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CTRI Number  CTRI/2024/01/062089 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 30/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Nalbuphine vs fentanyl as additive to main drug bupivacaine in spinal anaesthesia. 
Scientific Title of Study   Comparison of intrathecal nalbuphine and fentanyl as adjuvants to bupivacaine in spinal anaesthesia in patients undergoing lower limb 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 Virendra Nimbalkar 
Designation  Post graduate trainee 
Affiliation  Silchar medical college and hospital 
Address  Department of anesthesia and critical care, Silchar medical college and hospital, Silchar.

Cachar
ASSAM
788014
India 
Phone  9673240044  
Fax    
Email  virunimbalkar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suneeta Dutta 
Designation  Head of department 
Affiliation  Silchar medical college and hospital 
Address  Department of anesthesia and critical care, Silchar medical college and hospital, Silchar.

Cachar
ASSAM
788014
India 
Phone  9435074110  
Fax    
Email  drsuneetadutta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suneeta Dutta 
Designation  Head of department 
Affiliation  Silchar medical college and hospital 
Address  Department of anesthesia and critical care, Silchar medical college and hospital, Silchar.

Cachar
ASSAM
788014
India 
Phone  9435074110  
Fax    
Email  drsuneetadutta@gmail.com  
 
Source of Monetary or Material Support  
Silchar medical college and hospital, Silchar, Cachar, Assam Pin-788014 
 
Primary Sponsor  
Name  Dr Virendra Nimbalkar 
Address  Department of anesthesia and critical care, Silchar medical college and hospital, Silchar,788014 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Virendra Nimbalkar  Silchar medical college and hospital  Orthopedics department
Cachar
ASSAM 		 9673240044

virunimbalkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Silchar Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy patients undergoing lower limb surgeries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intrathecal fentanyl as adjuvants to heavy bupivacaine in spinal anesthesia in patients undergoing lower limb surgeries.  The solution will be prepared in a five ml syringe which will contain, a) 3ml(15mg)of 0.5% Bupivacaine heavy+0.5ml fentanyl(25µg).The above combination of drugs was given via intrathecal subarachnoid route with the patient in standard sitting position with a 25Gauge Quincke needle at L3-L4 intervertebral space using midline approach maintaining strict aseptic condition.Taking into consideration the time of spinal injection as zero, all other durations were calculated accordingly and all measurements will be recorded from this point upto 3 hours postop . Following subarachnoid block, patients will be made to lie supine. 
Intervention  Intrathecal nalbuphine as adjuvants to heavy bupivacaine in spinal anesthesia in patients undergoing lower limb surgeries.  The solution will be prepared in a five ml syringe which will contain, a) 3ml(15mg)of 0.5% Bupivacaine heavy+0.5ml Nalbuphine(0.5mg).The above combination of drugs was given via intrathecal subarachnoid route with the patient in standard sitting position with a 25Gauge Quincke needle at L3-L4 intervertebral space using midline approach maintaining strict aseptic condition. Taking into consideration the time of spinal injection as zero, all other durations were calculated accordingly and all measurements will be recorded from this point up to 3 hours postop. Following subarachnoid block, patients will be made to lie supine. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.American society of anaesthesiologist(ASA) status I and II
2.Age 25-65 years
3.both genders.  
 
ExclusionCriteria 
Details  1.Patients with contraindication to spinal anaesthesia
2.Pre-existing neurological deficits
3.Patients with history of allergy to study drugs
4.Pregnant patients. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate & compare the following factors in
two groups-intrathecal nalbuphine &
intrathecal fentanyl as an adjuvant to
hyperbaric bupivacaine in lower limb
surgeries with respect to:
1. Sensory & motor blockade -onset & duration 		 Time at which intrathecal drug is administered is
T0, followed by T1 at 1min,T2 at 2 min,T3 at 3 min interval......till intraoperative period followed
by time required for regaining of sensory and
motor sensation in postoperative period. 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of analgesia  perioperative to postoperative period 
 
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   Phase 2 
Date of First Enrollment (India)   09/02/2024 
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="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  

      Spinal anesthesia remains a popular method of anesthesia for a wide range of surgeries due  to its easiness ,safety features and newer addition drugs with less side effects and more benefits for certain patient populations. However, it is also frequently associated with undesirable effects such as hypotension, bradycardia, and shivering. Rarely, it may cause severe bradycardia and cardiac arrest. Adjuvants or additives are often used with local anesthetics for its synergistic effect by prolonging the duration of sensory-motor block, minimize side effects and limiting the cumulative dose requirement of local anesthetics.

      Opioids are the time honoured drugs which have been used for this purpose. Nalbuphine is an agonist-antagonist opioid synthesized to produce analgesia without any unwanted µ agonist side effects like respiratory depression, undesirable sedation, nausea, vomiting and urinary retention.

Fentanyl, a synthetic opioid, has fast onset of action following intrathecal administration due to its high lipid soluble nature. It does not tend to migrate to the fourth ventricle in sufficient concentration to cause delayed respiratory depression when administered intrathecally. In this study. Adjuvants are added to prolong post operative analgesia to increase duration of analgesia and to limit the side effects of increased dose of local anesthetics on hemodynamics.

 
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