II,III |
|
| ExclusionCriteria |
| Details |
1.Patients who are not willing to parcipate in the study
2.Preganant and lactating women
3.Patients who have local infection at the site of injection
4.Patients who are allergic to local anesthetics
5.Patients who cannot undersatnd NRS |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the prevalence of phantom limb pain using Numerical Rating Scale(NRS) |
Pain is assesed post operatively using Numerical Rating Scale(NRS) at 6 hours,at 24 hours, 48 hours,72 hours,at the time of discharge,1st month,2nd month and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the severity of phantom limb pain on Numerical Rating Scale
2.To study characteristics of phantom limb pain like-shooting,burning,cramping sensations |
To assess severity of phantom limb pain on Numerical Rating Scale(NRS) at 6 hours,at 24 hours,48 hours,72 hours, at the time of discharge,at 1st month,2nd month & 3rd month |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
24/09/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prabhanda47@gmail.com].
- For how long will this data be available start date provided 01-08-2025 and end date provided 01-08-2030?
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
|
Phantom limb pain is a chronic pain where the pain develops or perceived in a body part that has been amputated.Some studies shows that phantom limb pain occurs within first week of amputation and some studies shows that phantom limb pain occurs within first 3 months. Several anesthestic techniques have been used for the amputation of deceased limb to prevent the incidence of phantom limb pain.Various studies suggest that with central and peripheral nerve blocks there is decrease in the central sensitization which led to the decrease in chronic pain by a reduction in repetitive stimulation of severed nerve roots . This study will be done to compare the subarachnoid block and peripheral nerve blocks for lower limb amputation with an aim to evaluate the prevalence of phantom limb pain. |