| CTRI Number |
CTRI/2020/07/026388 [Registered on: 06/07/2020] Trial Registered Prospectively |
| Last Modified On: |
01/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of 2-chloroprocaine by adding fentanyl and dexmedetomidine in short duration orthopaedic surgeries |
|
Scientific Title of Study
|
Comparison of the efficacy of fentanyl and dexmedetomidine as adjuvants to intrathecal 2-chloroprocaine for elective lower limb orthopaedic surgeries- a prospective, randomized, double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MANOJ SANKALA |
| Designation |
Resident MD Anesthesiology |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
SVIMS, Tirupathi
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9701418841 |
| Fax |
|
| Email |
manojmighty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JANAKI SUBHADRA PEYYETY |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
SVIMS, Tirupathi
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9493547655 |
| Fax |
|
| Email |
subhadrapeyyety@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MANOJ SANKALA |
| Designation |
Resident doctor, MD Anaesthesiology |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
SVIMS, Tirupathi
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9701418841 |
| Fax |
|
| Email |
manojmighty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences Alipiri road Tirupati 517501 |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Sri Venkateswara Institute of Medical Sciences Alipiri road Tirupati 517501 |
| 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 |
| Dr Manoj Sankala |
Balaji Institute of Surgery, Research and Rehabilitation for Disabled |
Department of Anaesthesiology,OT complex, Alipiri road Tirupati Chittoor district
Chittoor
ANDHRA PRADESH |
9701418841
manojmighty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S80-S89||Injuries to the knee and lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SPINAL ANAESTHESIA |
4ml of 2-chloroprocaine |
| Comparator Agent |
SPINAL ANAESTHESIA |
4ml of 2-chloroprocaine is added to 25 mcg of fentanyl and 5 mcg of dexmedetomidine |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of American society of Anesthesiologists physical status grade 1 and 2
2. Patients of age group between 20 to 65 years
3. patients posted for elective lower limb orthopaedic surgeries with duration of 1.5 to 2 hrs |
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to participate in the study.
2. Patients who do not give consent for spinal anaesthesia.
3. H/o spinal surgeries.
4. H/o coagulation and bleeding disorders.
5. Local site infections.
6. H/o hypersensitivity to study drugs.
7. H/o uncontrolled HTN and DM & H/o CAD.
8. Increased serum creatinine and liver enzymes:
2-3 times of normal.
9. H/o neuropsychiatric disorders and communication problems
10. Patients who cannot understand visual analog scale (VAS) measurements.
11. Pregnant women and lactating mothers.
12. Height-<140 cm & BMI > 35 Kg/m2.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
Time of the first analgesic request |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Onset of sensory block
2.Onset of motor block
3.Height of the sensory block
4.Duration of sensory block
5.Duration of motor block
6.Regression time below L1
7.VAS score of pain
8.VAS score of patient satisfaction
9.Adverse hemodynamic effects during the study period
|
0,3 min, 6 min, 9 min, 12 min, 15 min, 30 min, 45 min, 60 min, 2 hrs, 3 hrs and 4 hrs after injection of study drug.
|
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
13/07/2020 |
| 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="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
|
This study is to compare the efficacy of fentanyl and dexmedetomidine as an adjuvants to intrathecal 2-chloroprocaine among the patients posted for elective lower limb orthopaedic surgeries. 4ml of 2-chloroprocaine is the study drug in which 25 mcg of preservative free fentanyl is added as an adjuvant in one group and 5 mcg of dexmedetomidine is added in another group. Study ends when patient complains pain after giving the drug. onset,duration of sensory and motor block ,height of the sensory block, regression time of L1 dermatome is studied. Visual Analog Scale(VAS), and Visual analogue Scale of patient satisfaction (VAS scores of patient satisfaction) is used to assess the pain and satisfaction at the drug in patient. Adverse effects of the study drugs will be studied and manageed during study period .
Our study intends to prove that 2-chloroprocane can be used by adding adjuvants such as fentanyl and dexmedetomidine in short duration lower limb orthopaedic surgeries. |