| CTRI Number |
CTRI/2024/06/068959 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Levobupivacaine and fentanyl when given in fractionated dose versus when given sequentially for spinal anaesthesia |
|
Scientific Title of Study
|
Intrathecal fentanyl with hyperbaric levobupivacaine 0.5% in fractionated versus sequential dose spinal anaesthesia: Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeharika Arora |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room No 2062-D, Department of Anaesthesia, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8077104070 |
| Fax |
|
| Email |
docneehars@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeharika Arora |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room No 2062-D, Department of Anaesthesia, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8077104070 |
| Fax |
|
| Email |
docneehars@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajat Kumar Agrawal |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room No 2062-D, Department of Anaesthesia, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9098682222 |
| Fax |
|
| Email |
rajatagrawal143@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh, India
Pin 243006 |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital |
| Address |
Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly |
| 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 Neeharika Arora |
Rohilkhand Medical College and Hospital |
Operation theater, Department of Anaesthesia, RMCH, Philibhit bypass road
Bareilly
UTTAR PRADESH |
8077104070
docneehars@gmail.coM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, RMCH, Bareilly, U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractionated dose spinal anaesthesia |
Patients will be administered a fractionated dose of of 3ml - with 2/3rd I.e. 2ml of the total dose given initially, the syringe kept attached to the spinal needle for 45s after which remaining 1/3rd dose will be administered |
| Comparator Agent |
Sequential dose spinal anaesthesia |
patients will be administered a sequential dose - 2.5 mL hyperbaric Levobupivacaine 0.5% followed by 25 mcg fentanyl, through a separate syringe, with less than 5 seconds between the change of syringes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of Anaesthesiologist (ASA) grade I or II
2. Patient undergoing elective infra umbilical surgeries |
|
| ExclusionCriteria |
| Details |
1. Patient refusal for the procedure
2. Infection at the site
3. Any abnormality of spine
4. Allergy to local anaesthetics
5. Coagulopathy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Onset of sensory & motor blockade
2. Highest level of sensory block
3. Time for two segment regression of sensory block
4. Duration of motor blockade
5. Time for first rescue analgesic
6. Incidence of post-operative nausea, vomiting and post spinal shivering.
|
Sensory block will be assessed after 1 minute of injection every 1min until the level is established for four consecutive tests, after that assessment will continue every 10 min until 2 segment regression occurs. The time for motor block from bromage 3 to bromage 2 will be considered as the duration of motor blockade.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters (Heart rate, systolic and diastolic blood pressure, mean arterial pressure) |
During the surgery the patient’s heart rate, Systolic and Diastolic blood pressure, Mean Arterial Pressure, arterial oxygen saturation will be recorded every 5 mins for 30 minutes and then every 10 minutes until completion of the surgery. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/07/2024 |
| 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 - NO
|
|
Brief Summary
|
Spinal anesthesia has significantly evolved, offering various techniques and adjuvants to enhance efficacy and patient outcomes. Notably, the combination of intrathecal fentanyl with hyperbaric levobupivacaine is of great interest. This study compares the efficacy of this combination when administered through Sequential Spinal Anesthesia (SSA) and Fractionated Spinal Anesthesia (FSA).
Hyperbaric levobupivacaine, a long-acting local anesthetic with reduced cardiovascular toxicity, is favored in spinal anesthesia. When combined with fentanyl, known for its rapid onset and analgesic properties, it potentially enhances spinal anesthesia quality by providing optimal intraoperative conditions and extended postoperative analgesia.
FSA, an innovative technique to mitigate hypotension, administers the local anesthetic in fractions with short intervals, aiming for a more controlled block with fewer hemodynamic issues. However, concerns about complications like post-dural puncture headache and neurological deficits limit its use.
In contrast, SSA involves sequential administration of anesthesia components, each tailored to exploit specific benefits, offering an alternative to FSA’s challenges. The baricity of the fentanyl and hyperbaric levobupivacaine mixture can affect local anesthetic spread in cerebrospinal fluid (CSF), impacting anesthesia efficacy.
Research indicates that mixing adjuvants with hyperbaric bupivacaine can alter CSF distribution, whereas administering them separately might avoid these changes, improving onset, duration, and hemodynamic stability.
The study evaluates FSA versus SSA by examining sensory and motor blockade onset and duration, intraoperative conditions, and hemodynamic stability. This research aims to fill gaps in existing literature and enhance spinal anesthesia practices, aiding practitioners in providing better patient care.
This study seeks to critically examine and compare the efficacy of intrathecal fentanyl with hyperbaric levobupivacaine 0.5% when administered through two different dosing strategies fractionated spinal anaesthesia and sequential spinal anaesthesia. Key parameters under scrutiny include the onset and duration of sensory and motor blockade, intraoperative conditions, and hemodynamic stability. This research endeavours to contribute nuanced insights into refining spinal anesthesia administration techniques, ultimately aiming for enhanced patient safety, comfort, and positive perioperative experiences.
By shedding light on the comparative merits of Sequential and Fractionated Spinal Anesthesia, this investigation aspires to guide anaesthetic practitioners in making informed decisions, advancing the standards of spinal anesthesia practice for improved patient care.
|