| CTRI Number |
CTRI/2021/05/033559 [Registered on: 12/05/2021] Trial Registered Prospectively |
| Last Modified On: |
11/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON BETWEEN LEVOBUPIVACAINE PLUS DEXMEDETOMIDINE V/S LEVOBUPIVACAINE PLUS CLONIDINE IN TAP BLOCK FOR POSTOPERATIVE ANALGESIA FOLLOWING INGUINAL HERNIA REPAIR |
|
Scientific Title of Study
|
COMPARISON OF DEXMEDETOMIDINE AND CLONIDINE AS AN ADJUVANT TO LEVOBUPIVACAINE IN TRANSVERSUS ABDOMINIS PLANE BLOCK FOR POSTOPERATIVE ANALGESIA FOLLOWING INGUINAL HERNIA REPAIR |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indresh Yadav |
| Designation |
PG Student |
| Affiliation |
Dr. Bhimrao Ambedkar Memorial Hospital, Raipur |
| Address |
Department of Anaesthesiology, Pt.J.N.M.Medical College, Raipur, CHHATTISGARH
Dr.BRAMH,Raipur, Jail road
Raipur
CHHATTISGARH
492001
India |
| Phone |
8109938709 |
| Fax |
|
| Email |
indreshyadav91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Thakur |
| Designation |
Associate Professor |
| Affiliation |
Dr. Bhimrao Ambedkar Memorial Hospital, Raipur |
| Address |
Department of Anesthesiology, Pt.J.N.M. Medical College, Raipur, CHHATTISGARH
Dr.BRAMH, jail road, Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827485021 |
| Fax |
|
| Email |
rash15nov@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indresh Yadav |
| Designation |
PG Student |
| Affiliation |
Dr. Bhimrao Ambedkar Memorial Hospital, Raipur |
| Address |
Department of Anesthesiology, Pt.J.N.M. Medical College, Raipur, CHHATTISGARH
DR.BRAMH, Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
8109938709 |
| Fax |
|
| Email |
indreshyadav91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Bhimrao Ambedkar memorial Hospital, Raipur |
|
|
Primary Sponsor
|
| Name |
Dr Rashmi Thakur |
| Address |
Department of Anesthesiology, Pt,J.N.M.Medical College, Raipur |
| 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 Indresh Yadav |
Dr Bhimrao Ambedkar Memorial Hospital |
Department of Anesthesiology and critical care, Pt.J.N.M Medical college, raipur (C.G.)
Raipur
CHHATTISGARH |
8109938709
indreshyadav91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Pt.J.N.M.Medical college, Raipur, C.G |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj Levobupivacaine 0.5% with inj Clonidine 1mcg/kg in TAP block |
inj Levobupivacaine 0.5% with inj Clonidine 1mcg/kg in TAP block for post operative analgesia |
| Intervention |
inj Levobupivacaine 0.5% with inj Dexmedetomidine 1mcg/kg in TAP block |
inj Levobupivacaine 0.5% with inj Dexmedetomidine 1mcg/kg in TAP block for post operative analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Asa grade I & II
age group 18-65 years
height 140-170cm
weight 30-90 kg
BMI<30 kg/m2
male patients who will be undrgoing elective, uncomplicated inguinal hernia reapir under subarachnoid block |
|
| ExclusionCriteria |
| Details |
1.Refusal to enroll
2. Non-cooperative patients
3. Pre-existing abdominal pain.
4. Patients on analgesic drugs.
5. Duration of surgery>2 hours
6. Any intraoperative surgical complications.
7. Systemic disorders- liver, kidney, cardiac, respiratory, neurological, psychiatric disorders and bleeding tendencies.
8. Patients with history of allergic reactions to local anesthetics.
9. Presence of any contraindication to neuraxial anesthesia. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of analgesia with dexmedetomidine and clonidine as an adjuvant to levobupivacaine in TAP block. |
Within 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of pain relief as assessed by VAS.
Total dose of rescue analgesic in 24 hours.
Incidence of side effects(like sedation,nausea,vomiting, bradycardia,hypotension.
|
within 24 hours |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
17/05/2021 |
| 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="0"
Months="6"
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)?
Response - NO
|
|
Brief Summary
|
This is a interventional comparative randomized study to see the effect of dexmedetomidine and clonidine as an adjuvant to levobupivacaine in TAP block for post operative analgesia in 74 patients of age group 18 to 65 years with ASA physical status I-II undergoing unilateral uncomplicated inguinal hernia .It will be conducted at single center in India. Primary outcome measures will be duration of analgesia with dexmedetomidine and clonidine as an adjuvant to levobupivacaine in TAP block. Secondary outcome will be quality of pain relief, total dose of rescue analgesic in24 hours and incidence of side effects. |