FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/11/059419 [Registered on: 02/11/2023] Trial Registered Prospectively
Last Modified On: 01/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare changes in blood sugar levels after addition of 2 different doses of dexamethasone to local anaesthetic for pain relief in patients undergoing caesarean section surgeries 
Scientific Title of Study   The effect of two different doses of dexamethasone on blood sugar levels when added as an additive to local anaesthetic in transversalis fascia plane block in caesarean section surgeries - an observational 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  Kakani Vishnu Vandana 
Designation  Postgraduate 
Affiliation  Narayana medical college and hospital 
Address  2nd floor, Department of Anaesthesiology, General hospital, Narayana Medical College and Hospital , Chinthareddypalem, Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  9492923382  
Fax    
Email  vish4ms@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajitha A 
Designation  Assistant professor 
Affiliation  Narayana medical college and hospital 
Address  2nd floor, department of anaesthesiology, general hospital, narayana medical college and hospital , chinthareddypalem, nellore


ANDHRA PRADESH
524003
India 
Phone  9491847821  
Fax    
Email  rajithaanga@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kakani Vishnu Vandana 
Designation  Postgraduate 
Affiliation  Narayana medical college and hospital 
Address  2nd floor, department of anaesthesiology, general hospital, narayana medical college and hospital , chinthareddypalem, nellore


ANDHRA PRADESH
524003
India 
Phone  9492923382  
Fax    
Email  vish4ms@gmail.com  
 
Source of Monetary or Material Support  
Narayana Medical College and Hospital, Chinthareddypalem, Nellore, 524003 
 
Primary Sponsor  
Name  Narayana Medical College and Hospital 
Address  Narayana Medical College and Hospital, Chinthareddypalem, Nellore,524003 
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 Kakani Vishnu Vandana  Narayana Medical College and Hospital  2nd floor, Department of Anaesthesiology, General hospital,Narayana Medical College and Hospital, Chinthareddypalem, Nellore - 524003
Nellore
ANDHRA PRADESH 
9492923382

vish4ms@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Effect on 4mg dexamethasone on blood sugars and surgical site infection when used as adjuvant in transversalis fascia plane block  transversalis fascia plane block is given with 0.125% levobupivacaine and 4mg dexamethasone and 2nd hour postoperative blood sugars and fasting blood sugars on postoperative day 1,2,3 and surgical site infection after 1 month will be studied  
Comparator Agent  Effect on 8mg dexamethasone on blood sugars and surgical site infection when used as adjuvant in transversalis fascia plane block  Transversalis fascia plane block is given with 0.125% levobupivacaine and 8mg dexamethasone and 2nd hour postoperative blood sugars and fasting blood sugars on postoperative day 1,2,3 and surgical site infection after 1 month will be studied 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1)Weight 40-70 kg, BMI<35kg/m2.
2)Patient aged between 20- 40years.
3)ASA II listed for elective Caesarean section
 
 
ExclusionCriteria 
Details  1) Patients without valid informed and written risk consent
2) ASA III and IV
3) Patients with BMI>35kg/m2.
4) Use of oral anticoagulants
5) Allergy to study drugs
•Local infection
•Severe psychiatric disorders
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of 4mg dexamethasone and 8mg dexamethasone added to levobupivacaine on postoperative blood sugars  2hours postoperatively and fasting blood sugars on postoperative day 1,2 and 3 
 
Secondary Outcome  
Outcome  TimePoints 
To assess VAS Scores in both the groups   immediately,6hr,12hr,24 hrs 
To assess the occurrence of surgical site infection in both the groups  30 days 
 
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 1 
Date of First Enrollment (India)   09/11/2023 
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="0"
Months="6"
Days="0" 
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  

Adequate post-operative analgesia after caesarean section (CS) is vital as it impacts the recovery of the parturient. Ultrasound guided fascia plane blocks are being given post surgery to alleviate pain and decrease the consumption of opioids. One such novel technique is the transversalis fascia plane block. The transversalis fascia plane (TFP) block is an ultrasound-guided regional anesthetic technique that targets the T12 and L1 spinal nerves by injecting local anesthesia between the posterior aponeurotic extension of the transversus abdominis muscle and the deep investing transversalis fascia which provides postoperative analgesia for parturients undergoing Caesarean section.  Dexamethasone is often added as an additive to prolong the duration of action of local anaesthetic but steroids are known to increase blood glucose levels above the physiological levels. In this study we are going to monitor the effect of addition of 2 different concentrations of dexamethasone on post operative blood sugars, surgical site infection and postoperative analgesia.

 
Close