| CTRI Number |
CTRI/2023/05/052455 [Registered on: 10/05/2023] Trial Registered Prospectively |
| Last Modified On: |
09/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate and study analgesic effect of fentanyl as an additive to intrathecal hyperbaric ropivacaine for lower limb surgery |
|
Scientific Title of Study
|
Evaluation of the analgesic effect of fentanyl as an additive to intrathecal hyperbaric ropivacaine for lower limb surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarvjeet Kaur |
| Designation |
Head of Department |
| Affiliation |
GGSMCH FARIDKOT |
| Address |
Department of Anaesthesiology
Guru Gobind Singh Medical College and Hospital, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvjeet Kaur |
| Designation |
Head of Department |
| Affiliation |
GGSMCH FARIDKOT |
| Address |
Department of Anaesthesiology
Guru Gobind Singh Medical College and Hospital, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aashima Mahajan |
| Designation |
Junior Resident |
| Affiliation |
GGS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anaesthesiology
GGS medical college and hospital
Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
7009055386 |
| Fax |
|
| Email |
aashimamahajan89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia , GGSMCH Faridkot |
|
|
Primary Sponsor
|
| Name |
Dr. Sarvjeet Kaur |
| Address |
Department of Anaesthesiology,
GGSMCH, FARIDKOT |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Amanjot Singh |
Department of Anaesthesiology
GGSMCH, Faridkot |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr AASHIMA MAHAJAN |
GGSMCH |
Department of Anaesthesiology
GGS MEDICAL COLLEGE AND HOSPITAL , FARIDKOT 151203
Faridkot
PUNJAB |
7009055386
aashimamahajan89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee |
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 |
Ropivacaine |
3 ml of 0.75 %ropivacaine and 0.5 ml of Normal Saline intrathecally while giving spinal anaesthesia to assess total duration of analgesia till 24 hours of surgery. |
| Intervention |
Ropivacaine with fentanyl |
3ml of 0.75%ropivacaine with 0.5ml of fentanyl intrathecally while giving spinal anaesthesia to assess total duration of analgesia till 24 hours after surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients scheduled for elective lower limb surgeries under spinal anaesthesia.
2.Patients aged between 18-60 years of either gender, giving valid informed and written consent.
3.Patients belonging to American Society of Anaesthesiology (ASA) grade I and II.
|
|
| ExclusionCriteria |
| Details |
1.Patient with Known allergy to drugs used in study
2.Any contraindications to spinal anaesthesia
3.Coagulopathy and bleeding diathesis
4.Patients diagnosed with psychiatric ailments
5.History of drug/substance abuse
6.Patients on anti arrhythmic treatment
BMI>35 kg/m2
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study duration of analgesia with intrathecal ropivacaine in lower limb surgery.
2.To study duration of analgesia with intrathecal ropivacaine and fentanyl in lower limb surgery.
3.To compare duration of analgesia with intrathecal ropivacaine versus intrathecal ropivacaine with fentanyl in lower limb surgery.
|
Outcome will be assessed at the end of study that is 12 months |
|
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Secondary Outcome
|
|
|
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)
|
20/05/2023 |
| 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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION: Spinal anaesthesia has been a widely used, safe and effective form of anaesthesia for lower abdominal and extremity surgeries. Intrathecal ropivacaine as a local anaesthetic drug has been introduced into clinical practice as it meets the desired goals of anaesthesia while minimizing the potential side effects. The addition of different adjuvants along with local anaesthetic has shown to have synergistic effect by prolonging the analgesic property and the duration of sensory-motor blockade and decreasing the dose requirement of local anaesthetic. Fentanyl in this regard has also shown some promising effects. The addition of intrathecal fentanyl to ropivacaine may improve the quality of block and early postoperative mobility. Thus we compare the use of ropivacaine along with an adjunct (fentanyl) versus a single agent to attain the desired anesthetic effect while minimizing the associated side effects.
AIMS AND OBJECTIVES: Our aim is to compare analgesic efficacy of intrathecal ropivacaine with fentanyl versus ropivacaine alone in lower limb surgeries.We will compare the onset and duration of sensory blockade and motor blockade and maximum height of sensory blockade achieved. We will also look for safety and side effects, if any in both the groups. |