| CTRI Number |
CTRI/2024/10/075747 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find which drug will benefit most for pain control in patient undergoing major abdominal cancer surgeries |
|
Scientific Title of Study
|
Comparitive study between dexmedetomidine and fentanyl as adjuvants to continuous ropivacaine epidural infusion for post-operative analgesia in abdominal cancer 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 |
Dr Aparna Sharma |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Medical college, shimla |
| Address |
Department of Anaesthesiology
Indira Gandhi Medical College
Ridge ,sanjauli road Lakkar bazar
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418083224 |
| Fax |
|
| Email |
aparnasharmaraina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Sharma |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Medical college, shimla |
| Address |
Department of Anaesthesiology
Indira Gandhi Medical College
Ridge ,sanjauli road Lakkar bazar
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418083224 |
| Fax |
|
| Email |
aparnasharmaraina@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mathilda Behera |
| Designation |
Junior resident |
| Affiliation |
Indira Gandhi Medical college, shimla |
| Address |
Department of Anaesthesiology
Indira Gandhi Medical College
Ridge ,sanjauli road Lakkar bazar
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7091105511 |
| Fax |
|
| Email |
mathildabehera@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Indra Gandhi Medical College, Ridge, Sanjauli Road, Lakkar Bazar, Shimla, Himachal Pradesh, India 171001 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical college, shimla |
| Address |
Indira Gandhi Medical college, ridge, sanjauli road, lakkar bazar,shimla, himachal pradesh, 171001, India |
| 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 Mathilda Behera |
Indira Gandhi Medical college, shimla, himachal pradesh |
Department of anaesthesia, OT complex 1,2,3,4, Indira Gandhi Medical college, ridge, sanjauli road, shimla, himachal pradesh, india, 171001
Shimla
HIMACHAL PRADESH |
7091105511
mathildabehera@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Indra gandhi medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Thoracic epidural analgesia with Ropivacaine and Dexmedetomedine in major abdominal cancer surgeries |
Comparision between intervention group that is epidural infusion of 0.125% ropivacaine with 0.1 mcg/kg/hr dexmedetomidine at 5ml/hr postoperatively and comparator group that is epidural infusion of 0.125% ropivacaine with 0.1 mcg/kg/hr fentanyl at 5ml/hr postoperatively. Thoracic epidural catheter will be inserted before admininstration of general anaesthesia.Bolus dose of 0.2% ropivacaine with dexmedetomidine 0.1 mcg/ ml according to the number of segments will be given before skin incision.After extubation an infusion of dexmedetomidine 0.1mcg/ kg/ hr with 0.125%ropivacaine will be started and continued for 48 hours postoperatively. |
| Comparator Agent |
Thoracic epidural analgesia with Ropivacaine and Fentanyl in major abdominal cancer surgeries |
Thoracic epidural catheter will be inserted before admininstration of general anaesthesia.Bolus dose of 0.2% ropivacaine with Fentanyl 0.1 mcg/ ml according to the number of segments will be given before skin incision.After extubation an infusion of Fentanyl 0.1mcg/ kg/ hr with 0.125%ropivacaine will be started and continued for 48 hours postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient scheduled for major abdominal cancer surgeries
2. ASA grade I-III women
3. Age group 18 -70 years
4. BMI ≤ 35 |
|
| ExclusionCriteria |
| Details |
1. Infection at epidural site
2. History of coagulopathy
3. Severely hypovolemic patients
4. Raised ICP
5. Sepsis
6. Refusal for epidural analgesia
7. Pre-existing neurological deficit or demyelinating disorders
8. Severe spinal deformity
9. Known allergy to local anaesthetics or fentanyl or dexmedetomedine
10. Chronic pain or long term opiods or NSAIDS usage
11. Those who have coexisting cardio-respiratory disease e.g. ventricular
dysfunction or history of AV Block /bradyarrythmias
12. Catheter removal unintentionally
13. Asymmetric or unilateral block requiring catheter manipulation
14. Patient not extubated and transferred to ICU
15. Surgery with blood loss more than 30%
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the efficacy and duration of post operative epidural analgesia
between the two groups using VAS score at rest and movement
2. To compare cumulative consumption of rescue analgesia between the two groups |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare time to first rescue analgesia requirement between the two groups |
48 hours |
To compare incidence of such as bradycardia, hypotension and sedation,
post-operative ileus and nausea & vomiting between two groups |
48 hours |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/11/2024 |
| 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
|
Although the limited data available suggests that dexmedetomedine as an adjuvant to continuous epidural infusion of ropivacaine has superior results in post-operative analgesia and less side-effects as compared to fentanyl. To establish this efficacy further validation and research is required. Therefore, we planned a study to determine the efficacy of both the adjuvants and compare post-operative analgesia and rescue requirement and also, dose reduction in requirement of local anaesthetic after the addition of adjuvant. |