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CTRI Number  CTRI/2025/05/086095 [Registered on: 01/05/2025] Trial Registered Prospectively
Last Modified On: 01/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effectiveness of Dexamethasone and magnesium sulphate with ropivacaine for post operative pain assessment in lower segment cesarean section patients using an ultrasound to guide the injection to abdominal muscles. 
Scientific Title of Study   Magnesium sulphate vs Dexamethasone as an adjuvant to ropivacaine in ultrasound guided transverse abdominis plane block as post operative analgesia in lower segment cesarean section patients.A randomised clinical comparative 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  Divya kesarapu 
Designation  Post graduate student 
Affiliation  Institute of medical sciences and SUM hospital  
Address  Department of Anesthesiology, IMS & SUM hospital, Siksha O Anusandham University, Bhubaneswar,Khorda. Khordha ORISSA 751003 India

Khordha
ORISSA
751003
India 
Phone  7901001428  
Fax    
Email  divyakesarapu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrRanjita acharya 
Designation  Professor 
Affiliation  Institue of medical science and sum hospital 
Address  Department of Anesthesiology, IMS & SUM hospital, Siksha O Anusandham University, Bhubaneswar,Khorda. Khordha ORISSA 751003 India

Khordha
ORISSA
751003
India 
Phone  8763421899  
Fax    
Email  drranjitaacharya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Divya kesarapu 
Designation  Post graduate student 
Affiliation  Institue of medical science and sum hospital 
Address  Department of Anesthesiology, IMS & SUM hospital, Siksha O Anusandham University, Bhubaneswar,Khorda. Khordha ORISSA 751003 India

Khordha
ORISSA
751003
India 
Phone  7901001428  
Fax    
Email  divyakesarapu@gmail.com  
 
Source of Monetary or Material Support  
IMS & SUM hospital,Siksha O Anusandham University,Bhubaneswar,Khorda, 751003, India  
 
Primary Sponsor  
Name  Institue of medical science and sum hospital 
Address  K8,Kalinganagar,Bhubaneswar,Odisha, 751003,India 
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 Divya kesarapu  Institute of medical sciences,siksha O Anusandhan  Department of Anaesthesia, OBGY OT, k8 kalinga nagar, Bhubaneswar,odisha, 751003 Khordha ORISSA
Khordha
ORISSA 		 7901001428

divyakesarapu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, IMS & SUM Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pain scoring in elective lower segment cesarean section. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexamethasone 8 mg with ropivacaine 0.25%  Transverse abddominis plane block will be given with 8 mg dexamethasone and 0.2% ropivacaine, given immediately in the post-operatively following elective lower segment cesarean section and the pain score will be assessed 2,4,6,8,12,24 hours using visual analogue score 
Intervention  Magnesium sulphate 250 mg with ropivacaine 0.25%  Transverse abdominis plane block will be given with 250 mg magnesium sulphate with 0.2% ropivacaine , given immediately in the post-operatively following elective lower segment cesarean section and the pain score will be assessed 2,4,6,8,12,24 hours using visual analogue score for a duration of 24 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patients posted for elective Lower segment caesarean section without any other comorbidities and primigravida patients and patient within the age group of 18 to 40 years,Patients under ASA 1&2 ,Patients who have given informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  Patients refusal, with multiple gestations, emergency lower segment cesarean section and patients requiring general anaesthesia and Patients with known allergy or contraindication to Ropivacaine, Magnesium Sulphate or Dexamethasone,Patients with a history of chronic pain or on chronic analgesic therapy,Pre eclampsia patient who received magnesium sulphate therapy,Patients with coagulopathy or on anticoagulant therapy, chronic use of steroid therapy, Patients with infection at the injection site or generalized sepsis,Patients with a Body mass index more than 35,Patients with neurological or psychiatric disorders affecting pain perception or reporting,Patients with pregnancy related complications such as preeclampsia, eclampsia, diabetes mellitus , gestational diabetes, and who are unwilling or unable to comply with post-operative pain assessments,patients with renal, cardiovascular diseases,contraindication to subarachnoid block 
 
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 
To evaluate the duration of analgesia of dexamethasone and magnesium sulphate as an adjuvant to 0.2% ropivacaine in Ultrasound Guided Transverse Abdominus Plane Block in Lower segment caesarean patients
 		 2,4,6,8,12,24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the pain scores using a standardized pain scale Visual analogue score at various time intervals post operatively,To measure total doses of rescue analgesia intake in first 24 hours post operatively,To monitor hemodynamic variables-systolic blood pressure,Diastolic blood pressure,Mean arterial pressure,Heart rate,Saturation,To observe any side effects  due to drugs
 		 2,4,6,8,12,24 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/05/2025 
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="7" 
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  
  1. The study is a randomized, double blinded, clinical comparative study will be conducted at our institution in obstetrics operations theatre with a study population of 100 patients.
  2. All the data collected will be entered in Microsoft excel 2007 and further analyses in SPSS version-27.categorised variables will be expressed in numericals and percentage.continuous variable will be expressed by chi-square /fischer extract test.comparison between two means will be assessed by using T test /mann Whitney.
  3. P value < 0.05 will be constant.
  4. Sample size-100
  5. Consent for Transverse abdominis plane block will be taken from each patient prior to their elective surgery and will be randomized into two groups 50 in each.
  6. All the patients will be nill per oral  fast for at least 6 hours prior to the procedure.
  7. All the routine monitors will be attached and the preoperative baseline readings of noninvasive blood pressure, (NIBP), pulse rate (PR), and saturation (SPO2) will be noted. 
  8. After securing an intravenous access using an 18-Gauge IV cannula all patients irrespective of the group they belonged to will be preloaded with Ringer’s lactate 10 mL/kg over 15 min.
  9. All patients will be administered spinal anesthesia with 0.5% hyperbaric bupivacaine of 2.2 -2.5ml using 25G Quincke’s needle in sitting position under strict aseptic precautions. 
  10. Bilateral ultrasound guided posterior TAP block will be administered postoperatively immediately following surgery , drugs will be  prepared by the attending anesthesiologist supervising the block and given unlabeled to the anesthesiologist who completed the block . 
  11. A linear transducer is placed in the axial plane in the mid-axillary line and moved posteriorly to the most posterior limit of the TAP between the internal oblique and transversus abdominis muscles.
  12. The needle will be inserted in the mid-axillary line and advanced posteriorly until it reaches the posterior end of the TAP where local anesthetic will be injected.
  13. The in-plane technique with a 22G 80mm block needle will be used to inject 20 ml of 0.2% Ropivacaine combined with either 8 mg dexamethasone or  250 mg magnesium sulphate into the transverse abdominus plane on each side, bilaterally will be administered.
  14. IV paracetamol 15mg/kg analgesics will be given at the end of the surgery.Patients will be shifted to postoperative ward for monitoring.Patient will  be allowed to take orally  4 hrs after surgery.
  15. Pain scores using the visual analogue scale (VAS) will be assessed at 2,4,6,8,12, and 24- hours to determine the post-block pain Scores. Rescue drug Tramadol will be given intravenously 50 mg IV when pt have VAS >4. 
  16. Hemodynamic parameters like noninvasive blood pressure, heart rate, saturation,  will be monitored at—2,4,6,8,12,24 hrs along with Nausea, vomiting, bradycardia and respiratory depression.
 
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