| CTRI Number |
CTRI/2025/06/088008 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of fentanyl vs butorphanol in heavy levobupivacaine as a drug in spinal for pain relief in patients undergoing infra umbilical surgery |
|
Scientific Title of Study
|
Comparative study of intrathecal fentanyl vs butorphanol along with heavy levobupivacaine for analgesic efficacy in adult patients undergoing elective infra umbilical surgery |
| Trial Acronym |
NIL |
|
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 |
Professor and Head |
| Affiliation |
Professor, Dept of Anaesthesia |
| Address |
Department of Anaesthesiology
Guru Gobind Singh Hospital and Medical College
Faridkot , Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvjeet Kaur |
| Designation |
Professor and Head |
| Affiliation |
Professor, Department of Anaesthesia |
| Address |
Department of Anaesthesiology
Guru Gobind Singh Hospital and Medical College
Faridkot , Punjab
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvjeet Kaur |
| Designation |
Professor and Head |
| Affiliation |
Professor, Department of Anaesthesia |
| Address |
Department of Anaesthesiology
Guru Gobind Singh Hospital and Medical College
Faridkot , Punjab
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology
Guru gobind singh hospital and medical college
Faridkot , Punjab |
|
|
Primary Sponsor
|
| Name |
Dr Sarvjeet kaur |
| Address |
Department of Anaesthesiology
Guru Gobind Singh Hospital and Medical College
Faridkot , Punjab |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Haramritpal kaur |
Dept of anesthesia
GGS MCH 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 Bhawna |
Guru Gobind singh medical college and hospita |
Department of Anaesthesiology
Guru Gobind Singh Hospital and Medical College
Faridkot , Punjab
151203
Faridkot
PUNJAB |
7494956303
Mehndirattabhawna8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of GGSMCH, Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S70-S79||Injuries to the hip and thigh, (2) ICD-10 Condition: S80-S89||Injuries to the knee and lower leg, (3) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, (4) ICD-10 Condition: M232||Derangement of meniscus due to oldtear or injury, (5) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal Levobupivacaine with butorphanol |
To evaluate duration of sensory block with intrathecal 0.5percent levobupivacaine
and 250 mcg butrophanol. |
| Comparator Agent |
Intrathecal Levobupivacaine with fentanyl |
To evaluate duration of sensory block with intrathecal 0.5percent levobupivacaine
and 25 mcg fentanyl |
| Intervention |
Intrathecal levobupivacaine with NS |
To evaluate duration of sensory block with intrathecal 0.5percent levobupivacaine
and 0.5ml Normal saline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender, aged between 18 and 65 years.
2. Patients of American Society of Anesthesiology Grade I and II physical status.
3. Patients scheduled for elective infraumbilical surgery under spinal
anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients with known allergy to any of the study drugs.
2. All known contraindications to spinal anaesthesia like:
o Patients with coagulation disorders and on anticoagulants.
o Patients with local skin infection or disease.
o Patients with previous spinal surgeries, spine abnormalities.
3. Patient refusal. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the duration of sensory and motor block |
with in 24hrs postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need for rescue analgesia |
Till the effect of spinal analgesia subsides |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
15/06/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anaesthesia is one of the most common regional anesthetic techniques used for lower abdominal and lower limb surgeries. Levobupivacaine is a new long-acting local anesthetic agent.
Aims and Objectives: To evaluate duration of sensory block with intrathecal 0.5 % levobupivacaine and 25 µg fentanyl. To evaluate duration of sensory block with intrathecal 0.5% levobupivacaine and 250 µg butrophanol. To evaluate duration of sensory block with intrathecal 0.5% levobupivacaine and 0.5ml Normal saline. To compare the duration of sensory block of intrathecal 0.5% levobupivacaine with fentanyl vs butrophanol vs normal saline.
The present study will be conducted in the department of Anaesthesiology, G.G.S. Medical College, Faridkot on 180 patients. The patient will be divided into three groups of 60 each and the drug will be given as per group allocation. The aims of the study is to compare the effects of both the drugs on time and duration of sensory and motor block , maximum sensory level achieved, time to regression of sensory block till S2 dermatome and time to regression of motor block. The data will then be statistically analyzed. |