| CTRI Number |
CTRI/2021/07/034908 [Registered on: 15/07/2021] Trial Registered Prospectively |
| Last Modified On: |
14/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two drugs with local anesthetic drug for postoperative epidural analgesia in lower limb orthopedic surgeries |
|
Scientific Title of Study
|
A prospective randomized clinical study to compare the
effect of buprenorphine and fentanyl as adjuvants to
bupivacaine for post operative epidural analgesia in lower
limb orthopedic 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 Namratha B M |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College Hospital & Research Centre |
| Address |
B25, BLDE Nri hostel , Shri B M Patil Medical College Hospital Research Centre , Vijayapura , Karnataka
Department of Anaesthesia , Shri B M Patil Medical College Hospital Research Centre , Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9945980378 |
| Fax |
|
| Email |
bmnamratha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renuka Holyachi |
| Designation |
Assistant professor in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College Hospital & Research Centre |
| Address |
Department of anesthesiology, Shri B M Patil Medical College Hospital Research Centre , Vijayapura , Karnataka
Department of Anaesthesia , Shri B M Patil Medical College Hospital Research Centre , Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9945980378 |
| Fax |
|
| Email |
renuka312@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namratha B M |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College Hospital & Research Centre |
| Address |
B25, BLDE Nri hostel , Shri B M Patil Medical College Hospital Research Centre , Vijayapura , Karnataka
Department of Anaesthesia , Shri B M Patil Medical College Hospital Research Centre , Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9945980378 |
| Fax |
|
| Email |
bmnamratha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology ,shri b m patil medical college , blde University , vijayapur , Karnataka |
|
|
Primary Sponsor
|
| Name |
BLDE deemed to be university |
| Address |
Shri B M Patil Medical College Hospital Research Centre BLDE (deemed to be university) Vijayapura |
| Type of Sponsor |
Private 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 |
| Namratha B M |
Shri B M Patil Medical College Hospital |
Department Of Anesthesiology , Third floor , no 405, Shri B M Patil Medical College Hospital Research Centre BLDE deemed to be university Vijayapura
Bijapur
KARNATAKA |
9945980378
bmnamratha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee blde |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Buprenophine vs Fentanyl |
Comparison of postoperative epidural analgesia by administering bupivacaine 2ml with buprenophine 1.5mcg/kg diluted to 10ml with distilled water vs bupivacaine 2ml with Fentanyl 1mcg/kg diluted with distilled water to 10ml |
| Intervention |
Epidural Analgesia |
18G Epidural catheter placement and administering drugs postoperatively for epidural analgesia. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 only. |
|
| ExclusionCriteria |
| Details |
patient refusal. contraindication for epidural . pregnant women. cardiorespiratory , hepatic, renal , neurological , blood disorders. Deformities of spine. ASA 3 and 4. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score less than 5 after administration of epidural drug. |
Postoperative every 5minutes til first hour and then hourly for 24hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hemodynamic outcomes after drug administration and any adverse effects |
postoperatively every 5minutes for first hour and then hourly for 24hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2021 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
During the above study period 60 patients posted for lower limb orthopedic surgeries will undergo Spinal anesthesia + Epidural analgesia. Pre-anesthetic evaluation will be done . patients will be shifted to Ot and all standard monitors attached. Patient will be premedicated with Ondansetron 4mg IV. In supine or lateral position 20G portex epidural catheter will be inserted via an 18G Tuohy needle by loss of resistance to air technique and fixed after giving test dose. A 25G spinal needle will be inserted in l3 l4 interspace and after confirming free flow of csf spinal anesthesia given with bupivacaine. patient monitored intraoperatively . In the post-operative period when patient complains of pain and VAS score is above 5 study drug will be given through epidural catheter Group A- 2ml 0.5% bupivacaine + 1.5mcg/kg buprenorphine diluted with distilled water upto 10ml Group B- 2ml bupivacaine + 1mcg/kg fentanyl diluted with distilled water upto 10ml the patient pulse rate , blood pressure ans vas score will be recorded every 5 minutes for first half hour followed by every hour. |