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CTRI Number  CTRI/2023/10/058853 [Registered on: 19/10/2023] Trial Registered Prospectively
Last Modified On: 18/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of addition of clonidine or fentanyl to spinal 0.75% hyperbaric(heavy) ropivacaine in lower limb surgeries.  
Scientific Title of Study   Effect of addition of clonidine or fentanyl to intrathecal 0.75% hyperbaric ropivacaine in lower limb surgeries:- A randomized controlled clinical study.  
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 Deepak Kumar 
Designation  Post Graduate Resident 
Affiliation  Maharaja Agrasen Medical College Agroha, Hisar, Haryana  
Address  Department of Anaesthesia Maharaja Agrasen Medical College Agroha, Hisar, Haryana

Hisar
HARYANA
125047
India 
Phone  9416304998  
Fax    
Email  deepakkamboj1984@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sheetal 
Designation  Professor  
Affiliation  Maharaja Agrasen Medical College Agroha, Hisar, Haryana  
Address  Department of Anaesthesia Maharaja Agrasen Medical College Agroha, Hisar, Haryana

Hisar
HARYANA
125047
India 
Phone  8950426301  
Fax    
Email  sheetalbhatia1234@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rishabh 
Designation  Assistant Professor  
Affiliation  Maharaja Agrasen Medical College Agroha, Hisar, Haryana  
Address  Department of Anaesthesia Maharaja Agrasen Medical College Agroha, Hisar, Haryana

Hisar
HARYANA
125047
India 
Phone  8130449525  
Fax    
Email  agarwalrishabh66@gmail.com  
 
Source of Monetary or Material Support  
Maharaja agrasen medical college agroha, hisar, Haryana  
 
Primary Sponsor  
Name  Dr Deepak Kumar 
Address  Maharaja Agrasen Medical College Agroha, Hisar, Haryana  
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 Deepak Kumar   Maharaja Agrasen Medical College Agroha, Hisar, Haryana  Department of Anaesthesia, Maharaja Agrasen Medical College Agroha, Hisar, Haryana pin- 125047
Hisar
HARYANA 		 9416304998

deepakkamboj1984@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Reserch, Maharaja Agrasen Medical College, Agroha Hisar Haryana  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 
Comparator Agent  Inj ropivacaine(0.75% hyperbaric) + Inj clonidine.  2.5ml of 0.75% hyperbaric ropivacaine + 15 mcg clonidine (0.1 ml) ) + 0.4 ml normal saline-total volume 3.0 ml for intrathecal block. 
Intervention  Inj ropivacaine(0.75% hyperbaric) + Inj fentanyl.  2.5ml of 0.75% hyperbaric ropivacaine + 25 mcg fentanyl (0.5 ml) for intrathecal block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adult patients of either sex, aged between 18-60 years age.
2. American Society of Anaesthesiologists (ASA) I and II status
 
 
ExclusionCriteria 
Details  1. Patient’s refusal for the procedure
2. Known drug allergy
3. Pregnant patient
4. Body mass index ≥30 kg/m2
5. Spine/ Neurological or coagulation disorders.
6. Patients with known cardio respiratory diseases.
7. Duration of surgery less than 60 min
 
 
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 
1.To determine the duration of sensory & motor block.
2.To determine time of 1st rescue analgesia.
 		 1.Duration of sensory block is measured from Time of onset of sensory block to regression at S1.
Duration of motor block is measured from Time of onset of motor block to complete recovery i.e. Bromage 0.
2.Time of administration of first rescue analgesia is measured from Time of onset of sensory block to demand of first analgesia and/ or VAS 3 in PACU/Ward. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine Onset of sensory & motor block.
2.To determine Haemodynamic changes.
3.To determine Side effects if any.  		 1.Onset of sensory block is measured from Time of intrathecal injection to sensory loss at S1. &
Onset of motor block is measured from Time of intrathecal injection till Bromage scale 3.
2.Incidence of hemodynamic changes such as hypotension, bradycardia during intra-operative period
3.side effects. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   28/10/2023 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [deepakkamboj1984@gmail.com].

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 01-12-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

To compare the effects of Fentanyl and Clonidine as adjuvant to  0.75% hyperbaric Ropivacaine on duration of intrathecal block .                                                                                                     

Objective:-

Primary

1.     To determine the duration of sensory and motor block.

2.     To determine time of 1st rescue analgesia.

Secondary

1.     To determine Onset of sensory and motor block.

2.     To determine Haemodynamic changes.

3.     To determine Side effects if any.   

Group allocation-The patients undergoing elective lower limb surgeries will be divided   into one of the two groups of 40 each

Group-RF (40)-2.5ml of 0.75% hyperbaric ropivacaine + 25 mcg fentanyl (0.5 ml) =total volume 3.0 ml Group-RC (40)-2.5ml of 0.75% hyperbaric ropivacaine + 15 mcg clonidine (0.1 ml)+ 0.4 ml normal saline= total volume 3.0 ml.

Study drug will be prepared by first anaesthesiologist in a sterile unlabelled syringe according to group allocation. Under all aseptic precautions, lumbar puncture will be performed in L2–L3/L3–L4 inter vertebral space in sitting position using a 25G Quincke’s spinal needle and study drug will be injected by the second anaesthesiologist who will remain blinded to composition of drug.. Time of intrathecal injection will be noted. Continuous Monitoring of the BP, HR, SpO2, and ECG will be done.

Sensory block will be assessed by the loss of sensation to pinprick using a 25G blunt needle along the mid-axillary line bilaterally every 2 min till two consecutive readings remain the same i.e., highest cephalad spread of sensory block has occurred. The time of sensory block at T12 will be noted as onset of sensory block and the surgeon will be allowed to start the surgery. Regression of sensory block till S1 will be noted as duration of sensory block. Time of 1st rescue analgesia will be determined from the time of onset of sensory block till patient demands the first rescue analgesic and/ or VAS > 3 in post-anaesthesia care unit. Visual Analogue Scale (VAS) is used, wherein 0=no pain, and 10=severe pain every 15 minutes in the post anaestheia care unit. Rescue analgesia will be given with Inj. Diclofenac 75 mg iv infision. 

Motor block will be assessed according to Bromage scale i.e., Bromage 0: Patients able to move hip, knee, and ankle, Bromage 1: Patients unable to move hip but able to move the knee and ankle, Bromage 2: Patient unable to move hip and knee but able to move the ankle, Bromage 3: Patient unable to move hip, knee, and ankle. Motor block will be accessed every 2 minute interval. Onset of maximum motor block is defined as the time from intrathecal injection of the drug to attain Bromage scale 3. Duration of motor block is defined as the time taken from the onset of motor block to complete recovery of motor block i.e. Bromage score of 0. Complications such as hypotension, bradycardia, nausea, vomiting, shivering, pruritus if any, in the intra-operative as well as postoperative period will be noted in a prepared Proforma and will be managed accordingly.                                     

Following parameters will be observed:

1.  Demographic parameters: Age, gender, weight, height, BMI and duration of surgery.

2.  Study parameters

1.     Onset of sensory block: Time from intrathecal injection to sensory loss at T12. 

2.     Duration of sensory block: Time from onset of sensory block to regression at S1.

3.     Time of administration of first rescue analgesia: Time from onset of sensory block to demand of first analgesia and/ or VAS > 3 in PACU/Ward.

4.     Onset of motor block: Time from intrathecal injection till Bromage scale 3.

5.     Duration of motor block: Time from onset of motor block to complete recovery i.e. Bromage 0.

6.     Incidence of hemodynamic changes such as hypotension, bradycardia and other side effects.   

 
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