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CTRI Number  CTRI/2023/12/060752 [Registered on: 26/12/2023] Trial Registered Prospectively
Last Modified On: 22/12/2023
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   In patients undergoing gynaecological surgeries, a comparison will be done between levobupivacaine with nalbuphine and fentanyl for post-operative analgesia administered during spinal anesthesia.  
Scientific Title of Study   Comparision of Post Operative Analgesia Between Nalbuphine and Fentanyl as adjuvant with intrathecal Levobupivacaine for lower abdominal Gynaecological 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  Saely Shekhar Paunikar 
Designation  Junior Resident,  
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of anaesthesia Jawaharlal Nehru Medical College
Sawangi(Meghe)
Wardha
MAHARASHTRA
442001
India 
Phone  9892132765  
Fax    
Email  saely21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjot Ninave 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of anaesthesia Jawaharlal Nehru Medical College
Sawangi(Meghe)
Wardha
MAHARASHTRA
442001
India 
Phone    
Fax    
Email  drsusann02@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Saely Shekhar Paunikar 
Designation  Junior Resident,  
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of anaesthesia Jawaharlal Nehru Medical College
Sawangi(Meghe)

MAHARASHTRA
442001
India 
Phone  9892132765  
Fax    
Email  saely21@gmail.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  Jwaharlal Nehru Medical College 
Address  Department of Anaesthesia Datta Meghe Institute of Higher Education and Research 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Saely Paunikar  Acharya Vinoba Bhave Rural Hospital  Department of Anaethesia, AVBRH, Jawaharlal Nehru Medical College
Wardha
MAHARASHTRA 
9892132765

saely21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: N888||Other specified noninflammatory disorders of cervix uteri,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fentanyl 12.5 mcg intrathecal  post operative analgesia will be assessed between fentanyl and nalbuphine with levobupivacaine till 180 mins 
Intervention  Nalbuphine 1mg intrathecal   post operative analgesia will be assessed between fentanyl and nalbuphine with levobupivacaine till 180 mins 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1 Age between 35-75 years
2 Lower Abdominal surgeries under Subarachnoid Block
3 Duration of Surgery 2 hours
4 ASA I & II
5 MPC I & II
6 Patients willing to participate in the study
 
 
ExclusionCriteria 
Details  1 Lack of valid informed written consent
2 ASA grade III and IV
3 Infection at the subarachnoid block injection site
4 Patients with neurological and musculoskeletal disease
5 Patients with bleeding disorders
6 Patients on anticoagulants
7 History of allergy to local anesthetic, Fentanyl and Nalbuphine
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
We are trying to prove the hypothesis that addition of adjuvant 1 mg Inj.Nalbuphine intrathecally to Hyperbaric Levobupivacaine prolongs the duration of post-operative analgesia more as compared 25mcg Inj.Fentanyl intrathecally with hyperbaric levobupivacaine  post operative analgesia will be assessed as the primary outcome and it will be monitored for 2 hrs post spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/01/2024 
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="4"
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 has a rapid onset and complete motor blockade  and also simple to perform. It has lower incidence of failed block and the local anaesthetic requirement is less. Hence spinal anesthesia is a preferred anaesthetic technique for lower abdominal surgeries. Adjuvants to local anaesthetics for intrathecal administration has some advantages. They have synergistic action & intensify sensory block without increasing sympathetic block, reduced local anaesthetic drug dose, better hemodynamic stability with lesser side effects.

Fentanyl is a pure mu receptor agonist. The common mu agonist side effects are  nausea, vomiting, sedation, urinary retention and respiratory depression. It is lipophilic in nature, with rapid onset of action following intrathecal administration. The intrathecal drug administration does not produce respiratory depression. It improves anaesthetic quality without much complications.  Nalbuphine is a mixed kappa agonist and mu antagonist opioid drug, which produces analgesia without much side effects of mu receptor agonist action.

Levobupivacaine is a local anaesthetic amide which can produce better sensory and motor block with good hemodynamic profile than bupivacaine. Levobupivacaine is less cardiotoxic than bupivacaine. (1) Many investigators have studied the characteristics of intrathecal nalbuphine & fentanyl with levobupivacaine.

The purpose of this study is to compare the efficacy of fentanyl & nalbuphine as adjuvants to intrathecal levobupivacaine for post-operative analgesia following lower abdominal gynaecological surgeries. 
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