| CTRI Number |
CTRI/2025/01/079600 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to compare the effect of nalbuphine and fentanyl as an additive to Hyperbaric bupivacaine intrathecally to compare intra-OT hemodynamic response , Duration of Sensory and Motor onset, duration of Sensory and Motor blockade and Duration of analgesia |
|
Scientific Title of Study
|
A COMPARATIVE STUDY BETWEEN INTRATHECAL HYPERBARIC BUPIVACAINE 0.5 percent 3.0cc WITH NALBUPHINE 0.4 MILLIGRAM VERSUS HYPERBARIC BUPIVACAINE 0.5 percent 3.0 CC WITH FETANYL 25 MICROGRAM IN INFRAUMBILICAL SURGERIES |
| 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 Kartik H Sangam |
| Designation |
Resident Doctor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre |
| Address |
Anaesthesia Department, General OT complex, 2nd Floor Dhiraj Hsopital, Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre, Waghodia , Piparia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
08767272524 |
| Fax |
|
| Email |
kartik.svdu2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh Shah |
| Designation |
Professor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre |
| Address |
Anaesthesia Department, General OT complex, 2nd Floor Dhiraj Hsopital, Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre, Waghodia , Piparia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9825038233 |
| Fax |
|
| Email |
nileshshah730@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilesh Shah |
| Designation |
Professor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre |
| Address |
Anaesthesia Department, General OT complex, 2nd Floor Dhiraj Hsopital, Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre, Waghodia , Piparia, Vadodara
GUJARAT
391760
India |
| Phone |
9825038233 |
| Fax |
|
| Email |
nileshshah730@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre
Piparia
Waghodia
Vadodara, Gujarat-391760
India |
|
|
Primary Sponsor
|
| Name |
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre |
| Address |
Waghodia, Pipariya, vadodara, Gujarat, india- 391760 |
| Type of Sponsor |
Private 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 Kartik H Sangam |
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre |
Anaesthesia Department, General OT complex, 2nd Floor Dhiraj Hsopital, Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre, Waghodia , Piparia, Vadodara
Vadodara
GUJARAT |
9082625612
kartik.svdu2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (2) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified, (3) ICD-10 Condition: N350||Post-traumatic urethral stricture, (4) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (5) ICD-10 Condition: M173||Unilateral post-traumatic osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INJ. FENTANYL 25 MCG INTRATHECALLY |
INJ. FENTANYL 25 MCG INTRATHECALLY AS AN ADDITIVE TO INJ. BUPIVACAINE HYPERBARIC 3.0cc
Dose - 25mcg (0.5cc)
Route - intrathecally
Duration - Till admistration of Rescue analgesia
|
| Comparator Agent |
INJ. NALBUPHINE 0.4 MG INTRATHECALLY |
INJ. NALBUPHINE O.4 MG INTRATHECALLY AS AN ADDITIVE TO INJ. BUPIVACAINE HYPERBARIC
3.0cc
Dose - 0.4 mg ( 0.04cc)
As a diluent add sterile NS - 0.46 cc
Route - Intrathecally
Duration - Till Admistration of Rescue analgesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients are willing to sign the informed written consent.
Patients of ASA Grade I and II of either gender.
Under Spinal anaesthesia for elective BELOW UMBILICAL SURGERIES
Age 20 - 60 years.
No known history of allergy or sensitivity to local
anaesthetics of the amide group and other drugs used for this study |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Patient not NIL by mouth.
History of seizure disorder.
Known allergy to trial drugs.
Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction.
ASA III, IV, V Patients.
Patients with prior pre-existing Comorbidities (Heart diseases, Respiratory diseases, Kidney diseases, known fetal abnormalities) Pregnant females
Failed spinal anaesthesia converted to general anaesthesia.
Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities. Patients fulfilling the above inclusion criteria are taken for study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| This study aims to compare the efficacy of Fentanyl and nalbuphine used as an additive to bupivacaine in subarachnoid block to compare the hemodynamic response in infra-umbilical surgeries |
Hemodynamic response and Onset of Sensory and motor blockade asseses at
Baseline
2min
5 mins
10 mins
15 mins
20 mins
30 mins
45 mins
60 mins
90 mins
120 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare duration of Post-operative analgesia in group fentanyl & group nalbuphine |
Post-operative Anaglesia
Baseline Vas Score
At 4 hours
6 hours
8 hours
12 hours
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/02/2025 |
| Date of Study Completion (India) |
10/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
THE PURPOSE OF THE STUDY IS TO COMPARE THE HEMODYNAMIC VARIABLE AND POST-OPERATIVE ANAGLESIA IN PATIENTS RECEIVING INTRA-THECAL NALBUPHINE AND FENTANYL AS AN ADDITIVE TO HYPERBARIC BUPIVACAINE IN BELOW UMBILICAL SURGRIES.
AIM:
Aim of this study is to compare the efficacy of Fentanyl and nalbuphine used as additive to bupivacaine in subarachnoid block in infraumbilical surgeries
Objectives:
TO COMPARE ONSET OF SENSORY AND MOTOR BLOCKADE TO COMPARE DURATION OF SENSORY AND MOTOR BLOCKADE COMPARE SEDATION OF PATIENT TO COMPARE THE HAEMODYNAMIC CHANGES IN (PULSE RATE, BLOOD PRESSURE, OXYGEN SATURATION AND RESPIRATORY RATE) TO COMPARE DURATION OF ABSOLUTE ANALGESIA AND EFFECTIVE ANALGESIA TO COMPARE THE REQUIREMENT OF NUMBER OF RESCUE ANALGESIA TO COMPARE THE SIDE EFFECTS/COMPLICATIONS IF any
Inclusion Criteria: ◠Patients willing to sign the informed written consent. ◠Patients of ASA Grade I and II of either gender. ◠Under Spinal anaesthesia for elective lower limb surgeries ◠Aged 18 - 60 years. ◠No known history of allergy, sensitivity to local anaesthetics of the amide group and other drugs used for this study. Exclusion Criteria: ‘◠Patient refusal. ◠Patient not NIL by mouth. ◠History of seizure disorder. ◠Known allergy to trial drugs. ◠Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction. ◠ASA III, IV, V Patients. ◠Patient with prior pre-existing Comorbidities (Heart diseases, Respiratory disease, Kidney diseases , known fetal abnormalities) ◠Pregnant females ◠Failed spinal anaesthesia converted to general anaesthesia ◠Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities. Patients fulfilling above inclusion criteria are taken for study.
Method
After obtaining written informed consent, 60 patients planned for elective surgeries will be enrolled and grouped into Group-F & Group-N with 30 patients in each group.
|