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CTRI Number  CTRI/2024/02/062670 [Registered on: 15/02/2024] Trial Registered Prospectively
Last Modified On: 14/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between two drugs with additives in spinal anaesthesia for surgeries below the umbilicus. 
Scientific Title of Study   Comparison between Hyperbaric Bupivacaine with Fentanyl and Hyperbaric Levobupivacaine with Fentanyl in spinal anaesthesia for infraumbilical surgeries- a hospital based 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  Jennifer Konsam 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Anaesthesiology, Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9366532387  
Fax    
Email  jennifer.konsam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr MG Dhorigol 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Anaesthesiology, Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9844778096  
Fax    
Email  mallappadhorigol@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jennifer Konsam 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Anaesthesiology, Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9366532387  
Fax    
Email  jennifer.konsam@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, Belgaum  
 
Primary Sponsor  
Name  Dr Jennifer Konsam 
Address  Dr Prabhakar Kore Hospital Jawaharlal Nehru Medical College Nehru Nagar Belgaum 590010 Karnataka 
Type of Sponsor  Research institution and hospital 
 
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 Jennifer Konsam  JNMC, Belagaum  Department of Anaesthesiology, Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum, Karnataka 590010
Belgaum
KARNATAKA 		 09366532387

jennifer.konsam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hyperbaric Bupivacaine with Fentanyl  Spinal anaesthesia is the most common anaesthesia procedure for patients undergoing surgeries for below the umbilicus level. It is most commonly done using Hyperbaric Bupivacaine as the local anaesthetic agent but Bupivacaine has disadvantages of Cardiovascular system and Central nervous system toxicity. The addition of low dosage of opiods to local anaesthetics in spinal anaesthesia decreases the incidence of local anaesthetic related side effects and increases the quality of intra and post operative analgesia by reducing the amount of local anaesthetic administered. Total sample size of 100 with 50 in each group- B (Bupivacaine) and L (Levobupivacaine). The patients in Group B will be administered 3 ml of Hyperbaric Bupivacaine (0.5%) with 0.5 ml of Fentanyl (25 mcg) using a 23 Guage Quinckes spinal needle at L3-L4 level in sitting position. The plan of the study is to compare the onset and duration of action of sensory and motor blockade and evaluate the hemodynamic changes of the two local anaesthetics, namely Hyperbaric Bupivacaine and Hyperbaric Levobupivacaine in spinal anaesthesia. 
Comparator Agent  Hyperbaric Levobupivacaine with Fentanyl  Levobupivacaine, which is the pure S(-) enantiomer of racemic Bupivacaine has a significantly decreased toxicological profile in comparison to Bupivacaine, especially the Cardiovascular system and the Central Nervous system. Previous data in literature showed not much differences between the two with regard to onset time, duration and spread of sensory and motor blockades as well as to their hemodynamic effects. Isobaric Levobupivacaine has been widely studied in its clinical application in epidural anaesthesia, peripheral nerve blocks, local procedures and spinal anaesthesia but more has to be known about Hyperbaric Levobupivacaines intrathecal administration and its effects. Total sample size of 100 with 50 in each group- B (Bupivacaine) and L (Levobupivacaine). The patients in Group L will be administered 3 ml of Hyperbaric Levobupivacaine (0.5%) with 0.5 ml of Fentanyl (25 mcg) using a 23 Guage Quinckes spinal needle at L3-L4 level in sitting position. The plan of the study is to compare the onset and duration of action of sensory and motor blockade and evaluate the hemodynamic changes of the two local anaesthetics, namely Hyperbaric Bupivacaine and Hyperbaric Levobupivacaine in spinal anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients undergoing infraumbilical surgeries under spinal anaesthesia.
2.ASA grade I and II.
3.Patients willing to give informed consent. 
 
ExclusionCriteria 
Details  1.Hypersensitivity to any of the drugs under study.
2.Non-consenting or unable to give consent.
3.Patients with any contraindication to spinal anaesthesia.
4.Patients who do not fulfill the inclusion criteria. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare the onset and duration of sensory and motor blockade between 0.5% Hyperbaric Bupivacaine with 25mcg Fentanyl and 0.5% Hyperbaric Levobupivacaine with 25mcg Fentanyl for spinal anaesthesia in patients undergoing elective infraumbilical surgeries.  From the time of drug administration till upto 4 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
To study the hemodynamic changes.  From the time of drug administration till upto 4 hours. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/03/2024 
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 anaesthesia is the most commonly used anaesthetic procedure for patients undergoing surgeries for areas below the umbilicus like inguinal hernia, debridement and split skin grafting, hemorrhoidectomy, orthopaedic procedures of the lower limbs, amputations, hysterectomy, etc. It is most commonly performed using 0.5% Hyperbaric Bupivacaine in the present anaesthetic practice but Bupivacaine has disadvantages of Cardiovascular and Central nervous system toxicities.

   Levobupivacaine, which is the pure S(-) enantiomer of racemic Bupivacaine has significantly decreased toxicological profile in comparison to Bupivacaine, especially the Cardiovascular and Central Nervous system toxicities. Previous data in literature showed not much differences between Levobupivacaine and racemic Bupivacaine with regard to onset time, duration and spread of sensory and motor blockades as well as to their hemodynamic effects. Isobaric Levobupivacaine has been widely studied in its clinical application in epidural anaesthesia, peripheral nerve blocks, local procedures and spinal anaesthesia, but more has to be known about Hyperbaric Levobupivacaine’s intrathecal administration and its effects.

   The addition of low doses of Opioids to local anaesthetics during spinal anaesthesia for infraumbilical surgeries decreases the incidence of local anaesthetic related side effects and increases the quality of intra and post-operative analgesia by reducing the amount of local anaesthetic agent administered.

   Opioids like Fentanyl can be combined with local anaesthetics for spinal anaesthesia and it prolongs the duration of action and spread of motor block as well.

   The plan of this study is to compare the onset and duration of action of Hyperbaric Bupivacaine with Fentanyl and Hyperbaric Levobupivacaine with Fentanyl, evaluate the hemodynamic changes. The aim is to compare the efficacy of low dose local anaesthetic agent when used along with opioids to decrease the side effects associated with these local anaesthetics.



 
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