| CTRI Number |
CTRI/2026/02/103585 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study whether Injection Dexamethasone prolongs the duration of spinal anaesthesia and decreases post-operative pain in caesarean section patients |
|
Scientific Title of Study
|
Effect of IV dexamethasone on the duration of spinal anesthesia administered with 0.5% hyperbaric bupivacaine and morphine in elective lower segment caesarean section â Double-blind randomized controlled 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 |
Dr Anusha B |
| Designation |
DNB ANAESTHESIA 1ST YEAR RESIDENT |
| Affiliation |
Mehta Multispeciality Hospital, CHETPET, CHENNAI |
| Address |
Department of Anaesthesia, A block, 1st floor, Operation theatre complex, Mehta Multispeciality Hospitals,
Chetpet, Chennai 600031
Chennai
TAMIL NADU
600031
India |
| Phone |
9597786876 |
| Fax |
|
| Email |
dranushab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prem Kumar M |
| Designation |
HOD ANAESTHESIA DEPARTMENT |
| Affiliation |
Mehta Multispeciality Hospital, CHETPET, CHENNAI |
| Address |
Department of Anaesthesia, A block, 1st floor, Operation theatre complex, Mehta Multispeciality Hospitals,
Chetpet, Chennai-600031
Chennai
TAMIL NADU
600031
India |
| Phone |
9884739206 |
| Fax |
|
| Email |
headanaesthesia@mehtahospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anusha B |
| Designation |
DNB ANAESTHESIA 1ST YEAR RESIDENT |
| Affiliation |
Mehta Multispeciality Hospital, CHETPET, CHENNAI |
| Address |
Department of Anaesthesia, A block, 1st floor, Operation theatre complex, Mehta Multispeciality Hospitals,
Chetpet, Chennai 600031
Chennai
TAMIL NADU
600031
India |
| Phone |
9597786876 |
| Fax |
|
| Email |
dranushab@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, A block, 1st floor, Operation theatre complex, Mehta Multispeciality hospitals, Chet, Chennai - 600031 |
|
|
Primary Sponsor
|
| Name |
Dr. Anusha B |
| Address |
Mehta Multispeciality Hospital, Chetpet, Chennai - 600031. |
| Type of Sponsor |
Other [Self] |
|
|
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 Anusha |
Mehta Multispeciality Hospital |
Department of Anaesthesia, A block, 1st floor, Operation theatre complex, Mehta Multispeciality Hospitals,
Chetpet, Chennai 600031
Mehta Multispeciality Hospitals,
Chetpet, Chennai 600031
Chennai
TAMIL NADU |
9597786876
dranushab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEHTA INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
2 ml of 0.9% normal saline IV immediately after child birth. |
After the pre-anesthetic assessment, patients who are included in the study are randomized into two groups for Spinal anaesthesia in elective LSCS patients. For group B patients, IV 0.9% normal saline 2 ml is given immediately after childbirth. |
| Intervention |
IV Dexamethasone injection 2ml which has 8 mg immediately after child birth |
After the pre-anesthetic assessment, patients who are included in the study are randomized into two groups for Spinal anaesthesia in elective LSCS patients. For group A patients, IV Dexamethasone injection 8 mg which is 2 ml is given immediately after childbirth. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Category : Term Pregnant females
2. Age : 21 - 40 years
3. ASA PS : Grade II
4. Patients undergoing elective LSCS under spinal anaesthesia.
5. Patients who have given valid informed consent.
6. Patients who are able to rate their pain with good GCS and Normal mental status
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patients with severe hypovolemia or hemodynamically unstable
3. Patients with Bleeding Diathesis or coagulation abnormalities
4. Severe pre-eclampsia
5. Eclampsia
6. Gestational diabetes mellitus
7. Ht less than 140cm or more than 180cm
8. BMI more than 30
9. Fetal distress
10. Cord prolapse
11. Infection at the probable site of Spinal anaesthesia
12. Spine deformity
13. Active labour
14. Sepsis
15. Cardiac or neurological disease
16. Failed spinal changed to GA
17. History of Allergy to Dexamethasone |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS SCORE |
immediately post operatively and then at 15 min intervals till 4 hours and at 5, 6, 12, 24 hours post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessing duration of sensory block using pinprick
2. Assessing duration of motor block duration using Modified Bromage Scale grading
3. Hemodynamic parameters |
at 15 min intervals till 4 hours and at 5th and 6th hour post-operatively |
4. Incidence of PONV (post operative nausea and vomiting)
5. Incidence of post-operative shivering
6. Incidence of complications |
Post operatively if present |
| 7.Rescue post-operative analgesia |
Post operatively the first time patient feels pain |
| 8. Total administered analgesics |
At the end of 24 hrs post operatively |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
23/02/2026 |
| 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 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
|
This double blinded randomized control study, led by Dr. Anusha B, aims to evaluate the efficacy of intravenous Dexamethasone in prolonging the duration of postoperative analgesia in elective Lower section Caesarean section under spinal anaesthesia with Inj. 0.5% hyperbaric bupivacaine 2.2 ml and 100 mcg of Inj. Morphine given intrathecally. The primary objective is to assess the effect of single dose IV Dexamethasone 8 mg on prolonging the duration of post-operative analgesia in LSCS under spinal anaesthesia using VAS score immediately on receiving in PACU and then at 15 min intervals till 4 hours and at 5, 6, 12, 24 hours post-operatively. This study enrols 62 pregnant females undergoing elective LSCS under spinal anaesthesia. After thorough preanesthetic check-up of all patients including all routine investigations, written consent shall be obtained. Randomization is done and Group -A will receive Inj. Dexamethasone 8 mg (2 ml) given IV, while Group - B which is the Control group will receive 2 ml 0.9% normal saline IV. Post operatively both groups are compared for Duration of post operative analgesia assessed by Visual Analog Scale score, time required for first rescue analgesic, duration of sensory block, duration of motor block duration using Modified Bromage Scale grading, assessment of Hemodynamic parameters, Total administered analgesics in 24 hrs, Incidence of PONV (post operative nausea and vomiting), Incidence of post operative shivering, Incidence of complications, if present. The statistical analysis will be conducted using SPSS software version 30.0. Statistical tests will be done by independent âtâ-test and chi-square test according to the parameters considering p-value < 0.05 statistically significant. The study is done at Mehta Multi Speciality Hospitals, Chetpet, Chennai. |