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CTRI Number  CTRI/2024/04/065962 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 19/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Injection Bupernorphine with intrathecal injection Ropivacaine for intensity of pain relief in Cesarean section patients 
Scientific Title of Study   Comparison of different doses of injection Bupernorphine with intrathecal injection Ropivacaine in Cesarean section patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Vide BCR-RPD-01, Version no. 2.0, dated 19-09-2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Veena Narayan Wetal  
Designation  Assistant Professor  
Affiliation  Assistant Professor 
Address  Department of Anesthesiology and Critical Care, 6th floor, Grant government medical college, Nagpada
Department of Anaesthesia, Grant government medical college, Mumbai 400008
Mumbai
MAHARASHTRA
400008
India 
Phone  7875447697  
Fax    
Email  drveena2307@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Veena Narayan Wetal  
Designation  Assistant Professor  
Affiliation  Assistant Professor 
Address  Department of Anesthesiology and Critical care, 6th floor, Grant government medical college & Sir JJ group of hospitals, Mumbai
Grant government medical college, Mumbai 400008
Mumbai
MAHARASHTRA
400008
India 
Phone  7875447697  
Fax    
Email  drveena2307@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Veena Narayan Wetal  
Designation  Assistant Professor  
Affiliation  Assistant Professor 
Address  Department of Anesthesiology and Critical Care, 6th floor, Grant government medical college, Nagpada, Mumbai
Grant government medical college, Mumbai 400008
Mumbai
MAHARASHTRA
400008
India 
Phone  7875447697  
Fax    
Email  drveena2307@gmail.com  
 
Source of Monetary or Material Support  
Grant government medical college, Mumbai 400008 
 
Primary Sponsor  
Name  Department of Anesthesiology and Critical Care  
Address  Grant government medical college & Sir JJ group of hospitals, Mumbai, Maharashtra, India. Pin code 400008 
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 Veena Narayan Wetal   Sir JJ group of hospitals   GGMC and Sir JJ group of hospitals, Byculla
Mumbai
MAHARASHTRA 
7875447697

drveena2307@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Grant government medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention - Spinal anaesthesia with intrathecal injection Ropivacaine Comparator agent - Injection Bupernorphine  Spinal anaesthesia in LSCS patients will be used once on induction of Anaesthesia. Different groups are Group A: 1.8ml of hyperbaric 0.75% Ropivacaine with 30 microgram injection Bupernorphine Group B: 1.8ml of hyperbaric 0.75% Ropivacaine with 60 microgram injection Bupernorphine Group C: 2 ml of hyperbaric 0.75% plain injection Ropivacaine will be used intrathecally for Spinal anaesthesia 
Intervention  Intervention - Spinal anaesthesia with intrathecal injection Ropivacaine Comparator agent - Injection Bupernorphine   Spinal anaesthesia in LSCS patients will be used once on induction of Anaesthesia. Different doses of additive injection Bupernorphine 30 microgram and 60 microgram will be used to improve the efficacy of intrathecal Ropivacaine; 30u injection Bupernorphine & 60u of injection Bupernorphine with plain injection Ropivacaine will be used intrathecally for Spinal anaesthesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patients undergoing Elective Caesarean section
ASA I/II
Height between 145-160 cm
Pregnant pregnancy weight between 45- 80 kg 
 
ExclusionCriteria 
Details  Patients with coagulopathy; Patients with severe PIH, Pre-Eclampsia or Eclampsia; Patients with hepatic, cardiac, renal or neurological disease.
Patients not willing for spinal anaesthesia  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To study effect of intrathecal hyperbaric Ropivacaine 0.75% 2ml compared to intrathecal hyperbaric Ropivacaine 0.75% with two different dosage of Bupernorphine 30ug & 60ug for characteristics of sensory and motor blockade. And also the postoperative analgesia duration and analgesic requirements.  4 mths 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters
Complications
APGAR score 
3-4 months  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 3/ Phase 4 
Date of First Enrollment (India)   30/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
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 the method of choice for caesarean section especially in casc of clective procedures because it avoids the most common risks associated with G cneral Anacsthesia such as aspiration, difficult intubation and negative effccts of general anaesthetics on the fetus. However, certain side effects may also result from spinal anaesthesia, common being hypotension caused by the preganglionic sympathetic block. A decrease in systolic pressure can compromise uterine blood flow and fetal circulation, and thus cause fetal hypoxia and acidosis

Ropivacaine has been introduced for clinical use in 1996 (2009 in India). It isa amide pure S-type I-hydrochloric acid isomer and has low central nervous system toxicity and cardiotoxicity. In moderate drug concentrations, ropivacaine can produce the separation of mctor and sensory nerve block , Domestic studies have shown that a total dose of 10-22.5 mg of 0.5% ropivacaine is safe and reliable, and a lower dose should be selccted for older patients . This anesthesia scheme has the advantages ,of satisfactory analgesia, stabłe intraoperative hemodynamics, a low incidence of postoperative complications and early ambulation postoperatively"".

Opioids remain the mainstay among the various adjuvants to local anesthetics (LAs) in SAB primarily by virtue of its various properties such as reducing thc dose cf LA, minimizing side cffects, and prolonging the duration of anesthesia. American Society of Anesthesiologists (ASA) recommends neuraxial opioids over intermittent administration of parcntcral opioids for postoperative anaigesia after neuraxial anesthesia for caesarcan section." As sInaller doses are used intrathecally, neonatal drug transfer is negligible conıpared to epidural or parenterai opioids*". To overcome disadvantages like spinal hypotension and shivcring many kind of adjuvants have been used intrathecally like fentany sufentanil, dexmedetomidine0, buprenorphine,,,), Nalbuphine,0 clonidine etc. for spinal anaesthesia in LSCS patients. Different additives have been used to improve the efficacy of intrathecal Ropivacaine. However these adjuvants ure associated with urdesired side effects.

Buprenorphine is an agonist-artagonist opioid, about thirty times more potent tỉhan morplıine. It is a -centrally acting iipid soluble analog of the alkaloid thebainc with both spina! and supraspinal coinpoıents of anaigesia. In addition, it has a ceiling cfiect on respiratory depression but not on analgesia. The antihyperalgesic property of buprencrphine helps in preventing centra! sensitization. Its high lipid solubity, high affinity for epioid receptors, and long duration of action makes buprenorphine a good choice as an adjuvant to intrahecal LA for managing moderate to severe postoperat:ve pain. Buprenorphine is readily available as a preservative-free preparation which is compatible with the cerebrospinal fluid (CSr). Intrathecal doses (30 ug-150 ug) arc much smaller than parenieral doses and are known to prolong analgesia without sensory or motor blockade. Being more lipophilic than morphine, buprenorphine has low medullary bioavailability after neuraxial administration so that the occurrence of side cffects is lesser, making it an attractive altenative2)

Postoperative pain is a major causc of fear and anxiety in hospitalized patients and so if patients reinain pain-free during this period, they can cooperate with the circumstances well, leading to early recovery. Over the last two decades, there has been considerable revival of interest in the use of regional anesthesia techniques for surgery and pain management. Yet a gold standard method has not been determined which will have all desired effects during caeserean section without much of adverse effects on maternal and neonatal morbidity.

In this study, optimal dose of Bupcrnorphine which provides a balance betwecn analgesia and adverse effects was been studied in patients for cesarean section. The aim of this study was to compare the efficacy of two doscs uf buprenorphine (30 ug and 60 ug) as an adjuvant to hyperbaric Ropivacaine for postopcrative analgesia in cesarean section. The side cffect profile of neuraxial buprenorphine on the mother and the newbom in the early postopcrative period was also assessed.
 
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