| CTRI Number |
CTRI/2019/02/017415 [Registered on: 04/02/2019] Trial Registered Prospectively |
| Last Modified On: |
04/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of instillation of pain relieving drugs(bupivacaine- morphine) on nerves after spine surgery for post operative pain relief |
|
Scientific Title of Study
|
Efficacy Of Epidural Instillation (Bupivacaine- Morphine Cocktail) On Post-Operative Pain Management In Patients Undergoing Elective Lumbar Spine Surgery- A Prospective Randomised 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 Rishi kanna |
| Designation |
|
| Affiliation |
consultant spine surgeon and affiliation Ganga med center |
| Address |
Ganga medical centre and hospitals private limited.
313, mettupalayam road. coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
|
| Fax |
|
| Email |
rishiortho@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rishi kanna |
| Designation |
|
| Affiliation |
consultant spine surgeon and affiliation Ganga med center |
| Address |
Ganga medical centre and hospitals private limited.
313, mettupalayam road. coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
|
| Fax |
|
| Email |
rishiortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rishi kanna |
| Designation |
|
| Affiliation |
consultant spine surgeon and affiliation Ganga med center |
| Address |
Ganga medical centre and hospitals private limited.
313, mettupalayam road. coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
|
| Fax |
|
| Email |
rishiortho@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Medical Centre and Hospitals Private Limited
313, Mettupalayam Road, Coimbatore, 641043 |
|
|
Primary Sponsor
|
| Name |
Dr Rishi kanna |
| Address |
Ganga medical centre and hospitals private limited,313, mettupalayam road, coimbatore |
| 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 sridhar jakkepally |
ganga medical centre and hospitals private limited |
room no 501
research room
5th floor
ganga medical centre and hospitals private limited
Coimbatore
TAMIL NADU |
6303693627
sridhar.gmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
bupivacaine and morphine |
instill bupaivacaine- morphine cccktail over epidural space after lumbar surgery (decompression and discectomy) and assess the post operative pain scores |
| Comparator Agent |
no drug |
drug is not instilled over epidural space after elective lumbar surgery(decompression and discectomy) and assess post operative pain scores |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing elective lumbar spine surgery like lumbar decompressions and lumbar discectomies |
|
| ExclusionCriteria |
| Details |
less than 20 and more than 70yrs, infection and trauma patients
Patients with neurological deficits
Patients with postoperative drain and dural tears
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the post operative pain relief in patients undergoing elective lumbar spine surgery(lumbar decompressions and discectomies) |
to assess the post operative pain relief in patients undergoing elective lumbar spine surgery(lumbar decompressions and discectomies) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess recovery of patient during post operative period |
like early mobilization(less than 24 hrs) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/02/2019 |
| 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="0"
Months="3"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of Study:
To
assess whether epidural instillation of 0.25% bupivacaine and morphine reduces
the need of pain medication during post operative period in patients undergoing lumbar decompressions and discectomy
hypothesis: use of epidural instillation of bupivacaine- morphine cocktail, reduces post operative pain and reduces the need for post operative analgesics improves overall functional outcome in patients undergoing lumbar decompressions and discectomy |