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CTRI Number  CTRI/2022/09/045818 [Registered on: 23/09/2022] Trial Registered Prospectively
Last Modified On: 15/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   To compare the effectiveness of dexamethasone and Magnesium sulphate as add on with Ropivacaine 0.25% in transversus abdominis plane block using ultrasound in pregnant patients undergoing operation for delivery. 
Scientific Title of Study   Comparison of Bilateral Ultrasound guided Transversus abdominis plane block with dexamethasone and Magnesium sulphate as an adjuvant with Ropivacaine (0.25%) in patients undergoing lower segment cesarean section under subarachnoid block – A prospective randomized double blinded study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrRaghavi  
Designation  1st year anesthesia pg 
Affiliation  chettinad hospital and research institute 
Address  Department of Anesthesiology and critical care. Chettinad health city,Rajiv Gandhi salai,kelambakkam, chengalpattu

Chennai
TAMIL NADU
603103
India 
Phone  9840535444  
Fax    
Email  dr.raghavi96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrBBalamurugan  
Designation  Professor 
Affiliation  Chettinad hospital and research institute 
Address  Department of Anesthesiology and critical care. Chettinad health city,Rajiv Gandhi salai kelambakkam,chengalpattu

Chennai
TAMIL NADU
603103
India 
Phone  9841544566  
Fax    
Email  drbala.srmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrRaghavi  
Designation  1st year anesthesia pg 
Affiliation  chettinad hospital and research institute 
Address  Department of Anaesthesiology and critical care. Chettinad health city, Rajiv Gandhi salad,kelambakkam, chengalpattu

Chennai
TAMIL NADU
603103
India 
Phone  9840535444  
Fax    
Email  dr.raghavi96@gmail.com  
 
Source of Monetary or Material Support  
Chettinad Hospital and Research Institute  
 
Primary Sponsor  
Name  DrRaghavi 
Address  Chettinad health city,Rajiv Gandhi salad,kelambakkam  
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 
DrRaghavi  Chettinad hospital and research institute.   Department of anesthesiology and critical care. Chettinad health city, rajiv gandhi salai,kelambakkam,chengalpattu
Chennai
TAMIL NADU 
9840535444

dr.raghavi96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CARE IHEC -1  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  Bilateral Ultrasound guided Transversus abdominis plane block.   The bilateral TAP block will be performed after skin closure under monitoring with ultrasound guidance ( a high frequency linear probe) with needle in-plane technique , wherein the 23G Quincke’s spinal needle will be inserted between the mid and anterior axillary line extending below the rib line to the highest point of the iliac crest under aseptic precautions. 
Comparator Agent  Ropivacaine 0.25% with Dexamethasone 8mg,20ml on each side over 15-20 minutes based on technical difficulties.   Bilateral Ultrasound guided Transversus abdominis plane block with Ropivacaine 0.25% with Dexamethasone 8mg,20ml on each side over 15-20 minutes based on technical difficulties.  
Comparator Agent  Ropivacaine 0.25% with Magnesium sulphate 1gram ,20ml on each side over 15-20 minutes based on technical difficulties.   Bilateral Ultrasound guided Transversus abdominis plane block with Ropivacaine 0.25% with Magnesium sulfate 1gram,20ml on each side over 15-20 minutes based on technical difficulties.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  American society of Anaesthesiologist (ASA I AND II)
Patients undergoing elective and emergency lower segment cesarean section surgeries under spinal anesthesia. 
 
ExclusionCriteria 
Details  patient refusal
allergy to study drug
local site infection
coagulopathy
altered mental status
PIH patients on magnesium. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of analgesia between both the groups.  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
to compare the total amount of analgesia required in first 24 hours  24 hours 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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 
Date of First Enrollment (India)   30/09/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.raghavi96@gmail.com].

  6. For how long will this data be available start date provided 01-01-2023 and end date provided 01-01-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

·              Lower segment cesarean section (LSCS) may result in significant postoperative pain, which can negatively impact ambulation, breastfeeding, and even maternal bonding. Pain after LSCS has a somatic component arising from nociceptors within the surgical wound and a visceral component originating from muscles.Inadequate postoperative analgesia after cesarean delivery delays ambulation with subsequent increased risk of thromboembolism, and harms motherbabyrelationship(1) .Goal standard for postoperative pain is opioids whether administered systemic or neuraxial but it is associated with manyside effects such as nausea, vomiting, pruritus, constipation, and respiratory depression(2). Multimodal approach of postoperative analgesia which combines parenteral analgesics with regional analgesic techniques may enhance analgesia of each component and decrease its side effects.(3)

 

