| CTRI Number |
CTRI/2024/10/075154 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare heamodynamic stability of Bolus versus fractionated injection of hyperbaric bupivacaine in spinal anaesthesia among patients undergoing femur fracture surgery |
|
Scientific Title of Study
|
Efficacy of Bolus versus fractionated injection of hyperbaric bupivacaine in spinal anaesthesia among patients undergoing femur fracture surgery: A randomized control trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritesh Bhola |
| Designation |
Junior resident |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD |
| Address |
DEPARTMENT OF ANESTHESIA MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9999836316 |
| Fax |
|
| Email |
bholaritesh@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V M Sasturkar |
| Designation |
Professor |
| Affiliation |
MGM Medical College and Hospital Aurangabad |
| Address |
Department of Anaesthesia MGM Medical College and Hospital N6 CIDCO Aurangabad
Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9370668196 |
| Fax |
|
| Email |
vasantikelkar70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V M Sasturkar |
| Designation |
Professor |
| Affiliation |
MGM Medical College and Hospital Aurangabad |
| Address |
Department of Anaesthesia MGM Medical College and Hospital N6 CIDCO Aurangabad
Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9370668196 |
| Fax |
|
| Email |
vasantikelkar70@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital N6 CIDCO Aurangabad 431005 MAHARASHTRA INDIA |
|
|
Primary Sponsor
|
| Name |
MGM Medical College and Hospital Aurangabad |
| Address |
Department of Anaesthesia MGM Medical College and Hospital N6 CIDCO Aurangabad |
| 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 RITESH BHOLA |
MGM HOSPITAL AURANGABAD |
OT NO. 6 AND 7 ( ORTHOPEDIC OT) OT COMPLEX
Aurangabad
MAHARASHTRA |
9999836316
bholaritesh@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Ethics Committee For Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (3) ICD-10 Condition: W19||Unspecified fall, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bolus injection of hyperbaric bupivacaine in spinal anaesthesia among patients undergoing femur fracture surgery |
25 patients will be given spinal anaesthesia for the femur fracture surgery. for that they will receive single Intra thecal bolus dose of 0.5% Hyperbaric bupivacaine + 45 micrograms of Bupinorphine ( total 3.1ml) |
| Intervention |
fractionated injection of hyperbaric bupivacaine in spinal anaesthesia among patients undergoing femur fracture surgery |
25 patients will be given spinal anaesthesia for the femur fracture surgery. For that they will receive Intra thecal fractionated dose of 0.5% Hyperbaric bupivacaine + 45 micrograms of Bupinorphine ( total 3.1ml ).First 2ml of dose will be given as bolus and after waiting for 90 seconds remaining 1.1 ml of dose will be given. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Elective Femur fracture surgeries under Spinal Anaesthesia.
2. Patients between age 60-80 years
3. ASA grade I, II and III.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with suspected inability to comply with the study procedure.
2. Known allergy to drug study.
3. History of liver Renal and Cardiac disease. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE HEAMODYNAMIC PARAMETERS (HEART RATE AND MEAN ARTERIAL BLOOD PRESSURE) BETWEEN THE TWO STUDY GROUPS. |
Intra Op Monitoring of Heart Rate Blood pressure and Mean arterial Pressure every 3 minutes for first 20 minutes. Thereafter every 10 minutes till regression of sensory block to L1 level |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intra Op Monitoring of motor & sensory characteristics |
Level of sensory block was checked every 3 minutes till peak sensory level that is two consecutive reading at the same dermatomal level will be achived. Thereafter sensory block will be tested every 20 min till the block regression to L1 level.Motor blockade will be checked every 3 minutes for first 20 minutesfrom start of surgery & every 10 minutes thereafter. |
|
|
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)
|
15/11/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Spinal anaesthesia (SA) is routinely used to provide anaesthesia for femur fracture surgeries. Here the entire dose of the local anesthetic is administered all at once as a bolus injection . It has quick onset making it suitable for procedures requiring fast and complete anaesthesia. Bolus injection is straightforward to administer and requires minimal manipulation of syringe. In recent literature, studies have been conducted especially in Caesarean section patients in which local anaesthetic is injected in fractionated manner for Spinal anaesthesia. In this method two thirds of the total calculated dose of local anaesthetic is initially injected ; and one- third dose after a time-gap of 90 seconds (1). These studies have observed dense spinal blockade with lower maximum sensory level in these patients. In Spinal anaesthesia there is sensory motor as well as sympathetic blockade. Level of sympathetic blockade is higher than sensory blockade(2). If there is higher sympathetic blockade it leads to severe hypotension. In older population which routinely come for femur fracture surgeries, this hypotension is deleterious considering associated co morbidities. We will be conducting a prospective study to compare Efficacy of Bolus versus fractionated injection of hyperbaric bupivacaine in spinal anaesthesia among patients undergoing femur fracture surgeries. Primary outcome of our study will be comparison of hemodynamic parameters. Secondary outcome will be comparison of spinal block characteristics. We hypothesize that giving local anaesthetic in fractionated manner is better method |