| CTRI Number |
CTRI/2025/11/097137 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
08/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of Intravenous versus Perineural Dexamethasone as an Adjuvant to Bupivacaine in Transversus Abdominis Plane Block for Postoperative Analgesia in Cesarean Section” |
|
Scientific Title of Study
|
Comparative Study of Intravenous Versus Perineural Dexamethasone Added To TAP Block For Analgesia After Cesarean Section. |
| 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 Anagha J |
| Designation |
Junior resident |
| Affiliation |
Saptagiri institute of medical Sciences |
| Address |
Department of anesthesia,ground floor, Saptagiri institute of medical Sciences,navya layout, hesarghatta road,bengaluru
Bangalore
KARNATAKA
560090
India |
| Phone |
9483743500 |
| Fax |
|
| Email |
anaghaj16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth prabhu j |
| Designation |
Professor |
| Affiliation |
Saptagiri institute of medical Sciences |
| Address |
Department of anesthesia ground floor, Saptagiri institute of medical Sciences, Bengaluru
Bangalore
KARNATAKA
560090
India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth prabhu j |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of medical Sciences |
| Address |
Department of anesthesia ground floor Saptagiri institute of medical Sciences navya layout hesarghatta road bengaluru
Bangalore
KARNATAKA
560090
India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute of medical Sciences |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute of medical Sciences |
| Address |
Department of anesthesia ground floor Saptagiri institute of medical Sciences navya layout hesarghatta road bengaluru |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Anagha j |
Sapthagiri institute of medical sciences and research institute |
Department of anesthesia ground floor Saptagiri institute of medical Sciences navya layout hesarghatta road bengaluru
Bangalore
KARNATAKA |
09483743500
anaghaj16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saptagiri institute of medical Sciences |
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, (2) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous dexamethasone with TAP block. |
6mg intravenous dexamethasone with TAP block for analgesia after cesarean section. |
| Intervention |
Ultrasound guided Perineural dexamethasone with TAP block |
Ultrasound guided 6mg perineural dexamethasone with TAP block for analgesia after cesarean section |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with an American Society of Anesthesiologists (ASA) score of I,II,III who were scheduled for cesarean section under spinal anesthesia were included in the study |
|
| ExclusionCriteria |
| Details |
1.Refusal to participate in the study Known allergies to local anesthetics or opioids or nonsteroidal anti-inflammatory drugs 2.Presence of infection at the needle entry site for the block 3. Use of chronic pain medications 4. Platelet count of less than 50000 cells per mm |
|
|
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 |
| We hypothesise that the duration of analgesia with perineural dexamethasone 6mg is greater than intravenous 6mg dexamethasone |
15min,30min,1hour, 2hour, 4hours 6hours 12hours, 24hrs, |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="4"
Days="1" |
|
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
|
Cesarean section (CS) is commonly performed lifesaving surgical procedure to reduce fetal and maternal mortality and morbidity rates . The use of regional anesthesia, including spinal or another type of peripheral block, may prevent the pain that has moderate-to-severe intensity in the first 24 h after CS operations.The postoperative moderate-to-severe pain incidence rate after CS under spinal anesthesia accounts for 77.4% of the cases. The worst pain intensity was reported at 6 h CS operation .For these operations, adequate postoperative pain relief is crucial to facilitate early ambulation, providing good infant care (including breastfeeding, maternal-infant bonding), and preventing postoperative morbidity. If acute postoperative pain after CS is inadequately treated, there is an increased incidence of chronic pain by 10– 15% and some reports of post-traumatic stress syndrome.(1) Transversus abdominis plane block is known to provide effective postopertive analgesia in patients undergoing LSCS. Bupivacaine is one of the widely used local analgesics . Dexamethasone, a corticosteroid, provide analgesia owing to its anti-inflammatory properties. It also potentiates the effect of local anesthetics . In light of this knowledge, dexamethasone has been used as an adjuvant in various studies to improve the anesthetic effects of TAP block post LSCS operations .(2) Both perineural and intravenous (IV) dexamethasone aim to prolong the duration of analgesia (pain relief) in peripheral nerve blocks when used along with local anaesthetics. While perineural administration involves injecting dexamethasone near the nerve, IV administration delivers it systemically, and both methods are thought to reduce inflammation and potentially improve pain management.(5) Hence we plan to study the effect of perineural and intravenous dexamethasone with 30ml of 0.2% bupivacaine for bilateral transverse abdominal plane block for postoperative analgesia in LSCS surgeries. |