| CTRI Number |
CTRI/2023/06/053538 [Registered on: 05/06/2023] Trial Registered Prospectively |
| Last Modified On: |
01/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Post operative Pain Management -A comparative study of two different doses of Dexmedetomedine as an adjuvant to Bupivacaine in epidural infusion. |
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Scientific Title of Study
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A comparative study of post operative pain relief by continuous epidural infusion of Bupivacaine with two different doses of Dexmedetomedine as an adjuvant
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| Trial Acronym |
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|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANAND CHAKRADHAR PULIGADDA |
| Designation |
JUNIOR RESIDENT PG |
| Affiliation |
ACS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPT OF ANAESTHESIOLOGY,ACS MEDICAL COLLEGE AND HOSPITAL.PONNAMALLE HIGH ROAD, VELAPPANCHAVIDI,CHENNAI 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
8008789830 |
| Fax |
|
| Email |
dr.puligadda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAMA |
| Designation |
PROFESSOR |
| Affiliation |
ACS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPT OF ANAESTHESIOLOGY,ACS MEDICAL COLLEGE AND HOSPITAL.PONNAMALLE HIGH ROAD, VELAPPANCHAVIDI,CHENNAI 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9566823041 |
| Fax |
|
| Email |
drrama87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAMA |
| Designation |
PROFESSOR |
| Affiliation |
ACS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPT OF ANAESTHESIOLOGY,ACS MEDICAL COLLEGE AND HOSPITAL.PONNAMALLE HIGH ROAD, VELAPPANCHAVIDI,CHENNAI 600077
TAMIL NADU
600077
India |
| Phone |
9566823041 |
| Fax |
|
| Email |
drrama87@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACS MEDICAL COLLEGE AND HOSPITAL,PONNAMALLE HIGH ROAD,VELAPPANCHAVIDI,CHENNAI.600077 |
|
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Primary Sponsor
|
| Name |
ACS MEDICAL COLLEGE AND HOSPITAL |
| Address |
PONNAMALLE HIGH ROAD, VELAPPANCHAVIDI,CHENNAI 600077 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ANAND CHAKRADHAR PULIGADDA |
ACS MEDICAL COLLEGE AND HOSPITAL |
POST OP ICU,BASEMENT OT,DEPT OF ANAESTHESIOLOGY,ACS MEDICAL COLLEGE AND HOSPITAL,PONNAMALLE HIGH ROAD, VELAPPANCHAVIDI,CHENNAI 600077
Chennai
TAMIL NADU |
8008789830
DR.PULIGADDA@GMAIL.COM |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTE |
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: 4||Measurement and Monitoring, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BUPIVACAINE |
EPIDURAL INFUSION OF 0.125%/CC BUPIVACAINE FOR 24 HRS POST OP PERIOD. |
| Comparator Agent |
DEXMEDETOMEDINE |
AS EPIDURAL INDUSION 2MCG/KG ALONG WITH 0.125%/CC BUPIVACAINE FOR 24HRS POST OPERATIVE PERIOD. |
| Comparator Agent |
DEXMEDETOMEDINE |
AS EPIDURAL INFUSION 1MCG /KG ALONG WITH 0.125%/CC BUPIVACAINE FOR 24HRS POST OPERATIVE PERIOD |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ALL PATIENTS WILLING FOR STUDY.
