| CTRI Number |
CTRI/2024/06/069447 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
To compare drugs having more pain relieving action by adding them to primary drug and giving via abdominal block in patients undergoing lower abdominal surgeries |
|
Scientific Title of Study
|
A comparative study of Magnesium Sulphate versus Dexamethasone as an adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block in patients undergoing lower abdominal surgeries |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jekha Mary Babu |
| Designation |
Junior Resident, Department of Anaesthesiology |
| Affiliation |
Dr. D. Y. Patil Medical College, Hospital and Research Centre |
| Address |
Dr. D. Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri-Chinchwad, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9995709800 |
| Fax |
|
| Email |
jekha1411@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhaya M Suryawanshi |
| Designation |
HOD and Professor, Department of Anaesthesiology |
| Affiliation |
Dr. D. Y. Patil Medical College, Hospital and Research Centre |
| Address |
Dr. D. Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri-Chinchwad, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chhaya M Suryawanshi |
| Designation |
HOD and Professor, Department of Anaesthesiology |
| Affiliation |
Dr. D. Y. Patil Medical College, Hospital and Research Centre |
| Address |
Dr. D. Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri-Chinchwad, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri-Chinchwad, Pune |
|
|
Primary Sponsor
|
| Name |
Jekha Mary Babu |
| Address |
Dr. D. Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri-Chinchwad, Pune, Maharashtra 411018 |
| 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 Chhaya Suryawanshi |
Dr. D. Y. Patil Medical College, Hospital and Research Centre |
Dr. D. Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri-Chinchwad, Pune, Maharashtra 411018
Pune
MAHARASHTRA |
9922888201
chhayasuryawanshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-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, (2) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A comparative study of magnesium sulphate versus dexamethasone as an adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block in patient undergoing lower abdominal surgeries lasting 1-3 hours |
Comparing transversus abdominis plane block given with 18 ml of 0.25% bupivacaine hydrochloride plus 2 ml (200 mg) of magnesium sulphate versus 18 ml of 0.25% bupivacaine hydrocholoride plus 2 ml (8 mg) of dexamethasone under ultrasound guidance for post operative pain management in lower abdominal surgeries lasting 1-3 hours |
| Comparator Agent |
A comparative study of magnesium sulphate versus dexamethasone as an adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block in patient undergoing lower abdominal surgeries lasting 1-3 hours |
Comparing transversus abdominis plane block given with 18 ml of 0.25% bupivacaine hydrochloride plus 2 ml (200 mg) of magnesium sulphate versus 18 ml of 0.25% bupivacaine hydrocholoride plus 2 ml (8 mg) of dexamethasone under ultrasound guidance for post operative pain management in lower abdominal surgeries lasting 1-3 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA grade I or II fit patients, 2)Ages between 18 and 65 years, 3) Patients undergoing lower abdominal surgeries under spinal anaesthesia, 4) Hemodynamically stable patients with all routine investigations within normal limits without any other co-morbidities, 5)Patients who are not on any cardiac related drugs, 6) Availability of written informed consent from concerned patient.
|
|
| ExclusionCriteria |
| Details |
1)Patients not willing to participate in this study, 2)Patients with ASA physical status III and above physical status, 3)Patients less than 18 years and above 65 years of age, 4)Patients with uncontrolled systemic disorders like neurological, cardiac, metabolic, renal, pulmonary disorders, hepatic disease with coagulation abnormalities etc, 5)Patients on calcium channel blocker, 6)Patients having local infection at the site where needle for block was to be inserted, 7)Patients with contraindication for spinal anaesthesia, 8)Patients with bleeding or coagulation disorders, 9)Patients with known allergies to the study drugs, 10)Patients with weight less than 40 kgs and height less than 140 cms
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A comparative study of magnesium sulphate versus dexamethasone as an adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block in patient undergoing lower abdominal surgeries |
After administration of the block, pain scores will be assessed in both the groups in less than 5 minutes after giving block, after 2 hours, after 4 hours, after 6 hours, after 12 hours, after 16 hours, after 20 hours, and after 24 hours will be assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A comparative study of magnesium sulphate & dexamethasone as an adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block in patient undergoing lower abdominal surgeries |
Duration of analgesia will be assessed post giving block after surgery & time to rescue analgesia will be assessed |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/07/2024 |
| 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="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
|
It is a prospective, comparative, randomized, double blinded study to compare magnesium sulphate versus dexamethasone as an adjuvant to 0.25% bupivacaine in ultrasound-guided transversus abdominis plane block in patients undergoing lower abdominal surgeries. the parameters that will be assessed include quality of block, duration of block, timely post operative pain scores, time to rescue analgesia and total number of analgesics given in 24 hours |