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CTRI Number  CTRI/2025/08/093937 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 06/08/2025
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   In this study, in planned fullterm pregnant women undergoing cesarean section spinal anaesthesia with two different additives which to be compared administered. So the probable outcome maybe one drug is superior to another for post operative pain relief. 
Scientific Title of Study   Comparison of intrathecal Ropivacaine with Dexmedetomidine and Ropivacaine with Fentanyl in parturients undergoing elective LSCS. A double blinded randomised clinical study 
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 Ramesh Koppal 
Designation  Professor 
Affiliation  S.N.M.C and HSK hospital 
Address  Department of Anaesthesiology, S.N.M.C and HSK hospital, Navanagar, Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  9845504515  
Fax    
Email  rameshkoppaldr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramesh Koppal 
Designation  Professor 
Affiliation  S.N.M.C and HSK hospital 
Address  Department of Anaesthesiology, S.N.M.C and HSK hospital, Navanagar, Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  9845504515  
Fax    
Email  rameshkoppaldr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sampritha P G 
Designation  Junior Resident  
Affiliation  S.N.M.C and HSK hospital 
Address  Department of Anaesthesiology, S.N.M.C and HSK hospital, Navanagar, Bagalkot
Department of Anaesthesiology, S.N.M.C and HSK hospital, Navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India 
Phone  9606542219  
Fax    
Email  samprithapg@gmail.com  
 
Source of Monetary or Material Support  
Full term pregnant women coming to S N Medical college and HSK hospital posted for elective caesarean delivery under spinal anaesthesia. 
 
Primary Sponsor  
Name  S Nijalingappa Medical College 
Address  Department of Anaesthesiology, Second floor,S.N.M.C and HSK hospital, Navanagar, Bagalkot 
Type of Sponsor  Private 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 Ramesh Koppal  HSK Hospital,S Nijalingappa Medical College,Bagalkot  S N Medical College and H S K Hospital, ground floor Obstetric OT Complex.
Bagalkot
KARNATAKA 
09845504515

rameshkoppaldr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S Nijalingappa Medival College And Hanagal Shri Kumareshwar Hospital And Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnancy 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Elective cesarean,comparing two intrathecal drugs.   In elective LSCS, Ropivacaine with Dexmedetomidine and Ropivacaine with Fentanyl will be compared for post op analgesia, shivering and hemodynamic stability. 
Intervention  Elective LSCS intrathecal administration of two different additives mixed with Ropivacaine.  We are adding Dexmedetomidine and Fentanyl to Ropivacaine to study the postoperative analgesia , hemodynamic stability and shivering. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Age group :21 to 45 years women having gestational age more than 37 weeks.
2. Elective caesarean deliveries done under Spinal Anaesthesia.
3. ASA (American Society Of Anaesthesiologists) physical status II and III.

 
 
ExclusionCriteria 
Details  1.Refusal to Enrol for the study
2.Any contraindications for spinal anaesthesia
3.Multifetal gestation
4.Eclampsia
5.Obesity BMI more than 35kg/m2
6.Short stature
7.Uncontrolled medical illness like cardiac diseases, renal diseases and anemia
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Administering intrathecal inj Dexmedetomidine with inj Ropivacaine probably has better analgesic effect when compared to intrathecal administration of inj Fentanyl with inj Ropivacaine.  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Compared to Fentanyl, Dexmedetomidine may provide better hemodynamic stability and risk of intra and post operative shivering is lesser  24 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/10/2025 
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="6"
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  
 Ropivacaine presents several advantages over bupivacaine for spinal anesthesia in cesarean sections, making it a safer and potentially more  effective option. It has lower cardiotoxicity and neurotoxicity, enhancing both maternal and fetal safety - an important factor in obstetric care. Ropivacaine provides comparable sensory block with significantly less motor blockade,promoting faster postoperative recovery and improved maternal mobility. It causes less maternal hypotension due to a more favorable sympathetic block profile further supporting its suitability for  cesarean delivery. 
Post operative pain after cesarean section can impact early recovery , breastfeeding and maternal  wellbeing. Intrathecal adjuvants like Fentanyl and Dexmedetomidine when combined with Ropivacaine , are used to enhance analgesia, but their comparative effectiveness remains unclear. This study aims to evaluate and compare the duration of post operative analgesia in parturients receiving intrathecal Ropivacaine with either  Dexmedetomidine or Fentanyl , to help guide optimal pain management strategies.
 Fentanyl enhances  analgesia without increasing motor or sympathetic block, reducing hypotension and allowing earlier recovery and  mobilization. 
Dexmedetomidine, a highly selective alpha 2 agonist with  eightfold higher receptor affinity than Clonidine, though  FDA approved for intravenous sedation in ICUs, it is being used intrathecally to  prolong analgesia without significant sedation .This study aims to assess its efficacy with  0.75 percent hyperbaric Ropivacaine, hypothesizing prolonged  analgesia,  improved intraoperative block, minimal motor block, and negligible side effects. 
 Shivering during cesarean can cause up to 200 times increased oxygen demand, cardiovascular stress leading to Myocardial Infarction , impaired monitoring and  wound discomfort intraoperatively. Postoperatively, it may delay recovery, raise infection risk, and increase intracranial or intraocular pressure. Prompt management helps prevent these complications and ensures better patient outcomes. IV Dexmedetomidine (0.5–1.0 µg/kg) effectively prevents it. While its intrathecal effect on shivering is unstudied, this double-blind trial evaluates its potential benefit during caesarean section with hyperbaric ropivacaine .

