| 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
|
|
|
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
|
|
|
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. |