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CTRI Number  CTRI/2024/04/065125 [Registered on: 03/04/2024] Trial Registered Prospectively
Last Modified On: 28/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of intravenous steroid vs perineural steroids as an additive in abdominal plane blocks in patient undergoing cesarian section - A Clinical trail  
Scientific Title of Study   Efficacy of intravenous versus perineal dexamethasone as an adjuvant in transverse abdominis plane block for post operative analgesia following elective cesarean section - A randomised double blinded clinical trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nithin K 
Designation  Post graduate student 
Affiliation  Sri Balaji vidyapeeth 
Address  211, department of anaesthesiology, Mahatma Gandhi medical college and research institute, Pillaiyarkuppam, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  8489332550  
Fax    
Email  nithin.nash15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gayatri mishra 
Designation  Professor 
Affiliation  Sri Balaji vidyapeeth 
Address  211, department of anaesthesiology, Mahatma Gandhi medical college and research institute Pillaiyarkuppam, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  8489332550  
Fax    
Email  drgayatrimishra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nithin K 
Designation  Post graduate student 
Affiliation  Sri Balaji vidyapeeth 
Address  211, department of anaesthesiology, Mahatma Gandhi medical college and research institute, Pillaiyarkuppam, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  8489332550  
Fax    
Email  nithin.nash15@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi medical college hospital and research institute , pillayarkuppam, puducherry, India 607402 
 
Primary Sponsor  
Name  Nithin K 
Address  Mahatma Gandhi medical college and research institute Periyakattupalayam, Pondicherry. 607402 
Type of Sponsor  Other [Self] 
 
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 
Nithin K  Mahatma Gandhi medical college and research institute   Department of anaesthesiology
Pondicherry
PONDICHERRY 
8489332550

nithin.nash15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi medical college and research institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O759||Complication of labor and delivery, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous dexamethasone  Inj.Dexamethasone of 8mg (2ml) will be given along with bilateral TAP block via interavenous route, the drug will be administered only once 
Comparator Agent  Perineural dexamethasone  Inj.dexamethasone of 8mg (1ml on each side) will be added with the local anaesthetic given along with the bilateral TAP block. The drug will be administered once 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.All pregnant women
2.ASA II patients
 
 
ExclusionCriteria 
Details  1.Allergy to local anaesthetic drugs
2.Seizure disorders
3.Any intraoperative surgical complications
4.Prolonged duration of labour
5.If caesarean section is done under general anaesthesia
6.Dexamethasone Used During Intra Operative period
7.Patients having gestational diabetes mellitus
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the duration of analgesia.  At baseline, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess & compare the static & dynamic post-op pain scores at 0, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours using visual analog scale.

 
Baseline, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours 
To assess & compare the loss of sensation to cold & touch in the abdominal wall dermatomes from T9 to L1, in the midline & midclavicular lines on both sides.  Baseline, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours 
To assess & compare the time to first analgesic requirement.  8 hours & 12 hours 
To measure the 24-hour cumulative rescue analgesic consumption.  24 hours 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   10/04/2024 
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  

Cesarean delivery (CD) is one of the most commonly performed lower abdominal surgeries. CD pain has both a somatic component due to the surgical incision and a visceral component due to uterine contractions. Blocking both components leads to decreased maternal morbidity, early mobilization,and increased patient satisfaction.

The infra-umbilical portion of the anterior abdominal wall is supplied by T7-L1 nerves, which travel in the plane between the transverse abdominus muscle and the internal oblique muscle- the transversus abdominis plane (TAP).The nerves in addition give out a lateral cutaneous branch, which arises proximal to the angle of the rib, runs a short distance with the main nerve, and emerges obliquely through the overlying muscles in the mid axillary line to supply the respective dermatomes. The transverse abdominal plane (TAP) block, is used to block these nerves and their branches in the TAP. 

Dexamethasone is a synthetic glucocorticoid with anti-inflammatory and immunosuppressive properties. With 20 to 30 times the binding affinity for glucocorticoid receptors of endogenous cortisol, which causes vasoconstriction and reduce absorption of administered local anesthetic, decreases the inflammatory response and blocking k + channel used for pain transmission and transduction. Various studies have been done in dexamethasone for prevention of post-operative nausea and vomiting (PONV) in caesarean section.Even though dexamethasone is one of the most commonly used antiemetics, its mechanism of action remains unclear. Post-operative pain relief using dexamethasone as an adjuvant in perineural TAP block has been studied in caesarean sections. IV dexamethasone has been studied for post-operative pain management in patients undergoing caesarean section.Various studies have been done comparing IV dexamethasone and perineural dexamethasone for post-operative pain relief in peripheral nerve block, supraclavicular blockinterscalene block

 

A literature search revealed that there is only one study related to comparing IV dexamethasone and dexamethasone as adjuvant in the TAP block in elective LSCS and that was done without using ultrasound guidanceThere is lack of study using ultrasound guided TAP block, Hence this study is being done to compare the ultrasound guided TAP block using dexamethasone as an adjuvant to 0.25% bupivacaine and IV dexamethasone for post-operative analgesia following elective caesarean section

 
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