| CTRI Number |
CTRI/2025/08/093750 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Study of Intrathecal Hyperbaric Levobupivacaine Alone Versus Combined Hyperbaric and Isobaric Levobupivacaine on Blood Pressure and Nerve Block in Lower Abdominal Surgery. |
|
Scientific Title of Study
|
Effect of Intrathecal Injection of 0.5 PERCENTAGE Hyperbaric Levobupivacaine Versus a Combination of 0.5 PERCENTAGE Hyperbaric and 0.5 PERCENTAGE Isobaric Levobupivacaine on Post-Spinal Hypotension and Block Characteristics in Patients Undergoing Lower Abdominal Surgery- A Double-Blinded 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 |
DR PRIYADHARSHINI S |
| Designation |
Post graduate student |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Departmentofanesthesiology,Pondicherry institute of medical sciences,kalathumettupathai,Ganapathichettikulam,kalapet,Puducherry
Pondicherry Institute of Medical Sciences,Kalathumettupathai,Ganapathichettikulam Village no:20,Kalapet,Puducherry 605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
8754366795 |
| Fax |
|
| Email |
priyasivalingam1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.S.Sivakumar |
| Designation |
Professor and Head Anaesthesiology |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of anesthesiology,Pondicherry institute of medical sciences,kalathumettupathai,Ganapathichettikulam,kalapet,Puducherry
Pondicherry Institute of Medical Sciences,Kalathumettupathai,Ganapathichettikulam Village no:20,Kalapet,Puducherry 605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9944060676 |
| Fax |
|
| Email |
siva85dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRIYADHARSHINI S |
| Designation |
Post graduate student |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of anesthesiology,Pondicherry Institute of Medical Sciences,Kalathumettupathai,Ganapathichettikulam Village no:20,Kalapet,Puducherry 605014
Pondicherry Institute of Medical Sciences,Kalathumettupathai,Ganapathichettikulam Village no:20,Kalapet,Puducherry 605014
Pondicherry
PONDICHERRY
605004
India |
| Phone |
8754366795 |
| Fax |
|
| Email |
priyasivalingam1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of medical sciences,Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014. |
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical Sciences |
| Address |
Pondicherry Institute of Medical Sciences,Kalathumettupathai,Ganapathichettikulam Village No:20,Kalapet,Puducherry 605014 |
| 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 Priyadharshini S |
Pondicherry insinstitute of medical sciences |
Pondicherry institute of medical sciences, kalathumettupathai,Ganapathichettikulam village No:20,kalapet,puducherry 605014
Pondicherry
Pondicherry
PONDICHERRY |
8754366795
priyasivalingam1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.5 percentage hyperbaric and 0.5 percentage isobaric levobupivacaine |
intrathecal injection of 0.5 percentage hyperbaric and 0.5 percentage isobaric levobupivacaine on post spinal hypotension and block characteristics in patients undergoing lower abdomen surgery.Mean Arterial pressure, Heart rate ,oxygen saturation will be monitored every 2 minutes interval for first 20minutes and every 15mins until end of surgery (approximately 3 hours) |
| Comparator Agent |
0.5 percentage hyperbaric levobupivacaine |
intrathecal injection of 0.5 percentage hyperbaric levobupivacaine on post spinal hypotension and block characteristics in patients undergoing lower abdomen surgery.Mean Arterial pressure, Heart rate ,oxygen saturation will be monitored every 2 minutes interval for first 20minutes and every 15mins until end of surgery (approximately 3 hours) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing lower abdominal surgery under spinal anaesthesia of either gender
2.Age 18 – 70 years
3.American Society of Anesthesiologists classification I – II
|
|
| ExclusionCriteria |
| Details |
1.contraindications for neuraxial anesthesia include local sepsis, coagulopathy, increased intracranial pressure, and spinal deformity
2.Patients having Heart rate <50bpm
3.Patients allergic to study drugs
4.Severe valvular stenotic lesion sepsis, 5.Patients with preexisting Neurological or neuromuscular diseases,Pregnant women |
|
|
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 |
Primary objective:
To compare the incidence of post-spinal hypotension in patients receiving intrathecal 0.5 %
hyperbaric levobupivacaine versus the combination of intrathecal 0.5% hyperbaric and 0.5%
isobaric levobupivacaine in patients undergoing lower abdominal surgery under spinal
anesthesia. |
Hypotension measured in every 2 mins for 20 mins and every 15 mins till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess other hemodynamic parameters (HR, SBP, DBP, MAP) between both groups
at different time intervals
2. To calculate the dose of vasopressors required in each group
8
3. To assess block characteristics.
4. Time to 1
st analgesic requirement postoperatively in both groups
5. To note complications in both groups |
The sensory level will be assessed every 15 mins until 2 segment regression is achieved.Time to motor function recovery is also assessed . |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/09/2025 |
| 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="2"
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
|
Effect of intrathecal Injection of 0.5 % hyperbaric levobupivacaine versus a combination of 0.5% hyperbaric and 0.5% isobaric levobupivacaine on post spinal hypotension and block characteristics in lower abdomen surgery – A Double blinded Randomized Control Trial |