| CTRI Number |
CTRI/2020/02/023181 [Registered on: 07/02/2020] Trial Registered Prospectively |
| Last Modified On: |
02/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare Fentanyl and Butorphanol as adjuvant drugs to local anesthetics in combined spinal and epidural anaesthesia in surgeries on legs |
|
Scientific Title of Study
|
Comparison between fentanyl and butorphanol as epidural adjuvants in combined spinal epidural anaesthesia for lower limb surgeries - A prospective randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sangeetha G G |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9840769194 |
| Fax |
|
| Email |
prithi2293@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S N Krishnamoorthy |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9786743120 |
| Fax |
|
| Email |
esenkeyem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sangeetha G G |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9840769194 |
| Fax |
|
| Email |
prithi2293@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram 503108 Tamil Nadu India |
|
|
Primary Sponsor
|
| Name |
Sangeetha G G |
| Address |
Plot No: 31, second Street,
Ravi Colony, St. Thomas Mount,
Chennai 600016, Tamil Nadu |
| 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 |
| Sangeetha G G |
Shri Sathya Sai Medical College and Research Institute |
Room number 3, Orthopaedics department, Second Floor, OT Complex, Thiruporur Guduvanchery Main Road, Ammapettai Nellikuppam, Kancheepuram 603108 Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
9840769194
prithi2293@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M80-M85||Disorders of bone density and structure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Butorphanol |
At the end of surgery, Epidural bolus of 10ml 0.125% Bupivacaine with 10mcg/kg of Butorphanol will be given for post-operative pain relief |
| Intervention |
Fentanyl |
At the end of surgery, Epidural bolus of 10ml 0.125% Bupivacaine with 1mcg/kg of Fentanyl will be given for post-operative pain relief |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective lower limb surgeries under combined spinal and epidural anaesthesia
American Society of Anaesthesiologist I or II |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients allergic to local anesthetics/Butorphanol/Fentanyl
American Society of Anaesthesiologist III and above
Patients with coagulation disorders
Local site infection
BMI above 30
Poorly controlled Hypertension
Poorly controlled Diabetes mellitus
Patients with cardiac pathology
Pregnant patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the quality and duration of analgesia postoperatively using Visual analogue scale and time of requirement of rescue analgesia respectively |
Postoperative Period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess sedation score and adverse effects such as pruritis, nausea and vomiting, shivering, hemodynamic stability up to 24 hours postoperatively between the two groups |
Postoperative Period |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
10/02/2020 |
| 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="6"
Days="0" |
|
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
|
This is a randomized controlled trial to compare the efficacy of Fentanyl and Butorphanol as adjuvants to combined spinal epidural anaesthesia among 46 patients posted for lower limb surgeries over a period of 18 months. The primary objective is to determine the quality and duration of analgesia post-operatively. The secondary outcomes are to assess sedation score and incidence of adverse effects such as pruritis, nausea, vomiting, shivering, hemodynamic instability. |