| CTRI Number |
CTRI/2020/06/026160 [Registered on: 26/06/2020] Trial Registered Prospectively |
| Last Modified On: |
24/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of pain relief after lower abdominal surgeries using dexmedetomidine and nalbuphine with bupivacaine in spinal anaesthesia |
|
Scientific Title of Study
|
A study to compare the efficacy of intrathecal dexmedetomidine versus nalbuphine as an adjuvant to 0.5% hyperbaric bupivacaine for post operative analgesia in lower abdominal surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Kumar Chohala |
| Designation |
Resident |
| Affiliation |
JLN Medical college Ajmer |
| Address |
Deptt. of anaesthesiology ,New OT J.L.N. hospital Bajrang garh, Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9001686486 |
| Fax |
|
| Email |
chohala.mukesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrArvind Khare |
| Designation |
Professor |
| Affiliation |
JLN Medical college, Ajmer |
| Address |
Deptt. of anaesthesiology ,New OT J.L.N. hospital Bajrang garh, Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrArvind Khare |
| Designation |
Professor |
| Affiliation |
JLN Medical college, Ajmer |
| Address |
Deptt. of anaesthesiology ,New OT J.L.N. hospital Bajrang garh, Ajmer
RAJASTHAN
305001
India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
|
Source of Monetary or Material Support
|
| J L N Medical College and Hospital Ajmer |
|
|
Primary Sponsor
|
| Name |
J L N Medical College and Hospital |
| Address |
Deptt. of anaesthesiology ,New OT J.L.N. hospital Bajrang garh Ajmer |
| Type of Sponsor |
Government medical 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 Arvind Khare |
J L N Medical College and Hospital |
Deptt. of anaesthesiology ,New OT J.L.N. medical college and hospital, Ajmer
Ajmer
RAJASTHAN |
9414306114
arvindkhare68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee J.L.N. Medical College Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, (2) ICD-10 Condition: K36||Other appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine 10 mcg and Nalbuphine 1 mg with Bupivacaine Heavy 0.5% 3.6ml |
Compare the duration of analgesia |
| Intervention |
Intrathecal block |
Duration of analgesia is assessed and duration of study is around 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA grade 1 and 2
Informed consent
undergoing infraumbilical surgery
|
|
| ExclusionCriteria |
| Details |
Patient’s refusal
Uncooperative patients
Patient undergoing caesarean section
Any known hypersensitivity or contraindication to Bupivacaine, Dexmedetomidine and Nalbuphine hydrochloride
Local pathology at the site of injection or disability limiting the performance of spinal block
History of convulsion, bleeding disorder, severe neurological deficit, thyroid disorder
Patient with history of respiratory, cardiac, hepatic or renal disease (necessitating classification in ASA Class III or above)
Patients having a history of significant neurological, psychiatric, or neuromuscular disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset and two segment regression of sensory block.
Onset and duration of motor block.
Peri-operative sedation score
Haemodyanamic changes.
Adverse effect if any.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/07/2020 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of our study is to compare the efficacy of intrathecal dexmedetomidine 10 microgram versus nalbuphine hydrochloride 1 milligram as an adjuvant to 0.5% hyperbaric bupivacaine in lower abdominal surgeries under spinal anaesthesia with primary objective as duration of analgesia and secondary objective as onset and two segment regression of sensory block, onset and duration of motor block, peri-operative sedation score, haemodyanamic changes, adverse effect if any. |