PATIENTS WITH BOTH GENDERS
PATIENTS WHO ARE CONSIOUS AND ORIENTED
ALL PATIENTS UNDERGOING SURGERIES BELOW LEVEL OF UMBILICUS
ALL PATIENTS UNDER ASA 1, ASA 2, ASA 3 CATEGORIES,
ALL PATIENTS UNDERGOING SURGERIES WITH SOLO EPIDURAL PROCEDURE, EPIDURAL WITH SPINAL WITH SPINAL DRUG WITH NO ADJUVANTS ,
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| ExclusionCriteria |
| Details |
PATIENTS WHO REFUSE FOR PROSEDURE
PREGNANT PATIENTS
PATIENTS WITH SPINAL BIRTH DEFECTS,HEMATOLOGICAL CONDITIONS ,HEMOSTATIC DISORDERS
OBESE PATIENTS
PATIENTS WITH CHRONIC BACK PAIN
PSYCHIATRIC PATIENTS
UNCONSIOUS,NOT ORIENTED,COMATOSED PATIENTS.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) HAEMODYNAMIC AND RESPIRATORY PARAMETERS ( BP,PULSE,SPO2,MAP)
2) VISUAL ANALOGUE PAIN SCORE MONITORING DURING PROCEDURE
(VAS SCORE 1 TO 10) |
1.at beginning of epidural infusion
2.at 5 min after first dose
3.at 10 min after beginning infusion
4.at 20 min after beginning of infusion
5.at 1hr after beginning of infusion
6.at 6hrs after beginning of infusion
7.at 12 hrs after beginning of infusion
8.at 24hrs after beginning of infusion |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1) DOSE OF DRUG AT WHICH PATIENT GETS MAXIMUM PAIN RELIEF. |
DURING THE PROCEDURE |
|
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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 |
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Date of First Enrollment (India)
|
12/06/2023 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
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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
|
AIM and OBJECTIVES
To compare 0.125% bupivacaine with two different doses of dexmedetomidine (1mcg/kg and 2mcg /kg )as adjuvant for epidural analgesia in surgeries below level of umbilicus ,post operative onset, quality and duration of analgesia, blood pressure, pulse rate, outcome.
MATERIALS AND METHODS
STUDY SITE : ACS MEDICAL COLLEGE AND HOSPITALS, DEPARTMENT ANAESTHESIA
STUDY DESIGN : PROSPECTIVE,RANDOM DOUBLE BLIND HOSPITAL BASED STUDY.
STUDY DURATION: 2 YEARS
MINIMUM SAMPLE SIZE: MINIMUM SAMPLE SIZE IS 100 PATIENTS.
As valuable adjuncts to local anesthetics, ά-2 agonists have sedative properties and analgesic actions at peripheral, spinal and supra spinal levels. Dexmedetomidine - a highly selective ά-2 agonist has been demonstrated to have a strong synergistic action with local anesthetics. Furthermore, when used through the epidural route, Dexmedetomidine has been shown to have numerous beneficial effects.
It acts on both pre and post synaptic sympathetic nerve terminals and on the central nervous system, decreasing sympathetic outflow and norepinephrine release, with consequent sedative, anti-anxiety, analgesic, sympatholytic effects.
Dexmedetomidine causes dose dependent bradycardia, hypotension, so, in this prospective study we have used two different doses that are, 1 and 2 μg/kg along with the local anesthetic agent bupivacaine to compare their analgesic and anesthetic efficacy as well as their side effects. All patients will be anesthetized via epidural route in a double blinded fashion based on a computer generated code to one of the following three treatment groups to receive either
Group 1 :12.5ml bupivacaine (ANAWIN 0.5%) (n=20) (control group)
Group 2 :12.5ml bupivacaine (ANAWIN0.5%) plus 1 μgkg-1 5dexmedetomidine (50μg/ml concentration)(n=20)] Group 3 : 12.5 ml bupivacaine (ANAWIN 0.5%)plus 2 μg/kg dexmedetomidine { 100mcg/ml concentration)(n=20)].
The anesthetic solution was completed to 50ml using normal saline.
The anesthetic dose will be given in infusion form using infusion pump at infusion rate of 5ml/hr for a period of 24hrs.
Parameters recorded and assessed
onset of analgesia, duration of the epidural analgesia , Mean Arterial Pressure(MAP), Heart rate, Visual Analogue Pain Scale(VAS)
Tools used
VAS PAIN SCORE:
VISUAL ANALOGUE SCALE Used to assess the severity of pain. 0- No pain 1- 2- Mild pain 3- 4- Moderate pain 5- 6- Severe pain 7- 8- Very severe pain 9- 10- Worst possible pain
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