| CTRI Number |
CTRI/2024/04/065125 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of intravenous steroid
vs perineural steroids as an additive in abdominal plane blocks in patient undergoing cesarian section - A Clinical trail |
|
Scientific Title of Study
|
Efficacy of intravenous versus perineal dexamethasone as an adjuvant in transverse abdominis plane block for post operative analgesia following elective cesarean section - A randomised double blinded clinical 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 |
Nithin K |
| Designation |
Post graduate student |
| Affiliation |
Sri Balaji vidyapeeth |
| Address |
211, department of anaesthesiology,
Mahatma Gandhi medical college and research institute,
Pillaiyarkuppam,
Pondicherry
Pondicherry PONDICHERRY 607402 India |
| Phone |
8489332550 |
| Fax |
|
| Email |
nithin.nash15@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Gayatri mishra |
| Designation |
Professor |
| Affiliation |
Sri Balaji vidyapeeth |
| Address |
211, department of anaesthesiology,
Mahatma Gandhi medical college and research institute
Pillaiyarkuppam,
Pondicherry
Pondicherry PONDICHERRY 607402 India |
| Phone |
8489332550 |
| Fax |
|
| Email |
drgayatrimishra@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nithin K |
| Designation |
Post graduate student |
| Affiliation |
Sri Balaji vidyapeeth |
| Address |
211, department of anaesthesiology,
Mahatma Gandhi medical college and research institute,
Pillaiyarkuppam,
Pondicherry
Pondicherry PONDICHERRY 607402 India |
| Phone |
8489332550 |
| Fax |
|
| Email |
nithin.nash15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi medical college hospital and research institute , pillayarkuppam, puducherry, India 607402 |
|
|
Primary Sponsor
|
| Name |
Nithin K |
| Address |
Mahatma Gandhi medical college and research institute
Periyakattupalayam,
Pondicherry.
607402 |
| 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 |
| Nithin K |
Mahatma Gandhi medical college and research institute |
Department of anaesthesiology Pondicherry PONDICHERRY |
8489332550
nithin.nash15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O759||Complication of labor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous dexamethasone |
Inj.Dexamethasone of 8mg (2ml) will be given along with bilateral TAP block via interavenous route, the drug will be administered only once |
| Comparator Agent |
Perineural dexamethasone |
Inj.dexamethasone of 8mg (1ml on each side) will be added with the local anaesthetic given along with the bilateral TAP block. The drug will be administered once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.All pregnant women
2.ASA II patients
|
|
| ExclusionCriteria |
| Details |
1.Allergy to local anaesthetic drugs
2.Seizure disorders
3.Any intraoperative surgical complications
4.Prolonged duration of labour
5.If caesarean section is done under general anaesthesia
6.Dexamethasone Used During Intra Operative period
7.Patients having gestational diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the duration of analgesia. |
At baseline, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess & compare the static & dynamic post-op pain scores at 0, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours using visual analog scale.
|
Baseline, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours |
| To assess & compare the loss of sensation to cold & touch in the abdominal wall dermatomes from T9 to L1, in the midline & midclavicular lines on both sides. |
Baseline, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours |
| To assess & compare the time to first analgesic requirement. |
8 hours & 12 hours |
| To measure the 24-hour cumulative rescue analgesic consumption. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| 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="0" 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
|
Cesarean delivery (CD) is one of the most commonly performed lower abdominal surgeries. CD pain has both a somatic component due to the surgical incision and a visceral component due to uterine contractions. Blocking both components leads to decreased maternal morbidity, early mobilization,and increased patient satisfaction. The infra-umbilical portion of the anterior abdominal wall is supplied by T7-L1 nerves, which travel in the plane between the transverse abdominus muscle and the internal oblique muscle- the transversus abdominis plane (TAP).The nerves in addition give out a lateral cutaneous branch, which arises proximal to the angle of the rib, runs a short distance with the main nerve, and emerges obliquely through the overlying muscles in the mid axillary line to supply the respective dermatomes. The transverse abdominal plane (TAP) block, is used to block these nerves and their branches in the TAP. Dexamethasone is a synthetic glucocorticoid with anti-inflammatory and immunosuppressive properties. With 20 to 30 times the binding affinity for glucocorticoid receptors of endogenous cortisol, which causes vasoconstriction and reduce absorption of administered local anesthetic, decreases the inflammatory response and blocking k + channel used for pain transmission and transduction. Various studies have been done in dexamethasone for prevention of post-operative nausea and vomiting (PONV) in caesarean section.Even though dexamethasone is one of the most commonly used antiemetics, its mechanism of action remains unclear. Post-operative pain relief using dexamethasone as an adjuvant in perineural TAP block has been studied in caesarean sections. IV dexamethasone has been studied for post-operative pain management in patients undergoing caesarean section.Various studies have been done comparing IV dexamethasone and perineural dexamethasone for post-operative pain relief in peripheral nerve block, supraclavicular block, interscalene block. A literature search revealed that there is only one study related to comparing IV dexamethasone and dexamethasone as adjuvant in the TAP block in elective LSCS and that was done without using ultrasound guidance. There is lack of study using ultrasound guided TAP block, Hence this study is being done to compare the ultrasound guided TAP block using dexamethasone as an adjuvant to 0.25% bupivacaine and IV dexamethasone for post-operative analgesia following elective caesarean section |