| CTRI Number |
CTRI/2022/03/040873 [Registered on: 07/03/2022] Trial Registered Prospectively |
| Last Modified On: |
15/09/2022 |
| 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
|
Comparison of spinal anaesthesia using bupivacaine with fentanyl to spinal anaesthesia using levobupivacaine with fentanyl for transurethral resection of prostate |
|
Scientific Title of Study
|
Comparison of intrathecal bupivacaine with levobupivacaine using fentanyl as an adjuvant for transurethral resection of prostate |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Indira Malik |
| Designation |
Assistant professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of cardiac anaesthesia
Room no 3, 1st floor, Lala Shyamlal building
PGIMS Rohtak
Rohtak
HARYANA
124021
India |
| Phone |
9350224435 |
| Fax |
|
| Email |
mdr.indira@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Indira Malik |
| Designation |
Assistant professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of cardiac anaesthesia
Room no 3, 1st floor, Lala Shyamlal building
PGIMS Rohtak
Rohtak
HARYANA
124021
India |
| Phone |
9350224435 |
| Fax |
|
| Email |
mdr.indira@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Sheenam Kamboj |
| Designation |
PG student |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Anaesthesiology and critical care
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8168946647 |
| Fax |
|
| Email |
sheenamkamboj98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt BD Sharma, PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Deptt of anaesthesia PGIMS Rohtak |
| Address |
PGIMS Rohtak |
| Type of Sponsor |
Government 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 |
| dr indira malik |
PGIMS Rohtak |
Department of anaesthesiology
2nd floor, Modular OT Complex
Rohtak
HARYANA |
9350224435
mdr.indira@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
bupivacaine with fentanyl |
bupivacaine hyperbaric 12.5 mg with fentanyl 25 microgm mixed together single shot, intrathecally, duration of procedure 1-2 hr |
| Intervention |
intrathecal levobupivacaine with fentanyl |
intrathecal levobupivacaine isobaric 12.5 mg with fentanyl 25 microgm mixed together single shot by intrathecal route, duration of procedure 1-2 hr |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Male patients undergoing TURP |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Local site infection
3. Bleeding disorders
4. Disease of spinal cord, central nervous system
5. Allergy to study drugs |
|
|
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 |
time to onset of sensory and motor block in both groups
regression of sensory block by 2 segments and complete regression of motor block
time to first rescue analgesia |
time to onset of sensory and motor block in both groups
regression of sensory block by 2 segments and complete regression of motor block
time to first rescue analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic parameters- heart rate, syatolic BP, diastolic BP, mean arterial pressure
need for postoperative analgesia
any complications/adverse effects- bradycardia, hypotension, nausea, vomiting, shivering |
every 5 min |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/03/2022 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This trial aims to study the efficacy of intrathecal bupivacaine and compare it with levobupivacaine using fentanyl as an adjuvant in both the groups in patients aged 50-80 years, undergoing transurethral resection of prostate (TURP). We will compare the onset of sensory and motor block, time to 2 segment regression of sensory and complete regression of motor block, time to first rescue analgesia, any complications and adverse effects in the 2 groups |