| CTRI Number |
CTRI/2021/09/036936 [Registered on: 28/09/2021] Trial Registered Prospectively |
| Last Modified On: |
27/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effects of two different drugs (Morphine and Dexmedetomidine) given as spinal anaesthesia to reduce post-operative pain in liver and pancreas surgeries |
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Scientific Title of Study
|
Comparison of intrathecal morphine versus dexmedetomidine for postoperative analgesia in hepatopancreatic surgeries: A prospective double blinded randomized interventional clinical trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Andrea Grace Oommen |
| Designation |
Anaesthesia PG |
| Affiliation |
CMC Vellore |
| Address |
Batch of 2020,Department of Anaesthesia,CMC Vellore
House no 5A,Kuttiyil Spring field,Residency Nagar,Kollam-1.Kerala.
Vellore
TAMIL NADU
632004
India |
| Phone |
8825816947 |
| Fax |
|
| Email |
andreaoommen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tony Thomson Chandy |
| Designation |
Professor and HOU |
| Affiliation |
CMC Vellore |
| Address |
Anaesthesia Unit 1
Department of Anaesthesia,
Christian Medical College, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
95002424 |
| Fax |
|
| Email |
tonythomson@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Andrea Grace Oommen |
| Designation |
Anaesthesia PG |
| Affiliation |
CMC Vellore |
| Address |
Batch of 2020,Department of anaesthesia,CMC vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
8825816947 |
| Fax |
|
| Email |
andreaoommen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Internal - Fluid Research Grant (Rs. 1,50,000/- Per Year).CMC Vellore. |
|
|
Primary Sponsor
|
| Name |
CMC vellore |
| Address |
CMC vellore |
| Type of Sponsor |
Other [internal fluid research grant] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Andrea Grace Oommen |
CMC Vellore |
Department of Anaesgthesia
DEpartment OF Hepatopancreaticbiliary Surgery.
Vellore
TAMIL NADU |
8825816947
andreaoommen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB CMC Vellore |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: K769||Liver disease, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Morphine |
Intrathecal morphine 4mcg/kg |
| Comparator Agent |
Dexmedetomidine |
Intrathecal Dexmedetomidine 20mcg |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing hepatopancreatic surgeries
2. ASA I and II
3. Age >18years
|
|
| ExclusionCriteria |
| Details |
1. Patient Refusal
2. ASA III and IV
3. Contraindications to spinal Anaesthesia
4. Patients on Beta blockers
5. Known allergy to study drugs.
|
|
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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 and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain score assessment using Numerical Rating Scale (NRS) |
Postoperative pain score assessment using Numerical Rating Scale (NRS) baseline and every Q6h for 48 hours |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Intraoperative hemodynamics
2. Time to awaken
3. Postoperative sedation scores
4. Time to rescue analgesia
5. Time to mobilization
|
1. Intraoperative hemodynamics baseline,post intrathecal drug,post induction,5 min,30 min,and Q1hrly till end of surgery
2. Time to awaken
3. Postoperative sedation scores Q1hrly for 3 hours and at discharge from recovery.
4. Time to rescue analgesia in 48 hours post surgery
5. Time to mobilization
in 48 hours post surgery |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/10/2021 |
| 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
|
nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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|
Brief Summary
|
Adequate analgesia provided in upper abdominal
surgeries helps to enhance recovery, decrease post-operative morbidity and decrease
the length of hospital stay. The standard of care in managing post- operative
pain in upper abdominal surgeries has the been the use of thoracic epidural analgesia.
However, an increased risk of postoperative coagulopathy after hepatectomies,
prolonged immobilization, urinary retention, hypotension, and an increased
chance of anastomotic leak with thoracic epidural analgesia in the post-operative
period has made it less favorable. Intrathecal morphine has proved an alternative to
epidural analgesia providing effective postoperative analgesia with
significantly lower adverse effects and risks and shown a reduced requirement
for intravenous opioids. Intrathecal morphine has a proven worth in
hepatobiliary surgery. However, there is an added risk of respiratory depression.
Dexmedetomidine, a specific and selective alpha-2 adrenoreceptor
agonist produces dose dependent anxiolysis, sedation and longer duration of
analgesia with no respiratory depression. Intrathecal dexmedetomidine has been
studied in lower abdominal and lower limb surgeries where it prolongs the
action of bupivacaine and has extended postoperative analgesia.
Our study intends to compare postoperative analgesia
in hepato-pancreatic surgeries where there is still a paucity of sufficient
data.
The use of intrathecal dexmedetomidine could emerge
as a promising alternative to epidural analgesia in the future for better
patient outcome among hepatic and pancreatic surgeries.
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