| CTRI Number |
CTRI/2024/11/076978 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study Comparing Two Methods of Giving Spinal Anesthesia: One Full Dose vs fractioned Dose of 0.5% Heavy Bupivacaine for hip surgery in elderly patient |
|
Scientific Title of Study
|
A randomised controlled trial to compare fractionated dose versus conventional bolus dose method of drug administration in spinal anaesthesia for surgical repair of hip fracture in the elderly patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshay Kumar |
| Designation |
Junior Resident |
| Affiliation |
Dr. Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh |
| Address |
Room Number 101 Operation Theatre complex 3rd Floor Department of Anaesthesia
Dr. Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8894604703 |
| Fax |
|
| Email |
alphaakshay24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Versha Verma |
| Designation |
Associate Professor |
| Affiliation |
Dr. Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh |
| Address |
Room Number 104 Operation Theatre complex 2nd Floor Department of Anaesthesia
Dr. RPGMC TANDA
KANGRA
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418152286 |
| Fax |
|
| Email |
versha2u@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Akshay Kumar |
| Designation |
Junior Resident |
| Affiliation |
Dr. Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh |
| Address |
Room Number 101 Operation Theatre complex 3rd Floor Department of Anaesthesia
Dr. Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8894604703 |
| Fax |
|
| Email |
alphaakshay24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Superintendant Office Room No. 203 First Floor(Block A) Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Akshay Kumar |
| Address |
Village Sadarpur Tanda Kangra Himachal Pradesh |
| 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 Akshay Kumar |
Dr. Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh |
Operation Theatre complex 3rd Floor Department of Anaesthesia Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH |
8894604703
alphaakshay24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee Dr. Rajendra Prasad Government Medical College Tanda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fractionated spinal anaesthesia versus conventional bolus dose of spinal anaesthesia |
Comparison of fractional dose versus conventional bolus dose of 0.5% bupivacaine in spinal anaesthesia for hip surgery in elederly patients to assess the hemodynamic changes following fractional and bolus dose of spinal anaesthesia during spinal component of CSEA one group receiving 2.5ml of 0.5% hyperbaric bupivacaine in Subarachnoid space in conventional manner over 10 seconds before start of surgery while other group will recieve the 0.5% hyperbaric bupivacaine drug in fractions 1.7ml initially and 0.8 ml after 90 seconds before start of surgery Total duration of this study will be 12 months |
| Intervention |
Fractionated spinal anaesthesia versus conventional bolus dose of spinal anaesthesia |
Patients are randomly selected Combined Spinal Epidural anaesthesia technique will be followed in both groups with one group receiving 2.5ml of 0.5% hyperbaric bupivacaine in Subarachnoid space in conventional manner over 10 seconds before start of surgery while other group will recieve the 0.5% hyperbaric bupivacaine drug in fractions 1.7ml initially and 0.8 ml after 90 seconds before start of surgery
Total duration of this study will be 12 months |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with American Society of Anaesthesiologists(ASA) physical status more than 2
BMI 18.5- 29.9 |
|
| ExclusionCriteria |
| Details |
Patients refusal to participate in the study
Patients with anatomical spinal deformities
Patients with bleeding disorders and raised intracranial pressure
Hypersensitivity to local anaesthetic and study drugs
Local infection at site where needle for spinal is to be inserted
Patients with dysthymia
Patients on anticoagulant
Failure of spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess hemodynamic changes following fractional and conventional bolus dose of 0.5% bupivacaine in spinal anaesthesia during spinal component of combined spinal epidural anaesthesia |
At start of surgery, 3 minutes after start of surgery, 5 minutes after start of surgery then every 5 mins till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Onset time of sensory(T10) level
2.Time taken for complete motor block
3.Two segment regression of sensory block
4.Duration of analgesia
5.Time of administration of first epidural bolus for anaesthesia
6.Total number of patients and doses of epidural bolus required in intraoperative period and in 24 hours
7.Any incidence of adverse effect |
At start of surgery, 3 minutes after start of surgery, 5 minutes after start of surgery then every 5 mins till end of surgery |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- 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 who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [alphaakshay24@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a prospective, randomised double blind study to assess the hemodynamic changes following fractional And conventional bolus dose of 0.5% hyperbaric bupivacaine in spinal anaesthesia during spinal component of Combined Spinal Epidural anaesthesia in elderly patients undergoing hip surgery |