| CTRI Number |
CTRI/2025/07/090371 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Methods of Giving Spinal Anesthesia (Fractional vs. Single Dose) in Patients Undergoing Lower Abdominal or Leg Surgery: A Study on Safety and Effectiveness |
|
Scientific Title of Study
|
Comparative Study on the Effect of Fractional versus Bolus Dose of Levobupivacaine Used in Spinal Anesthesia in Patients Undergoing Lower Abdominal and Lower Limb Orthopedic Surgery: A Prospective Randomized Controlled 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 |
Kashish Garg |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER Satellite Centre Sangrur |
| Address |
Department of anaesthesia and intensive care
Sangrur PUNJAB 148001 India |
| Phone |
09501188562 |
| Fax |
|
| Email |
kashishg83@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Kashish Garg |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER Satellite Centre Sangrur |
| Address |
Department of anaesthesia and intensive care
Sangrur PUNJAB 148001 India |
| Phone |
09501188562 |
| Fax |
|
| Email |
kashishg83@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kashish Garg |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER Satellite Centre Sangrur |
| Address |
Department of anaesthesia and intensive care
Sangrur PUNJAB 148001 India |
| Phone |
09501188562 |
| Fax |
|
| Email |
kashishg83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate Institute of Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Dr Kashish Garg |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER Satellite Centre Sangrur |
| 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 Kashish Garg |
PGIMER Satellite Centre Sangrur Punjab |
Department of anaesthesia and intensive care
PGIMER Satellite Centre Sangrur Punjab 148001
Chandigarh
india Sangrur PUNJAB |
09501188562
kashishg83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research Chandigarh |
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 |
conventional spinal anaesthesia technique |
o A dose of 15 mg levobupivacaine (0.5%) will be injected intrathecally in a single bolus dose manner.
o Patients will be positioned supine immediately after administration
|
| Intervention |
Fractional Spinal Anaesthesia technique |
o The 15 mg dose is divided into two equal portions.
o The second half dose is administered after a 45-second interval while maintaining needle placement.
o Patient will be positioned supine immediately after administration
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
o ASA physical status I or II.
undergoing elective lower abdominal or lower limb orthopedic surgeries. |
|
| ExclusionCriteria |
|
|
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 |
1. Fall in mean blood pressure
2. Total number of doses of vasopressor required |
Recorded at baseline and immediately after administering Spinal Anaesthesia, followed by every 2 minutes for the first 10 minutes of administering Spinal Anaesthesia, followed by every 3 min till the next 30 min, followed by every 5 minutes until surgery gets over
• Assessment will be done every 30 minutes in the postoperative period till sensory and motor variables returns back to normal
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Onset & duration of sensory & motor blockade.
2.Highest sensory block level achieved.
3.Post-operative pain & time to first rescue analgesia.
4.Incidence of adverse events (e.g., nausea, vomiting, shivering, respiratory distress).
|
Recorded at baseline & immediately after administering Spinal Anaesthesia, followed by every 2 minutes for the first 10 minutes of administering Spinal Anaesthesia, followed by every 3 min till the next 30 min, followed by every 5 minutes until surgery gets over
• Assessment will be done every 30 minutes in the postoperative period till sensory & motor variables returns back to normal
|
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
01/08/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a commonly used technique for lower abdominal and limb surgeries due to its rapid onset and cost-effectiveness. However, it often causes hemodynamic disturbances like hypotension and bradycardia. To mitigate these effects, fractional spinal anesthesia—administering the anesthetic in divided doses—has emerged as a promising technique, allowing gradual onset of sympathetic blockade and greater hemodynamic stability. Levobupivacaine, the S(-) enantiomer of bupivacaine, is favored for spinal anesthesia due to its reduced cardiotoxicity and better hemodynamic profile. Despite extensive use, most studies evaluating levobupivacaine have focused on bolus dosing, leaving the potential benefits of fractional dosing underexplored. This prospective randomized controlled trial aims to compare the effects of fractional versus bolus dosing of intrathecal levobupivacaine in patients undergoing lower abdominal and orthopedic limb surgeries. The primary focus is on hemodynamic stability—specifically, the incidence of significant blood pressure drops and vasopressor requirements. Secondary outcomes include onset and duration of sensory/motor blockade, highest block level, postoperative pain, and adverse events. By investigating a safer, more stable approach to spinal anesthesia, especially for patients with cardiovascular risk, this study seeks to optimize anesthetic techniques for improved patient outcomes and reduced intraoperative complications. |