| CTRI Number |
CTRI/2019/11/021902 [Registered on: 06/11/2019] Trial Registered Prospectively |
| Last Modified On: |
04/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare pain relief for block performed before and after surgery in patients having surgeries in the jaw |
|
Scientific Title of Study
|
A Randomized Control Trial to Compare Efficacy of Ultrasound - Guided Mandibular Nerve Block Performed Postoperatively with Preemptive Block in Mandibular Surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajagopalan Venkatraman |
| Designation |
Professor |
| Affiliation |
Srm Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology Srm Medical College Hospital Potheri
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09894581455 |
| Fax |
|
| Email |
drvenkat94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajagopalan Venkatraman |
| Designation |
Professor |
| Affiliation |
Srm Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology Srm Medical College Hospital Potheri
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09894581455 |
| Fax |
|
| Email |
drvenkat94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Belinda Cherian |
| Designation |
Postgraduate |
| Affiliation |
Srm Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology Srm Medical College Hospital Potheri
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8139825608 |
| Fax |
|
| Email |
belindacherian93@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Institute of Science and Technology, Srm nagar, Potheri, kancheepuram District, Tamilnadu - 603203. |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital |
| Address |
Room no 1, B Block, Department of Anaesthesiology Potheri Kattankulathur 603203 Kancheepuram TAMIL NADU |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rajagopalan Venkatraman |
SRM Medical College Hospital |
Room no 1, B Block, Department of Anaesthesiology Srm Medical College Hospital Potheri Kattankulathur
Kancheepuram
TAMIL NADU |
9894581455
drvenkat94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S02||Fracture of skull and facial bones, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mandibular nerve block |
It is a block performed using ultrasound in the perimandibular space |
| Comparator Agent |
pre-emptive and postoperative |
The mandibular nerve block is performed either prior to surgery or in the immediate postoperative period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA Physical Status I and II posted for fractures of mandible |
|
| ExclusionCriteria |
| Details |
1. All patients with ASA Physical Status III and above
2. Patients who refuse to participate in the study
3. Patients who are allergic to amide local anaesthetics
4. Patients who are pregnant
5. Patients with chronic cardiac, renal or hepatic condition
6. Patients with coagulation abnormalities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia |
within 24 hours of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic parameters |
The heart rate,and blood pressure intraoperatively will be observed. |
| Morphine consumption |
The total consumption of morphine in the first 24 hours in PCA pump will be recorded |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
18/11/2019 |
| 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 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
|
Patients posted for mandibular fracture fixation surgeries will be included in the study. The patients will be randomly divided into two groups. Group A will receive mandibular nerve block after anaesthesia induction and endotracheal intubation and prior to surgical incision. Group B patients will receive mandibular nerve block at the end of surgery. Both the blocks will be performed with the aid of ultrasound and using Ropivacaine 0.5% 10ml. The general anaesthesia will be standardized in both the groups. At the end of sugery, the patient will be put on patient controlled analgesia (PCA) using morphine with bolus of 1mg and lockout interval of 10 minutes. The duration of postoperative analgesia, consumption of morphine in PCA and haemodynamic parameters will be obseved in both the groups and compared. Descriptive statics ( mean , standard deviation, and frequency ) will be included . to compare quantitive data , chi-square test was used . the results will be expressed in 95% confidence interval . a valve of p<0.05 will be considered to be statistically significant.
|