·              Transversus abdominis plane (TAP) block represents one of the most widely used regional analgesic techniques and important component of multimodal approach for postoperative analgesia.(4)Transversus abdominis plane (TAP) is a neurovascular plane between the internal oblique muscle and the transversus abdominis muscle through which pass the nerves supplying the anterolateral abdominal wall(5).Application of the local anesthetics in this plane will produce myocutaneous sensory block between T6 and L1 (TAP) block which is suitable for pain relief in abdominal surgeries(6).TAP block was described for the 1st time by Rafi in 2001; he called the technique as refined abdominal field block. TAP block hasbeen used successfully as an important element of multimodal postoperative analgesia for many abdominal procedures such as cholecystectomy, gynecological laparoscopy, appendectomy, nephrectomy, and cesarean delivery(7).Establishment of TAP block requires injection of large dose of LA in this relatively vascular plane which leads to potential neurotoxic plasma level of the LA ,specially during pregnancy which increases susceptibility of the pregnant women to local anesthetic toxicity.(8)

 

·              Ropivacaine is longer acting than lignocaine and has a documented better safety profile than bupivacaine. It is common practice nowadays to use ropivacaine for nerve blocks and fascial plane blocks.  For regional anaesthesia, local anaesthetics alone provide good operative conditions but have shorter duration of post-operative analgesia. Hence, various adjuvants such as opioids, clonidine and ketamine are added to local anaesthetics to achieve a quick, dense and prolonged block, but their use is limited by side effects such as nausea, vomiting and pruritis.(9)

 

·      Dexamethasone is highly potent, long-acting glucocorticoid with analgesic, antiemetic, and anti-inflammatory properties, and when used as adjuvant in peripheral nerve blocks, increases the duration of analgesia with minimal side effects and has an added advantage in decreasing postoperative nausea and vomiting (PONV)(10). Dexamethasone when added as anadjuvant to Ropivacaine in ultrasound guided transversus abdominis plane block enhanced the duration of analgesia and decrease total rescue analgesic requirement.

 

 

·      The presence of N-methyl -D -aspartate receptors in skin and muscles have led to the use of Magnesium sulphate.Magnesium helps to regulate the amount of intracellular calcium  and is known to be able to control pain. Magnesium sulphate (MgSO4 ) has analgesic, antihypertensive, anaesthetic sparing effects when used systemically(11,12).ln recent times, MgSO4 has been commonly used as an adjuvant to neuroaxial block, various peripheral nerve blocks as well as plane blocks.

 

·      Thus, this study aims to compare the effects of dexamethasone and Magnesium sulphate as an adjunct to Ropivacaine in Transverse Abdominis Plane (TAP) block as post-operative pain management in patients undergoing Ceserean section.

  

Sample size:

Group RD(n=36) :patients will receive bilateral USG Guided TAP Block with Ropivacaine0.25%  with Dexamethasone (8mg) 20 ml on each side.

Group RM (n=36): patients will receive bilateral USG Guided TAP Block with Ropivacaine0.25% with Magnesium sulfate (250mg) 20ml on each side.

 

Methods:

 

 

After obtaining approval by the institutional human Ethics Committee and CTRI registration, and written informed patient consent, 72 patients under ASA physical status,II,III patients scheduled for caesarean section both emergency and elective, will be included in a prospective, randomized, double-blinded clinical trial at Chettinad Hospital and Research Institute, Kelambakkam, Chennai.

In the preoperative waiting room, detailed history and physical examination will be done. Baseline datas like pulse rate, blood pressure, respiratory rate, and basic investigations will be collected. An  IV access with 18G size IV cannula secured for all patients.

Proper standard monitoring of pulse oximetry, Non invasive blood pressure, continuous electrocardiogram were established and baseline variable values will be noted before the procedure.

Under aseptic precautions,patients will undergo spinal anesthesiain sitting position with hyperbaric Bupivacaine 0.5% (2 ml)with fentanyl 0.5ml at L3-L4 or L4-L5 interstate with 26G or 27 G Quincke needle. Patient’s hemodynamic stability and level of motor and sensory blockade will be assessed and documented. The bilateral TAP block will be performed after skin closure under monitoring with ultrasound guidance ( a high frequency linear probe) with needle in-plane technique , wherein the  23G Quincke’s spinal needle will be inserted between the mid and anterior axillary line extending below the rib line to the highest point of the iliac crest. The needle is placed in between the plane of Internal Oblique muscle and transverse Abdominis muscle, and as per allocation, Group (RD) will receive 20 ml of 0.25%Ropivacaine with Dexamethasone (8mg)on each side and Group (RM) will receive 20 ml of 0.25%Ropivacaine with MgSO4 (1gram)on each side.

During the injection,the distribution of local anesthetics was observed as a hypoechoic enlargement upon USG.

 

After completion of TAP block,hemodynamicstability of the patient assessed and each patient will be moved to the postoperative room for monitoring the vitals and adverse effects.Every patient will be inquired to state the post operative pain by means of VAS scale.Time to preliminary reporting of postoperative pain was noted.

          


 
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