CTRI

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CTRI Number

CTRI/2024/04/066156 [Registered on: 23/04/2024] Trial Registered Prospectively

Last Modified On:

22/04/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

To compare the efficacy between Intrathecal Isobaric Levobupivacaine With Fentanyl And hyperbaric Levobupivacaine With Fentanyl in terms of block charecterstics, duration of pain relief in patients undergoing femoral nail surgeries for Lower limbs

Scientific Title of Study

A Comparison of The Intrathecal Isobaric Levobupivacaine With Fentanyl And Hyperbaric Levobupivacaine With Fentanyl For Proximal Femoral Nailing Surgeries: A Prospective Randomised Double Blind Controlled 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 Meda Venkata Srinivas
Designation	Assistant professor
Affiliation	Government Medical College,Cuddapah
Address	Room no 200 Department of anesthesiology Government medical college, Cuddapah. Andhra Pradesh Assistant professor, Department of anesthesia Government Medical College, Cuddapah Cuddapah ANDHRA PRADESH 516002 India
Phone	9866301497
Fax
Email	srinivasmedadoc@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Meda Venkata Srinivas
Designation	Assistant professor
Affiliation	Government Medical College,Kadapa
Address	Department of Anesthesia Government Medical College Cuddapah Cuddapah ANDHRA PRADESH 516002 India
Phone	9866301497
Fax
Email	srinivasmedadoc@gmail.com

Details of Contact Person
Public Query

Name	Dr Meda Venkata Srinivas
Designation	Assistant professor
Affiliation	Government Medical College, Kadapa
Address	Department of Anesthesia Government Medical College, Kadapa Cuddapah ANDHRA PRADESH 516002 India
Phone	9866301497
Fax
Email	srinivasmedadoc@gmail.com

Source of Monetary or Material Support

Department of Anesthesiology, Government Medical College, Cuddapah Andhra Pradesh India

Primary Sponsor

Name	Dr Sunil Chiruvella
Address	Department of Anesthesiology Government Medical College, Kadapa
Type of Sponsor	Other [self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Meda Venkata Srinivas	Government General Hospital.	Room no 200 Department of anesthesiology Puttlampalli Cuddapah Cuddapah ANDHRA PRADESH	9866301497 srinivasmedadoc@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committe,Government Medical College,Kadapa,	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M00-M99\|\|Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	0,5% Hyperbaric Levobupivacaine	A comparison of the intrathecal Isobaric Levobupivacaine with fentanyl and Hyperbaric Levobupivacaine with fentanyl for proximal femoral nailing surgeries,-A prospective randomised double blind controlled study
Intervention	Isobaric Levobupivacaine with Fentanyl	Hyperbaric Levobupivacaine with Fentanyl

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patients of ASA PS I and ASA PS II

ExclusionCriteria

Details

Patient refusal
Allergic to local anesthetics
Pregnancy
Absolute contraindications to Regional anesthesia

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
To compare the sensorial, motor block levels ,and side effects	Baseline After spinal anesthesia 3min 6min 9min 12min 15min 20 min 25min 30min 35min 40min 45min At the end of surgery

Secondary Outcome

Outcome	TimePoints
To compare hemodynamic changes, intraoperative analgesia requirement and time for first rescue analgesic requirement in postoperative period.	Baseline After spinal anesthesia 3min 6min 9min 12min 15min 20min 25min 30min 35min 40min 45min At the end of surgery.

Target Sample Size

Total Sample Size="72"
Sample Size from India="72"
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)

07/05/2024

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="0"
Months="3"
Days="5"

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

In this prospective randomized controlled study , block characterstics ,side effects and hemodynamic effects will be studied between isobaric levobupivacaine and hyperbaric levobupivacaine injected intrathecally. Subarachnoid block is the most commonly used regional anesthesia technique in contemporary anesthesia practice. Motor block from subarachnoid anesthesia beyond the duration of surgery is undesirable, particularly in ambulatory setting,and this is the most important reason why subarachnoid block is not preferred in ambulatory setting.With introduction of levobupivacaine as pure S(-) enantiomer of bupivacaine which offers advantages of lower cardiotoxicity and neurotoxicity and shorter motor block duration,its use has widely increased in india.