| CTRI Number |
CTRI/2019/03/018170 [Registered on: 19/03/2019] Trial Registered Prospectively |
| Last Modified On: |
26/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Compare Two Local Anesthetic Drugs In Minor Oral Surgical Procedures. |
|
Scientific Title of Study
|
A Randomized Clinical Trial Comparing 0.75% Ropivacaine And 2% Lignocaine With 1 : 200000 Adrenaline In Minor Oral Surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishwajeet Singh Jamwal |
| Designation |
Post graduate |
| Affiliation |
Dr. Harvansh Singh Judge Institute Of Dental Sciences and Hospital,Panjab University,Chandigarh |
| Address |
Room no. 5
Department Of Oral and Maxillofacial Surgery
Dr. Harvansh Singh Judge Institute Of Dental Sciences and Hospital,Panjab University,Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9149774489 |
| Fax |
|
| Email |
vish1806singh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant batra |
| Designation |
HOD |
| Affiliation |
Dr. Harvansh Singh Judge Institute Of Dental Sciences and Hospital,Panjab University,Chandigarh |
| Address |
Room no. 5
Department Of Oral and Maxillofacial Surgery
Dr. Harvansh Singh Judge Institute Of Dental Sciences and Hospital,Panjab University,Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9814555550 |
| Fax |
|
| Email |
hemant_batra69@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishwajeet Singh Jamwal |
| Designation |
Post graduate |
| Affiliation |
Dr. Harvansh Singh Judge Institute Of Dental Sciences and Hospital,Panjab University,Chandigarh |
| Address |
Room no. 5
Department Of Oral and Maxillofacial Surgery
Dr. Harvansh Singh Judge Institute Of Dental Sciences and Hospital,Panjab University,Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9149774489 |
| Fax |
|
| Email |
vish1806singh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Oral and Maxillofacial Surgery,
Dr. Harvansh Singh Judge Institute Of Dental Sciences And Hospital,Panjab University, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Vishwajeet Singh Jamwal |
| Address |
Room no. 5
Department Of Oral and Maxillofacial Surgery,
Dr. Harvansh Singh Judge Institute Of Dental Sciences And Hospital,Panjab University, Chandigarh
160014
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Harsimran Kaur |
Department Of Oral and Maxillofacial Surgery, Dr. Harvansh Singh Judge Institute Of Dental Sciences And Hospital,Panjab University, Chandigarh
|
| Dr Hemant Batra |
Department Of Oral and Maxillofacial Surgery, Dr. Harvansh Singh Judge Institute Of Dental Sciences And Hospital,Panjab University, Chandigarh |
| Dr Vandana Chhabra |
Department Of Oral and Maxillofacial Surgery, Dr. Harvansh Singh Judge Institute Of Dental Sciences And Hospital,Panjab University, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vishwajeet Singh Jamwal |
Dr. Harvansh Singh Judge Institute Of Dental Sciences and Hospital ,Panjab University , Chandigarh |
Room no. 5
Department Of Oral and Maxillofacial Surgery
Chandigarh
CHANDIGARH |
9149774489
vish1806singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Degree Committee Dr. Harvansh Singh Judge Institute Of Dental Sciences and Hospital ,Panjab University , Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.75% Ropivacaine hydrochloride |
Infraorbital nerve block -1.2ml
Greater palatine nerve block - 0.5ml
Posterior superior alveolar nerve block - 1.8ml
Inferior alveolar nerve block - 1.5ml
Long buccal nerve block - 0.3ml
lingual nerve block - 0.2ml |
| Comparator Agent |
2% Lignocaine hydrochloride with 1:200000 adrenaline |
Infraorbital nerve block -1.2ml Greater palatine nerve block - 0.5ml Posterior superior alveolar nerve block - 1.8ml Inferior alveolar nerve block - 1.5ml Long buccal nerve block - 0.3ml lingual nerve block - 0.2ml |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA 1
2. Patients not receiving any medications that will alter the perception of pain.
3. Patients requiring extraction of bilaterally symmetrical teeth.
|
|
| ExclusionCriteria |
| Details |
1. Patients with history of allergic reactions to LA of amide group and sulfides.
2. Patients with acute infections.
3. Patients taking medications like MAO inhibitors, tricyclic antidepressants , phenothiazines ,vasodepressor drugs
4. Pregnant and lactating patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset and duration of anesthesia and analgesia, Cardiovascular effects,VAS pain score.
|
Preoperatively,
Intraoperatively at 5 minutes interval and postoperatively as required. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of additional blocks /infiltration required or any other adverse effect.
|
Intraoperatively and postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/03/2019 |
| Date of Study Completion (India) |
22/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
http://dx.doi.org/10.1016/j.bjoms.2015.02.021
doi:10DOI: http://dx.doi.org/10.13005/bpj/435.1053/joms.2002.34409
DOI: 10.4103/0019-5049.79875
DOI 10.1007/s12663-016-0902-x
doi:10.1016/j.ijom.2009.11.009 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ropivacaine hydrochloride being a long acting amide local anesthetic having long duration ( 6-7 hours) of action can be beneficial in minor oral surgical procedures like surgical extraction of impacted teeth , enucleation of small cysts ,fracture reduction ,intermaxillary fixation etc.These procedures are routinely carried out under local anesthesia but require repeated infiltration or nerve blocks with more conventional drug i.e Lignocaine hydrochloride with 1:200000 adrenaline having moderate duration of action ranging from 120-150 minutes. In patients with CVS problems in whom adrenaline is contraindicated and plain Lignocaine without vasoconstrictor fails to provide effective anesthesia for required duration , Ropivacaine hydrochloride can provide effective anesthesia. |