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CTRI Number  CTRI/2024/05/067057 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Spinal anaesthesia with two different drugs as adjuvants in cesarean section 
Scientific Title of Study   A prospective observational study of intrathecal hyperbaric ropivacaine with nalbuphine or dexmedetomidine as adjuvants for cesarean section  
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 Bharanidharan  
Designation  2nd year anaesthesia resident 
Affiliation  Government medical College surat new civil hospital surat  
Address  2nd Floor, Old college building, Department of Anesthesia, Government Medical college-Surat, near Majura gate Surat GUJARAT 395001 India

Surat
GUJARAT
395001
India 
Phone  9514277481  
Fax    
Email  bharani4811156@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Bansari N kantharia 
Designation  Additional professor  
Affiliation  Government medical College surat new civil hospital surat  
Address  2nd Floor, Old college building, Department of Anesthesia, Government Medical college-Surat, near Majura gate Surat Gujarat India 395001 India

Surat
GUJARAT
395001
India 
Phone  9825690177  
Fax    
Email  bansarikantharia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Bansari N kantharia 
Designation  Additional professor  
Affiliation  medical College surat new civil hospital surat  
Address  2nd Floor, Old college building, Department of Anesthesia, Government Medical college-Surat, near Majura gate Surat Gujarat India 395001 India

Surat
GUJARAT
395001
India 
Phone  9825690177  
Fax    
Email  bansarikantharia@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
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 
DrBharanidharan  New civil hospital surat   First floor operation theatre, Obstetrics and gynaecology theatre,Civil hospital surat,Near majura gate surat,Gujarat India
Surat
GUJARAT 
9514277481

bharani4811156@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human research ethics committee GMC SURAT   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patients posted for elective or emergency caesarean section receiving spinal anaesthesia Patients in the age group of 18-40 years
Patients belonging to ASA grade I, II or III
Patients giving written informed consent 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Onset and duration of sensory & motor blockade
Duration of post operative analgesia and 24 hours analgesic requirement 
24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Sensory assessment: pin prick method
Modified Bromage scale
Apgar score
Visual analogue scale score for pain
Ramsay sedation score  
Till 24 hrs after spinal anaesthesia  
 
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)   17/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/05/2024 
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   Spinal anaesthesia is technique of choice for anaesthesia in patients undergoing caesarean section due to its rapid onset, decreased blood loss intense analgesia ,awake mother to permit bondage between mother and newborn,allowing early breastfeeding,early ambulation to the mother and minimizes the incidence of deep vein thrombosis while avoiding the complications of general anesthesia¹.The limitations of single shot spinal anaesthesia are it’s short duration of action and the need to supplement with parentral analgesics in the immediate post operative period .Several adjuvants have been added to prolong the duration of single shot spinal anaesthesia such as fentanyl, Dexmedetomidine, nalbuphine,clonidineetc...It has been added to local anesthetics to improve the quality of blockade and also to prolong the duration of post operative analgesia. 
   Ropivacaine has a lower central nervous and cardiac toxic potential than bupivacaine .Additionally ropivacaine is less potent and causes shorter duration of motor blockade than bupivacaine.Thus,hyperbaric ropivacaine is usually used for cesarean section ². Short duration of Ropivacaine cannot prevent visceral pain so analgesia supplementation in the intraoperative period or early analgesic intervention in the post operative period is often required.
   Nalbuphine is highly lipid soluble opioid with agonist at ĸ receptors and weak agonist and antagonist at µ receptor. It is without significant effects on delta receptor. Nalbuphine has the potential to maintain or even enhance mu opioid based analgesia while simultaneously mitigating the common mu-opioid side effects. Nalbuphine elicits analgesia through a complex interaction of supraspinal ĸ3 and spinal ĸ1 mechanism and provides potent analgesia at spinal level.Nalbuphine acts primarily at the level of the first synapse in the nociceptive system in producing analgesia³. The respiratory depression is lesser than other opiods and has a safety profile with minimal effect on cardiovascular function and other side effects like nausea, vomiting ,constipation and psychotomimetic effects. It has minimal haemodynamic effects.
      Dexmedetomidine is a highly selective alpha 2 adrenoceptoragonist,sedative,anxiolytic,analgesic,sympatholytic and antinociceptive characteristics.It mediates central alpha 2A and imidazoline type 1 receptors activation which results in decrease of norepinephrine release and leads to decrease in blood pressure and heart rate² .Both primary analgesic effects and potentiation of opioid induced analgesia result from activation of alpha 2 adrenergic receptors in dorsal horn of spinal cord and inhibition of substance P release and it’s hallmark is its analgesic efficacy without any respiratory depression .So far to my knowledge there is no study comparing hyperbaric ropivacaine with nalbuphine and Dexmedetomidine.
 
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