Primary Objective:
To study the duration of post operative analgesia using visual analogue score (VAS Score) in parturients undergoing elective LSCS.

Secondary Objectives:
1. To study the intensity and severity of shivering using a four point scale in parturients undergoing elective LSCS.
2.To study the duration of motor blockade using modified bromage score in parturients undergoing elective LSCS.
3. To study the hemodynamic parameters in parturients undergoing elective LSCS.

Methodology
60 Full-term parturients aged 21-45 years, with American Society of Anaesthesiologists (ASA) physical status ll and lll, who will be scheduled for lower-segment cesarean delivery with subarachnoid block will be included after written informed consent.
Block randomization will be performed using a computer generated block random number table to randomly assign 60 full-term parturient into two groups. The allocation sequence is concealed within sealed envelopes and opened by anaesthesiologist who will not be involved in the investigation. The study solutions will be prepared under sterile conditions in advance and enclosed within masked 2.5 ml syringes according to randomisation to maintain blinding. The treatment group will remain unkno;wn to the anaesthesiologist monitoring the patient.The two groups will be designated as follows: group RD , which will receive intrathecal 0.75% hyperbaric Ropivacaine 2 ml plus Fentanyl 20 mcg.
As per institutional protocol, parturient will be fasted prior to surgery as per ASA guidelines, intravenous access will be established using an 18G iv canula with all parturients receiving a coload (10 ml/kg of crystalloid balanced solution) and inj Pantoprazole 40 mg iv, inj Ondansetron 4mg iv given 30 min prior to surgery. Pregnant women will be shifted to OT , all ASA standard monitors like pulse oximetry, non-invasive blood pressure cuff and electrocardiogram will be attached and baseline hemodynamic parameters will be recorded.
Spinal anaesthesia will be administered in the sitting position using a 26 G quincke spinal needle under strict aseptic and antiseptic precautions after giving local anaesthesia in l3-l4 intervertebral space. all parturients receive 2.4 ml of the drug, regardless of their study group.
After intrathecal injection, patients are positioned supine, a wedge is placed under right buttock to prevent IVC compression by gravid uterus and hemodynamic parameters are recorded for every 1 minute for first 10 minutes and every 5 minute interval until the surgery is concluded, followed by every 30 min for 6 hours during the postoperative period followed by every 2 hrs upto 24 hrs after the surgery concluded. A SBP below 90 mmHg or a drop of more than 20 percent from the basal systolic pressure is referred to as hypotension. Hypotension is managed with Inj Mephentermine 6 mg IV and repeated if necessary. Bradycardia, which is defined as a heart rate below 50 beats per minute, is managed with Inj Atropine 0.6 mg IV.

Pain assessment is done with the help of vas score
Pain assessment will be done for the first 24 hrs
Rescue analgesia- inj  Paracetamol 1g and inj Diclofenac 75mg will be given. If required  inj Tramadol 100 mg will be given.
Modified Bromage Score
0- The patient is able to move hip, knee and ankle
1- Patient is unable to move hip but able to move knee and ankle
2- Patient is unable to move hip and knee but able to move ankle
3-Patient is  unable to move hip, knee and ankle.
Shivering is graded using a four point scale
None- no perceptible tension of muscles observed
Mild- slight muscle tonus of masseter muscle
Moderate- shivering of proximal muscles
Severe- generalised  shivering of whole body 


 
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