| CTRI Number |
CTRI/2024/05/067761 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
fractional versus normal spinal anesthesia in old aged patients posted for orthopedic surgery:A Prospective Randomised double blinded study |
|
Scientific Title of Study
|
comparison of fractional versus conventional spinal anesthesia in geriatric patients posted for orthopedic surgery : A Prospective Randomised, double blinded 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 Archana Endigeri |
| Designation |
Associate professor,Department of Anaesthesiology |
| Affiliation |
SNMC and HSK hospital Bagalkote |
| Address |
3rd Floor
Department of Anaesthiology
S.NIJALINGAPPA MEDICAL COLLEGE AND HANAGAL SHRI KUMARESHWAR HOSPITAL AND RESEARCH CENTRE
BAGALKOTE KARNATAKA
Bagalkot
KARNATAKA
587102
India |
| Phone |
7406568382 |
| Fax |
|
| Email |
archanaendigeri86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Archana Endigeri |
| Designation |
Associate professor,Department of Anaesthesiolo |
| Affiliation |
SNMC and HSK hospital Bagalkote |
| Address |
3rd floor
Department of Anaesthesiology
S.NIJALINGAPPA MEDICAL COLLEGE AND HANAGAL SHRI KUMARESHWAR HOSPITAL AND RESEARCH CENTRE
BAGALKOTE KARNATAKA
Bagalkot
KARNATAKA
587102
India |
| Phone |
7406568382 |
| Fax |
|
| Email |
archanaendigeri86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pragna H |
| Designation |
1st Year PG student |
| Affiliation |
SNMC and HSK hospital Bagalkote |
| Address |
3rd floor
Department of Anaesthesiology S.NIJALINGAPPA MEDICAL COLLEGE AND HANAGAL SHRI KUMARESHWAR HOSPITAL AND RESEARCH CENTRE
BAGALKOTE KARNATAKA
Bagalkot
KARNATAKA
587102
India |
| Phone |
7022102997 |
| Fax |
|
| Email |
pragnahospet@gmail.com |
|
|
Source of Monetary or Material Support
|
| 2nd floor
S Nijalingappa Medical College and HSK Hospital , Navnagar Bagalkote |
| S. Nijalingappa medical college and HSK hospital Bagalkot |
|
|
Primary Sponsor
|
| Name |
S Nijalingappa medical college and HSK hospital |
| Address |
1st floor , Major OT Complex, S.Nijalingappa Medical College and HSK Hospital |
| 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 Archana Endigeri |
S Nijalingappa Medical College and HSK hospital |
Orthopedics OT
Ground Floor, HSK Hospital S.N.M.C Navanagar Bagalkote
Bagalkot
KARNATAKA |
7406568382
archanaendigeri86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, (2) ICD-10 Condition: T882||Shock due to anesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Geriatric orthopedic patients |
Patients will be randomly assigned into two groups using computer generated randomised table and NIBP,ECG,pulse oxymeter will be connected and parameters will be recorded.Spinal anesthesia given with 25G quinckes spinal needle and drug volume of 3ml 0.5% hyperbaric bupivacaine will be administered. Group c will recieve bolus dose of of 15mg bupivacaine 0.5% at a rate of 0.2ml/sec. Duration of study is 2-3 hrs |
| Intervention |
Geriatric orthopedic patients |
Patients will be randomly assigned into two groups using computer generated randomised table and NIBP,ECG,pulse oxymeter will be connected and parameters will be recorded.Spinal anesthesia given with 25G quinckes spinal needle and drug volume of 3ml 0.5% hyperbaric bupivacaine will be administered. Group F will recieve half dose of the total volume, after 60s other half will be injected. Duration of intervention is 2-3hrs |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
A total of patients aged 60yrs old who were candidates for lower limb
fracture surgery with ASA I , II & III will be included
2. Patients willing for being a part of the study with written informed
consent. (Annexure 1A, 1B, 1C) |
|
| ExclusionCriteria |
| Details |
. Patients who are not willing to give written informed consent.
2. Patients below 60 years of age.
3. Patients with ASA greater than III
4. The patients with absolute contraindications of spinal
anesthesia, such as patient’s refusal , localised infection at the
injection site, allergy to anesthetic drugs, patient’s inability to
maintain position during the procedure, increased ICP
5. Relative spinal contraindications such as myelopathy or
peripheral neuropathy, spinal stenosis, history of spinal
surgery, multiple sclerosis, spina bifida, aortic stenosis,
hypovolemia, hereditary coagulopathies, |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the incidence of hypotension among the conventional and fractional spinal anaesthesia group |
3hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Haemodynamic parameters
2.onset of sensory & motor blockade
3.Duration of sensory & motor blockade
4.Requirments of vasopressor
5.Time for 1st rescue analgesia
6.complications in both the groups |
24hrs |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| 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="3"
Months="0"
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) frequently performed for lower limb orthopedic surgeries has rapid onset but at the same time, it precipitates hypotension. : Incidence of hypotension during spinal anesthesia for lower limb surgeries in elderly is as high as 92-94% if no preventive measures are taken The rapid onset of spinal anaesthesia can lead to complications such as hypotension, which can be dangerous to the patient, Therefore, recently a fractionated dose injection technique has been developed known as Fractionated Spinal Anesthesia (FSA) in which a local anesthetic agent is given in fractions with a time gap of 60sec-90 sec. This helps in reducing the incidence of hypotension by providing dense blockage with hemodynamic stability and prolonged duration of effective analgesia.Spinal anaesthesia with fractionated method could lead to lower hypotension and bradycardia, longer sensory blockage duration, a more favourable anaesthesia level with lesser complications , in comparision with the bolus method. So, we decided to compare bolus dose conventional spinal versus fractionated dose of bupivacaine in spinal anesthesia for lower limb surgeries in elderly with regard to its effects on incidence of hypotension as our primary objective and Hemodynamic parameters(BP&HR) , block characteristics like Onsent of Sensory and Motor blockade,Duration of sensory and motor blockade Requirments of Vasopressors Time for 1st rescue analgesia Complications in both the groups as well as duration of post-operative analgesia as our secondary objectives. |