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CTRI Number  CTRI/2025/12/099191 [Registered on: 16/12/2025] Trial Registered Prospectively
Last Modified On: 15/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of dexmedetomidine versus nalbuphine added to intrathecal 0.5 percent isobaric levobupivacaine for anaesthesia in lower limb orthopedic surgeries 
Scientific Title of Study   Comparison of Effectiveness of Dexmedetomidine versus Nalbuphine as an Adjuvant with Intrathecal 0.5 Percent Isobaric Levobupivacaine in Lower Limb Orthopaedic Surgeries – A Randomized Double - Blind Controlled trial. 
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 Ashishkumar Rathwa 
Designation  Resident Doctor (MD Anaesthesiology) 
Affiliation  GMERS Medical College and Hospital, Gotri, Vadodara 
Address  6th floor, Department of Anaesthesiology, GMERS Medical College and Hospital, Gotri, Vadodara

Vadodara
GUJARAT
390021
India 
Phone  7203817256  
Fax    
Email  ashishrathva2501@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhavesh Dalwadi 
Designation  Professor HG, Department of Anesthesiology 
Affiliation  GMERS Medical College and Hospital, Gotri, Vadodara 
Address  6th floor, Department of Anaesthesiology, GMERS Medical College and Hospital, Gotri, Vadodara

Vadodara
GUJARAT
390021
India 
Phone  9825042148  
Fax    
Email  bhaveshkdalwadi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhavesh Dalwadi 
Designation  Professor HG, Department of Anesthesiology 
Affiliation  GMERS Medical College and Hospital, Gotri, Vadodara 
Address  6th floor, Department of Anaesthesiology, GMERS Medical College and Hospital, Gotri, Vadodara

Vadodara
GUJARAT
390021
India 
Phone  9825042148  
Fax    
Email  bhaveshkdalwadi@gmail.com  
 
Source of Monetary or Material Support  
GMERS medical college and hospital, Gotri,Vadodara, Gujarat, India-390021  
 
Primary Sponsor  
Name  GMERS medical college and hospital, gotri 
Address  GMERS medical college and hospital, gotri, vadodara, gujarat-390021 
Type of Sponsor  Government medical college 
 
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 Ashishkumar Rathva   GMERS medical college and hospital, Gotri,  6th floor department of anaesthesia, GMERS medical college and hospital, Gotri, Vadodara
Vadodara
GUJARAT 		 7203817256

ashishrathva2501@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intathecal Dexmedetomidine   0.5% Isobaric Levobupivacaine(3ml)+Dexmedetomidine 5 µg(0.05 ml drug from tuberculin syringe diluted in Distilled water (0.05ml) ) or Nalbuphine 1mg (0.1ml drug from tuberculin syringe) Under all aseptic and antiseptic precautions, patient placed in sitting position, in L3-L4 interspace, overlying skin will be anaesthetized by local infiltration with xylocaine 2%. After that subarachnoid block will be attempted with 23G Quincke spinal needle with midline approach and the total 3.1 ml of study drug will be injected after ensuring the free and clear flow of cerebrospinal fluid from the needle. Desirable level of spinal anaesthesia will be considered T10 The time of injection will be noted as Time “0” and assessment of sensory and motor characteristics of subarachnoid block will be done and vitals will be noted at every 2 minutes till 10 minutes, every 15 minutes till regression to S1 level of sensory block, every 30 minutes till Bromage “0”. Segmental level of sensory block to pin prick will be assessed by using a sterile hypodermic needle bilaterally along the midclavicular line.total duration is from time of onset of sensory and motor block till patient feel pain  
Comparator Agent  Intrathecal Nalbuphine  0.5% Isobaric Levobupivacaine(3ml)+ Nalbuphine 1mg (0.1ml drug from tuberculin syringe) Under all aseptic and antiseptic precautions, patient placed in sitting position, in L3-L4 interspace, overlying skin will be anaesthetized by local infiltration with xylocaine 2%. After that subarachnoid block will be attempted with 23G Quincke spinal needle with midline approach and the total 3.1 ml of study drug will be injected after ensuring the free and clear flow of cerebrospinal fluid from the needle. Desirable level of spinal anaesthesia will be considered T10 The time of injection will be noted as Time “0” and assessment of sensory and motor characteristics of subarachnoid block will be done and vitals will be noted at every 2 minutes till 10 minutes, every 15 minutes till regression to S1 level of sensory block, every 30 minutes till Bromage “0”. Segmental level of sensory block to pin prick will be assessed by using a sterile hypodermic needle bilaterally along the midclavicular line.total duration is from time of onset of sensory and motor block till patient feel pain 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA class I and II, BMI less than 35 kg per m2, elective orthopaedic below knee open surgeries. 
 
ExclusionCriteria 
Details  patient refusal, coagulation, pregnancy, deformity of vertebral column, allergy to study drug, psychiatric or neurologic illnesses. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
onset of sensory and motor block  onset of sensory and motor block from time of intrathecal drug injection  
 
Secondary Outcome  
Outcome  TimePoints 
duration of sensory & motor block  from intrathecal injection to regression of sensory block to s1 dermatome & recovery of motor function(bromage score 0) 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   12/01/2026 
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)   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  
All patients will be kept fasting for 6 hours prior to surgery.In the operating room, each patient will be identified and then placed on a operating table, routine non-invasive monitor will be applied. Baseline pulse rate, ECG, respiratory rate, blood pressure (SBP and DBP) and oxygen saturation will be recorded Intravenous access will be gained using 18G venous catheter and preloading will be done with 10mL/kg Ringer Lactate solution within 20 minutes of procedure. Premedication inj. Ondansetron 0.08mg/kg IV will be given before the administration of spinal Anaesthesia. All equipment and drugs necessary for resuscitation and general Anaesthesia will be kept ready. One member of the team (other than PI and Co-PI) will be assigned to prepare the drug under aseptic precautions as per the group while the anaesthesiologist performing the block and the patient, both will be unaware about the drug. Study drug : 0.5% Isobaric Levobupivacaine(3ml)+Dexmedetomidine 5 µg(0.05 ml drug from tuberculin syringe diluted in Distilled water (0.05ml) ) or Nalbuphine 1mg (0.1ml drug from tuberculin syringe). Under all aseptic and antiseptic precautions, patient placed in sitting position, in  L3-L4 interspace, overlying skin will be anaesthetized by  local infiltration with  xylocaine 2%. After that subarachnoid block will be attempted with 23G Quincke spinal needle with midline approach and the total 3.1 ml of study drug will be injected after ensuring the free and clear flow of cerebrospinal fluid from the needle. Desirable level of spinal anaesthesia will be considered T10. After injection of drug, patient will be immediately turned supine. All patients will be given supplemental oxygen by Nasal prong  at the flow rate of 2L/min. The time of injection will be noted as Time “0” and assessment of sensory and motor characteristics of subarachnoid block will be done and  vitals will be noted at every 2 minutes till 10 minutes, every 15 minutes till regression to S1 level of sensory block, every 30 minutes till Bromage “0”.Segmental level of sensory block to pin prick will be assessed by using a sterile hypodermic needle bilaterally along the midclavicular line. 
 
 
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