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CTRI Number  CTRI/2024/10/075645 [Registered on: 22/10/2024] Trial Registered Prospectively
Last Modified On: 19/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Randomized control study]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study of effectiveness of two different drugs (ropivacaine and levobupivacaine) in patients undergoing spinal anaesthesia for radiation therapy in gynecological cancers. 
Scientific Title of Study   Comparative study of effectiveness of intrathecal hyperbaric ropivacaine and hyperbaric levobupivacaine in combination with fentanyl in patients undergoing brachytherapy for gynecological malignancy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DAPHY ANDREA A 
Designation  POST GRADUATE 
Affiliation  St. Johns Medical College and Hospital 
Address  Department of Anaesthesiology,Second Floor OT Complex, St. Johns Medical College and Hospital, Bangalore-560034 Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bangaore

Bangalore
KARNATAKA
560034
India 
Phone  9865922802  
Fax    
Email  ag.daf16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SURBHI GUPTA 
Designation  PROFESSOR 
Affiliation  St.Johns Medical College and Hospital 
Address  Department of Anaesthesiology,Second Floor OT Complex, St. Johns Medical College and Hospital, Bangalore-560034 Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bangaore

Bangalore
KARNATAKA
560034
India 
Phone  9880109361  
Fax    
Email  surbhi_pg@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DAPHY ANDREA A 
Designation  POST GRADUATE 
Affiliation  St.Johns Medical College and Hospital 
Address  Department of Anaesthesiology,Second Floor OT Complex, St. Johns Medical College and Hospital, Bangalore-560034 Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bangaore

Bangalore
KARNATAKA
560034
India 
Phone  9865922802  
Fax    
Email  ag.daf16@gmail.com  
 
Source of Monetary or Material Support  
St Johns medical college and hospital, Koramangala, Bangalore-560034 
 
Primary Sponsor  
Name  Dr Daphy Andrea Department of Anaesthesiology 
Address  Department of Anaesthesiology ,Second Floor OT Complex,St. Johns Medical College and Hospital, Bangalore-560034 
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 
Daphy Andrea  St Johns medical college and hospital  Department Of Anaesthesiology, Second floor OT Complex, St Johns medical college and hospital.Koramangala, Bangalore.
Bangalore
KARNATAKA 		 9865922802

ag.daf16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe,St Johns Medical College Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5% Hyperbaric levobupivacaine  Subarachanoid block using 1.8 ml of 0.5 % hyperbaric levobupivacaine with 25 mcg fentanyl in patients undergoing brachytherapy for gynecological malignancies. 
Comparator Agent  0.75% hyperbaric ropivacaine  Subarachanoid block using 1.8 ml of 0.75 % hyperbaric ropivacaine with 25 mcg fentanyl in patients undergoing brachytherapy for gynecological malignancies. 
Intervention  Subarachanoid block  Subarachanoid block will be given 10 minutes prior to brachytherapy 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Scheduled for brachytherapy in gynecological malignancy. 
 
ExclusionCriteria 
Details  Patients with allergy to local anaesthetics
patients with severe hepatic, renal and cardiac dysfunction
obese patients
patients with spinal abnormalities 
 
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 
a) Onset of sensory block.
b) Onset of motor block.
c) Highest level of sensory block
d) Side effects 		 Duration of sensory block(Time period from onset of block to the time of regression to S2)
Duration of motor blockade
(Time period from onset to Bromage scale 3 to 0. 
 
Secondary Outcome  
Outcome  TimePoints 
a) Onset of sensory block.
b) Onset of motor block.
c) Highest level of sensory block
d) Side effects 		 Time of onset of sensory block (time from intrathecal injection to time to achieve T10
segment level block)
Time of onset of motor block (Time from injection of study drug to the time to achieve
Bromage scale 3 i.e., patient is unable to move the hip, knee and ankle joint).
Time to highest level of sensory blockade.
Time for two segment regression of sensory level (time taken for regression of the block
to two dermatomal segments after injecting the drug). 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/11/2024 
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="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  

Brief Description Of The Intended Work

 

TITLE - Comparative study of effectiveness of intrathecal hyperbaric ropivacaine and hyperbaric levobupivacaine in combination with fentanyl in patients undergoing brachytherapy for gynecological malignancy.

           Brachytherapy is a procedure used for treatment of certain cancers which involves the placement of radioactive substances in or near a tumour. The procedure of insertion of radioactive implants for gynecological malignancy is extremely painful, so the patient needs to be immobile and requires optimal analgesia. Spinal anaesthesia is commonly administered for these procedures. 

                 Bupivacaine is widely used for spinal anaesthesia because of its long duration of action and its motor and sensory blockade. Newer analogues like levobupivacaine which is less cardiotoxic and ropivacaine which causes lesser motor blockade have been introduced into clinical practice. A few studies have shown in the efficacy of hyperbaric levobupivacaine and hyperbaric ropivacaine in gynecological, lower abdominal, urological and lower limb surgeries.

                However there are no studies comparing these drugs in patients undergoing brachytherapy, hence this study is being conducted to compare the efficacy of intrathecal hyperbaric ropivacaine and hyperbaric levobupivacaine in combination with fentanyl in patients undergoing brachytherapy for gynecological malignancy.

 

Primary objective: 

To study the duration of sensory and motor blockade in both levobupivacaine and ropivacaine group and time for two segment regression of sensory level.

Secondary objective:  To study 

a)     Onset of sensory block.

b)     Onset of motor block.

c)     Highest level of sensory block

d)     Side effects

Materials and methods

Source Of Data: St Johns National Academy Of Health Sciences, Bengaluru

Study Period: 2 Years

Study Design: Randomized Controlled Trial

Sample Size:  25 Per Group

 

a) SUBJECTS

Inclusion criteria

•          Patients aged between 20-70 years

•          Scheduled for brachytherapy in gynecological malignancy 

 Exclusion criteria

•          Patient with allergy to local anaesthetics.

•          Patients with severe hepatic, cardiac and renal dysfunction.

•          Obese patients, BMI >35.

•          Patients with spinal abnormalities.

The prospective, randomized, double blind study will be conducted after obtaining approval from Institutional Ethical Committee (IEC) and written informed consent 50 patients between the age of 20-70 scheduled for brachytherapy for gynaecological malignancy will be recruited for the study. 

Group L(n=25)- This group will receive 1.8ml of 0.5% hyperbaric Levobupivacaine+ 25 mcg of fentanyl intrathecally.

Group R(n=25)- This group will receive 1.8ml of 0.75% hyperbaric ropivacaine+ 25 mcg of fentanyl intrathecally.

      Hemodynamics- HR, SBP, DBP. MAP, SPO2 will be recorded.

The following parameters will be noted,

•          Duration of sensory block (time period from onset of block to the time of regression to S2)

•          Duration of motor blockade (time period from onset to Bromage scale 3 to 0.

•          Time of onset of sensory block (time from intrathecal injection to time to achieve T10 segment level block)

•          Time of onset of motor block (Time from injection of study drug to the time to achieve Bromage scale 3 i.e., patient is unable to move the hip, knee and ankle joint).

•          Time to highest level of sensory blockade.

•          Time for two segment regression of sensory level (time taken for regression of the block to two dermatomal segments after injecting the drug).

 
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