| CTRI Number |
CTRI/2025/03/082060 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effects of Single vs. Multiple Doses of Spinal Anesthesia for Lower Limb Surgery |
|
Scientific Title of Study
|
Comparison of bolus dose versus fractionated dose of hyperbaric bupivacaine
and fentanyl in spinal anaesthesia among adult patients undergoing lower limb surgery |
| 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 Narjeet Kaur Osahan |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Department Of Anaesthesia, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab
Ludhiana
PUNJAB
141008
India |
| Phone |
9815200805 |
| Fax |
|
| Email |
drnarjeet10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manavdeep Singh |
| Designation |
PG Resident |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Department Of Anaesthesia, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab
Ludhiana
PUNJAB
141008
India |
| Phone |
9915381178 |
| Fax |
|
| Email |
manav1196@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manavdeep Singh |
| Designation |
PG Resident |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Department Of Anaesthesia, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab
PUNJAB
141008
India |
| Phone |
9915381178 |
| Fax |
|
| Email |
manav1196@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab, 141008 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College and Hospital |
| Address |
Department Of Anaesthesia, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab, 141008 |
| 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 Narjeet Kaur Osahan |
Christian Medical College and Hospital |
Department Of Anaesthesia, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab
Ludhiana
PUNJAB |
09815200805
drnarjeet10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Christian Medical College |
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 |
| Comparator Agent |
Hyperbaric Bupivacaine (0.5%) + Fentanyl (25 mcg) – Bolus Dose |
Dose: 2.5 ml (12.5 mg) of Bupivacaine + 0.5 ml (25 mcg) of Fentanyl
Frequency: Single administration
Route of Administration: Intrathecal (spinal anesthesia)
Duration of Therapy: Given as a single bolus injection intrathecally. |
| Intervention |
Hyperbaric Bupivacaine (0.5%) + Fentanyl (25 mcg) – Fractionated Dose |
Dose: 2.5 ml (12.5 mg) of Bupivacaine + 0.5 ml (25 mcg) of Fentanyl
Frequency; Single administration
Route of Administration: Intrathecal (spinal anesthesia)
Duration of Therapy: Given as a fractionated dose,2 ml of the total dose injected initially, followed by the remaining 1 ml after 90 seconds.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who give informed consent.
2. ASA (American Society of Anaesthesiologists) I & II[ANNEXURE1]
3. All men and women
4. Adult 18-60 years
5. Elective lower limb surgeries under spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Patients with significant neurological deficit.
2. Spinal column deformities.
3. Patients on anticoagulants.
4. Allergic to local anaesthetic.
5. Allergic to adjuvant drug.
6. Patient with any skin lesion at the injection site.
|
|
|
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 |
1. To compare the effects on haemodyamic parameters on patient receiving Bolus dose vs Fractionated dose of intrathecal bupivacaine and fentanyl.
|
Hemodynamic Trends (HR, SBP, DBP, MAP, SpO2)-Baseline (before spinal anesthesia), then intraoperatively at 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min, 30 min, 40 min, 50 min, 60 min, 70 min, 80 min, 90 min, 100 min, 110 min, and 120 min.
Postoperatively at 30 min, 1 hour, 1.5 hours, 2 hours, then hourly up to 6 hours.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare block characteristics & post operative analgesia in patients receiving Bolus dose vs Fractionated dose of intrathecal bupivacaine & fentanyl. |
Sensory & Motor Block Characteristics-Every 5 minutes intraoperatively until maximum block is achieved, then postoperatively at 30 min, 1 hour, 1.5 hours, 2 hours, then hourly up to 6 hours.
Duration of Postoperative Analgesia- Postoperatively at 30 min, 1 hour, 1.5 hours, 2 hours, then hourly up to 6 hours. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
22/03/2025 |
| 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 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 - NO
|
|
Brief Summary
|
Spinal
anesthesia plays a critical role in lower limb surgeries, offering effective
analgesia and muscle relaxation. The choice between fractionated dose and bolus
dose administration of bupivacaine remains a topic of debate among
anesthesiologists, with implications for patient outcomes and surgical success.
This thesis aims to provide a comprehensive comparative analysis of
fractionated dose versus bolus dose administration of bupivacaine in spinal
anesthesia for lower limb surgery, focusing on efficacy, safety, and
patient-centered outcomes.
Aims and
Objectives:
1. To compare
the effects on haemodynamic parameters between Bolus dose versus Fractionated
dose of intrathecal bupivacaine and fentanyl.
2. To compare
the block characteristics and post operative analgesia in patients receiving Bolus
dose vs Fractionated dose of intrathecal bupivacaine and fentanyl.
Materials and
Methods:
This will be a randomized double blind study to be
done on 90 patients of 18-60 years of age admitted at Christian Medical College
and Hospital Ludhiana scheduled for elective lower limb surgery under spinal
anaesthesia. They will be divided into two groups using block randomisation
method (Group A-Bolus dose and Group B- Fractionated dose). The parameters like
sensory blockade, motor blockade and hemodynamic profile along with duration of
analgesia will be evaluated. |