| CTRI Number |
CTRI/2025/07/091587 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| 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
|
A comparative study between epidural nalbuphine and fentanyl for analgesic efficacy in patients undergoing infraumbilical surgeries under spinal anesthesia |
|
Scientific Title of Study
|
A comparative study of epidural nalbuphine versus fentanyl for analgesic efficacy in patients undergoing infraumbilical surgeries under spinal anesthesia. |
| 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 Varshini G |
| Designation |
Post graduate student |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anesthetia, bangalore medical College and research institute,fort, K R road, bangalore
Department of anesthetia Bangalore medical college and research institute,fort, K.R road, 560002
Bangalore
KARNATAKA
562105
India |
| Phone |
7892051604 |
| Fax |
|
| Email |
vasudha49varshini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nethra SS |
| Designation |
Head of the department |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anesthetia Bangalore medical college and research institute,fort, K.R road, Bangalore
Bangalore medical college and research institute,fort, K.R road, Bangalore,560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9448171403 |
| Fax |
|
| Email |
nethra.surhonne@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nethra SS |
| Designation |
Head of the department |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anesthetia Bangalore medical college and research institute,fort, K.R road, Bangalore
Department of anesthetia Bangalore medical college and research institute,fort, K.R road, Bangalore,560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9448171403 |
| Fax |
|
| Email |
nethra.surhonne@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Varshini G |
| Address |
Bangalore medical college and research institute, fort, K.R road, Bangalore 560002 |
| 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 |
| Dr Varshini G |
Bangalore medical college and research institute |
Department of anesthesiology, Bangalore medical college and research institute, fort, K.R road, Bangalore
Bangalore
KARNATAKA |
7892051604
vasudha49varshini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute |
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 |
Fentanyl 50mcg |
Epidural fentanyl 50mcg with 0.125 %bupivacaine diluted to 9ml normal saline |
| Intervention |
Nalbuphine |
Epidural nalbuphine 5mg with 0.125 %bupivacaine diluted to 9ml normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving consent, ASA grade 1 and 2, BMI 18 to 29 kg/m^2 |
|
| ExclusionCriteria |
| Details |
Allergy to local anesthetic, spine deformity, coagulopathy,chronic pain syndromes, cardiac diseases, liver and kidney dysfunction, neurological disorders, pregnancy and breastfeeding mothers, technical failure, patients on tricyclic antidepressants, alpha 2 agonist and opioids |
|
|
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 |
| Analgesic efficacy of epidural nalbuphine versus fentanyl in terms of duration of Analgesia in patients undergoing infraumbilical surgeries under spinal anesthesia in 24 hours |
Analgesic efficacy of epidural nalbuphine versus fentanyl in terms of duration of Analgesia in patients undergoing infraumbilical surgeries under spinal anesthesia in 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare onset of sensory & motor blockade, duration of motor blockade, 2 segment regression, VAS, ramsay sedation scale, time of first rescue analgesia. |
In 24 hrs |
| Assess hemodynamic parameters perioperatively |
24 hours |
| Assess incidence of any side effects of study drugs |
In 24 hours |
|
|
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)
|
01/10/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a randomized control, double blinded study, comparing the analgesic efficacy of epidural nalbuphine 5mg versus fentanyl 50 mcg in patients undergoing infraumbilical surgeries under spinal anesthesia that will be conducted in bangalore medical college and research institute and the allied hospitals. The primary outcome is to compare the analgesic efficacy and secondary outcome is to assess the onset of sensory and motor blockade, duration of motor blockade, 2 segment regression, VAS scores, ramsay sedation scores and time for first rescue analgesic. |