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CTRI Number  CTRI/2023/10/059198 [Registered on: 27/10/2023] Trial Registered Prospectively
Last Modified On: 26/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare effects of two heavy local anaesthetics in patients undergoing gynecological surgeries under spinal anaesthesia. 
Scientific Title of Study   Comparison of Hyperbaric Ropivacaine versus Hyperbaric Bupivacaine in subarachnoid block for gynecological surgery  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Devanshi Datta 
Designation  Postgraduate junior resident 
Affiliation  Government Medical College and Hospital, Chandigarh  
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh, India

Chandigarh
CHANDIGARH
160030
India 
Phone  7986192998  
Fax    
Email  devanshi.datta025@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jasveer Singh 
Designation  Professor  
Affiliation  Government Medical College and Hospital, Chandigarh  
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh, India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121664  
Fax    
Email  drjassy18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jasveer Singh 
Designation  Professor  
Affiliation  Government Medical College and Hospital, Chandigarh  
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh, India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121664  
Fax    
Email  drjassy18@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, GMCH , Chandigarh  
 
Primary Sponsor  
Name  Department of Anaesthesia and Intensive Care  
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5,GMCH,Sector 32 B , Chandigarh  
Type of Sponsor  Government medical college 
 
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 Devanshi Datta  Government Medical College and Hospital, Chandigarh   Department of Anaesthesia and Intensive care, Block D,Level 5,GMCH, Sector32 B,Chandigarh
Chandigarh
CHANDIGARH 
7986192998

devanshi.datta025@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (GMCH, Chandigarh)  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 
Comparator Agent  Hyperbaric Bupivacaine  Single injection of Hyperbaric Bupivacaine 15 mg in the subarachnoid space producing subarachnoid block for duration of 2.5 hours in total of 38 patients over a period of nearly 12 months. 
Intervention  Hyperbaric Ropivacaine   Single injection of Hyperbaric Ropivacaine 15 mg in the subarachnoid space producing subarachnoid block for duration of 2.5 hours in total of 38 patients over a period of nearly 12 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age group between 18-65 years
American Society of Anaesthesiologists (ASA) physical status I and II of either sex
BMI ≥ 20 to ≤ 35kg/m²
Duration of surgery upto 2-2.5 hours in gynecological surgeries (I.e Vaginal
hysterectomy, Cervical polypectomy, Tubal recanalisation, Myomectomy, Dilatation and
evacuation) 
 
ExclusionCriteria 
Details  Pre- existing local infection at the site of subarachnoid block
Patients with coagulopathy and platelet disorders
Contraindication or allergy to study drugs
Patients having pain in any other area than the surgery site
Patients having sensory or motor problem in the lower limb
Patients who failed to understand the VAS scoring system
Pregnant and lactating women
Patients with current history of psychiatric illness, communication difficulties  
 
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 
Comparison of duration of motor block after
injecting the drugs intrathecally
Assessment of sensory block will be done using
sterile pin prick method and motor block will be
assessed using Modified Bromage scale.
 
Time interval from onset of motor block to attainment of
complete movements (Bromage 0) in both lower limbs-motor blockade will be
assessed every minute for the first 10 minutes and thereafter every 10 mins during surgery
and every 15 minutes postoperatively. 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of onset of sensory and motor block, peak level, time to 2 segment regression,
duration of effective analgesia and any side
effects of drug or procedure 
Sensory and motor blockade will be
assessed every minute for the first 10 minutes and thereafter every 10 mins during surgery
and every 15 minutes postoperatively. 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   10/11/2023 
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 Yet Recruiting 
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   A total of 76 patients undergoing elective surgery will be randomly allocated to two groups of
38 patients each using computer generated random number table and the allotted number will
be secured in a coded opaque sealed envelope. The patients will be allocated to one of the
following two groups:
Group R (n=38): Patients will be given 3ml of 0.75% Hyperbaric Ropivacaine intrathecally
Group B (n=38): Patients will be given 3ml of 0.5% Hyperbaric Bupivaciane intrathecally

Procedure on day of surgery:

Patient will be shifted to the operation room. Monitoring of heart rate, systolic blood
pressure, diastolic blood pressure, mean arterial blood pressure, continuous
electrocardiogram, respiratory rate, and arterial oxygen saturation (Spo2) will be done using
multichannel monitor (Aespire view, GE Healthcare , Madison, WI, USA). Baseline values will be recorded.

After subarachnoid block has been given, assessment of sensory block will be done using sterile
pin prick method and motor blockade will be done using Modified Bromage scale. Assessment will
be done every minute for the first 10 minutes and then every 10 minutes during surgery and every
15 minutes postoperatively. Onset of both motor and sensory blockade will be assessed and
recorded. The highest dermatomal level of sensory blockade and recovery time of both sensory and
motor blockade will be recorded. Recovery time for the sensory blockade will be defined as the two
dermatome regression of anaesthesia from the maximal level. 

Patients with a VAS score of > 3 will receive rescue analgesia. The time of first
request for analgesia postoperatively will be recorded as total duration of spinal analgesia.
Patient will be monitored continuously intra and post operatively and observations will be recorded
in the prescribed proforma. 


 
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