| CTRI Number |
CTRI/2019/12/022437 [Registered on: 18/12/2019] Trial Registered Prospectively |
| Last Modified On: |
28/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"To compare epidural butorphanol with tramadol when given with bupivacaine for post operative pain relief in lower limb surgeries under spinal anaesthesia" |
|
Scientific Title of Study
|
"Comparison of epidural butorphanol with Tramadol as adjuvants to bupivacaine for post operative analgesia in infraumblical surgeries under spinal anaesthesia,a randomised controlled trial" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Dubey |
| Designation |
PG Resident |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesia, Peoples hospital, Bhanpur, Bhopal
Department of Anaesthesia, Peoples hospital, Bhanpur, Bhopal
Bhopal
MADHYA PRADESH
462016
India |
| Phone |
9713477838 |
| Fax |
|
| Email |
neha.g.dubey28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMahima Batra |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesia, Peoples hospital, Bhanpur, Bhopal
Department of Anaesthesia, Peoples hospital, Bhanpur, Bhopal
Bhopal
MADHYA PRADESH
462016
India |
| Phone |
9713477838 |
| Fax |
|
| Email |
drmahimabatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Dubey |
| Designation |
PG Resident |
| Affiliation |
Peoples college of medical sciences and research centre |
| Address |
Department of Anaesthesia, Peoples hospital, Bhanpur, Bhopal
Department of Anaesthesia, Peoples hospital, Bhanpur, Bhopal
Bhopal
MADHYA PRADESH
462016
India |
| Phone |
9713477838 |
| Fax |
|
| Email |
neha.g.dubey28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples Hospital,Bhanpur,Bhopal |
|
|
Primary Sponsor
|
| Name |
Neha Dubey |
| Address |
MIG- 274, E-7, Arera colony, bhopal |
| Type of Sponsor |
Other [INDIVIDUAL] |
|
|
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 |
| Neha Dubey |
Peoples Hospital |
Ayodhya by Pass Road, Bhanpur
Bhopal
MADHYA PRADESH |
9713477838
neha.g.dubey28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , PCMS &RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S729||Unspecified fracture of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1mg tramadol and 1 mg butorphanol |
as adjuvants to.125%
8 ml bupivacaine in epidural for post operative analgesia, every 6 hours for 1 day. |
| Comparator Agent |
Comparison of epidural 1 mg butorphanol and 1 mg tramadol |
as adjuvants to bupivacaine 8 ml, .125% in epidural for post operative analgesia for every 6 hours for 1 day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 & 2, patients admitted for lower limb surgeries |
|
| ExclusionCriteria |
| Details |
ASA grade 3 & 4, allergy to study drugs, HR<50/MIN, SBP< 100 mm hg, contraindications to regional anaesthesia. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post Operative Analgesia |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post Operative Analgesia |
30 minutes |
|
|
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)
|
25/12/2019 |
| 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="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
|
To minimise post operative pain in patients in lower limb surgeries, and difference in onset,duration of analgesia and side effects of tramadol and butorphanol with bupivacaine given epidurally. to use the longer acting drug to provide analgesia. |