| CTRI Number |
CTRI/2020/05/025387 [Registered on: 27/05/2020] Trial Registered Prospectively |
| Last Modified On: |
11/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of analgesic Pregabalin for pain after surgical management of trauma |
|
Scientific Title of Study
|
The Effectiveness of Preemptive Analgesia with Pregabalin in Surgical Management of Maxillofacial Trauma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subhashini R |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Oral and Maxillofacial surgery,Saveetha Dental College,162, Poonamallee high road, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9976874142 |
| Fax |
|
| Email |
meetsubha07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P U Abdul Wahab |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Oral and Maxillofacial surgery,Saveetha Dental College,162, Poonamallee high road, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9884455480 |
| Fax |
|
| Email |
docwahab@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P U Abdul Wahab |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Oral and Maxillofacial surgery,Saveetha Dental College,162, Poonamallee high road, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9884455480 |
| Fax |
|
| Email |
docwahab@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College, 162, Poonamallee High road, Velappanchavadi, Chennai, Tamil Nadu-600017 |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College |
| Address |
Saveetha Dental College, 162, Poonamallee High road, Velappanchavadi,Chennai, TamilNadu-600077 |
| Type of Sponsor |
Other [Saveetha Dental 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 Subhashini R |
Saveetha Dental College |
Clinic 20
Department of Oral and Maxillofacial surgery,Saveetha Dental College,162, Poonamallee high road, Velappanchavadi
Chennai
TAMIL NADU |
9976874142
meetsubha07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S029||Fracture of unspecified skull andfacial bones, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Pregabalin 75mg |
Pregabalin Capsules IP 75mg Orally one hour before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing surgery for Maxillofacial trauma |
|
| ExclusionCriteria |
| Details |
Patients who have systemic diseases and other Co-Morbidities |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post Operative Pain Management |
1,6,12,24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the need for rescue analgesia |
1,6,12,24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 1 |
|
Date of First Enrollment (India)
|
01/06/2020 |
| 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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pain is one of the most common clinical problems , especially in post operative patients. Reducing pain increases patients satisfaction and it decreases hospitalization period. Preemptive analgesia is the use of analgesic agents before doing any surgical procedure.So that the need for rescue analgesia is reduced. The aim of this study is to assess the preemptive analgesic effect of Pregabalin |