| CTRI Number |
CTRI/2024/01/061835 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study the effect of fentanyl and buprenorphine in spinal anesthesia to decrease the post-operative pain in patients undergoing lower abdominal surgeries.
|
|
Scientific Title of Study
|
Comparative Study Of The Analgesic Effect Of Fentanyl And Buprenorphine As Spinal Adjuvants In Adult Patients Undergoing Infraumbilical Surgeries :A Randomized Double- Blind Controlled 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 |
Dr.Vaishali Sarote |
| Designation |
PG Student |
| Affiliation |
Mahatma Gandhi Institute Of Medical Science Sewagram SEWAGRAM |
| Address |
Department Of Anesthesiology.
Mahatma Gandhi Institute Of medical Science Sewagram Wardha
Sewagram Wardha Maharashtra.
Wardha
MAHARASHTRA
442102
India |
| Phone |
8530068494 |
| Fax |
07152-284333 |
| Email |
vaishalisarote@mgims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sucheta Tidke |
| Designation |
Professor and Head Of The Department |
| Affiliation |
Mahatma Gandhi Institute Of Medical Science |
| Address |
Department Of Anesthesiology.
Mahatma Gandhi Institute Of Medical Science Sewagram Wardha.
Sewagram Wardha Maharashtra.
Wardha
MAHARASHTRA
442102
India |
| Phone |
9850510019 |
| Fax |
07152-284333 |
| Email |
suchetatidke@mgims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Vaishali Sarote |
| Designation |
PG Student |
| Affiliation |
Mahatma Gandhi Institute Of Medical Science |
| Address |
Department Of Anesthesiology.
Mahatma Gandhi Institute Of medical Science Sewagram Wardha
Sewagram Wardha Maharashtra.
Wardha
MAHARASHTRA
442102
India |
| Phone |
8530068494 |
| Fax |
07152-284333 |
| Email |
vaishalisarote@mgims.ac.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Institute Of Medical Science-Sevagram |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Institute Of Medical Science |
| Address |
SEWAGRAM, WARDHA |
| Type of Sponsor |
Government 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 Vaishali Sarote |
Mahatma Gandhi Institute Of Medical Science |
Department Of Anesthesiology.
Frist floor Main OT Complex Area
Sewagram.
Wardha
MAHARASHTRA |
8530068494
vaishalisarote@mgims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K421||Umbilical hernia with gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Buprenorphine |
inj.buprenorphine 60mcg with inj.bupivacaine (0.5%) 3ml for 24 hours. |
| Intervention |
FENTANYL |
inj.fentanyl 25mcg with inj.Bupivacaine (0.5%) 3ml for 24 hours
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologist Grade I and II patients.
Age 18-65 years of either gender.
Patients undergoing infraumbilical Surgeries.
Height is more than 4 feet.
Patients willing to give consent.
|
|
| ExclusionCriteria |
| Details |
American Society of Anesthesiologists Grade III and IV patients.
Patients with known contraindications for spinal anesthesia: bleeding disorders, local infection.
Patients with cardiovascular instability.
Patients with comorbidities like Hypertension, Diabetes Mellitus, cardiac diseases, etc.
Patient with allergy to opioids or history of hypersensitivity to local anesthetics.
Emergency surgeries.
Patients with a history of severe PDPH or PONV after spinal anesthesia.
Patients not willing to give informed written consent.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the duration of sensory & motor blockade. |
15min 30min 45min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The onset of sensory & motor blocks was achieved.
2.The level of blockade achieved.
3. The efficacy of postoperative analgesia.
4. Side effects like hemodynamic changes (hypotension and bradycardia) sedation, pruritus, post-operative nausea and vomiting and respiratory depression.
|
15min, 30min,45min |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 4 |
|
Date of First Enrollment (India)
|
30/01/2024 |
| 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="2"
Months="0"
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
|
Spinal anesthesia is the most common approach for anesthesia used for lower abdominal surgery. Adjuvants are often used with local anesthetics for synergistic effects by prolonging duration of block dose requirement. Drugs like morphine, tramadol, fentanyl are being used in practice. Currently research has to be done for local anesthetics which have long duration of action with less potential side effects. There have been many studies done for adjuvants in spinal anesthesia but no specified result available for maximum benefits and minimum side effect. The data remains inconclusive. This study evaluate the onset ,duration of sensory and motor block, hemodynamic effects, post-operative analgesia and adverse effect of Buprenorphine and Fentanyl given intrathecally with 0.5 % hyperbaric Bupivacaine. There is paucity of literature especially from Indian scenarios for the current topic and therefore the need for research study on this topic.
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