| CTRI Number |
CTRI/2020/05/025021 [Registered on: 05/05/2020] Trial Registered Prospectively |
| Last Modified On: |
18/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of a drug on pain management given with regional block to reduce pain after surgery |
|
Scientific Title of Study
|
comparative evaluation of ropivacaine and ropivacaine with dexmedetomidine in axillary brachial plexus block for post operative analgesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urmila Palaria |
| Designation |
Professor |
| Affiliation |
GMC Haldwani |
| Address |
Dr Urmila Palaria ,
Department of Anaesthesiology critical care ,pain and palliative Medicine Haldwani,Nainital Uttarakhand
Dr Urmila Palaria ,
Department of Anaesthesiology critical care ,pain and palliative Medicine Haldwani,Nainital Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897088443 |
| Fax |
|
| Email |
urmila_palaria@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Urmila Palaria |
| Designation |
Professor |
| Affiliation |
GMC Haldwani |
| Address |
Dr Urmila Palaria ,
Department of Anaesthesiology critical care ,pain and palliative Medicine Haldwani,Nainital Uttarakhand
Dr Urmila Palaria ,
Department of Anaesthesiology critical care ,pain and palliative Medicine Haldwani,Nainital Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897088443 |
| Fax |
|
| Email |
urmila_palaria@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Urmila Palaria |
| Designation |
Professor |
| Affiliation |
GMC Haldwani |
| Address |
Dr Urmila Palaria ,
Department of Anaesthesiology critical care ,pain and palliative Medicine Haldwani,Nainital Uttarakhand
Dr Urmila Palaria ,
Department of Anaesthesiology critical care ,pain and palliative Medicine Haldwani,Nainital Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897088443 |
| Fax |
|
| Email |
urmila_palaria@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ankita Rawat
Department of Anaesthesiology critical care ,pain and palliative Medicine Haldwani,Nainital Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Dr Ankita Rawat |
| Address |
GMC Haldwani campus
SR hostel room no. 29
nainital, uttarakhand |
| 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 Ankita Rawat |
Dr Susheela tiwari hospital ,GMC Haldwani |
Department of Anaesthesiology critical care ,pain and palliative Medicine Haldwani,Nainital Uttarakhand
Nainital
UTTARANCHAL |
9410702837
anki.raw17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE , GOVERNMENT MEDICAL COLLEGE HALDWANI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S599||Unspecified injury of elbow and forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ropivacaine 0.5% WITH 1 ML OF NORMAL SALINE for postoperative analgesia |
ropivacaine 0.5% WITH 1 ML OF NORMAL SALINE for postoperative analgesia |
| Intervention |
ropivacaine 0.5% with dexmedetomidine for postoperative analgesia |
ropivacaine 0.5% with dexmedetomidine for postoperative analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with ASA grade I and II.
2.Age group 18- 60 years
3 Patient undergoing upper limb surgery under axillary block
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.ASA grade III & IV patients
3.History of allergy or sensitivity to local anaesthetic or study drug
4. Known cardiovascular respiratory disease
5.Known hepato renal disease
6.Neuropsychiatric disorders
7.History of bleeding disorder..
8.Day care surgery
9.Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate for the duration of post-operative analgesia |
To evaluate for the duration of post-operative analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 .To evaluate the onset of sensory and motor block
2 To compare the complete effect of sensory and motor block
3. To assess for patient satisfaction
4. To evaluate the adverse effects like nausea, vomiting, dysarrhythmias, hypotension,
bradycardia, convulsions, sedation, neurological problems and hypersensitivity reaction for the study drug .
|
1.from administration of drug upto the 30 minutes of surgery for sensory and motor block assessment
2.Visual analogue scoring for oain from the point completion of surgery upto 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2020 |
| Date of Study Completion (India) |
25/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PATIENTS WERE DIVIDED INTO TWO GROUPS . ONE GROUP WILL BE GIVEN INJ ROPIVACAINE 0.5 % WITH 1 ML OF NORMAL SALINE AND ONE WILL BE GIVEN ROPIVACAINE 0.5% WITH DEXMEDETOMIDINE. ON ARRIVAL IN POST OPERATIVE ROOM , PATIENTS WILL BE ASSESSED FOR THE OCCURENCE OF PAIN ON 11 POINTS VISUAL ANALOG SCALE AND THIS WILL BE CONSIDERED AS 0 HOUR ,THEREAFTER THE OCCURRENCE OF PAIN AND HEMODYNAMIC PARAMETERS WILL BE ASSESSED EVERY 30 MINUTES FOR FIRST 6 HOURS AND THEN EVERY 6 HOURLY FOR UPTO 24 HOURS . INJECTION DICLOFENAC 75 mg INTAMUSCULAR WILL BE ADMINISTERED AS 1ST RESCUE ANALGESIC , WHEN VAS SCORE WILL BE MORE THAN EQUALS TO 4. INJECTION TRAMADOL50 mg INTRAMUSCULAR WILL BE ADMINISTERED AS 2ND RESCUE ANALGESIC .THE TIME BETWEEN THE END OF LOCAL NAESTHETC ADMINISTRATION AND 1ST RESCUE ANALGESIC ADMINISTRATION WILL BE RECORDED AS THE DURATION OF ANALGESIA |