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CTRI Number  CTRI/2024/07/070200 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the duration of pain relief with clonidine and morphine added to local anaesthetic drug Bupivacaine in spinal anaesthesia for patients undergoing vaginal hysterectomy. 
Scientific Title of Study   Randomized, double blinded clinical trial to evaluate efficacy of intrathecal clonidine and intrathecal morphine as adjuvants to hyperbaric bupivacaine in spinal anaesthesia for patients undergoing vaginal hysterectomy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajesh Ravi 
Designation  Junior Resident 
Affiliation  Christian Medical College 
Address  Department of Anaesthesiology, Christian Medical College, Vellore, Tamilnadu, India Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9486027872  
Fax    
Email  dr.rrajesh92@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anita Shirley 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Anaesthesiology, Christian Medical College, Vellore, Tamilnadu, India Vellore

Vellore
TAMIL NADU
632004
India 
Phone  7358377164  
Fax    
Email  anjeyanth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anita Shirley 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Anaesthesiology, Christian Medical College, Vellore,

Vellore
TAMIL NADU
632004
India 
Phone  7358377164  
Fax    
Email  anjeyanth@gmail.com  
 
Source of Monetary or Material Support  
Fluid research grant , Christian medical college , Vellore -632004. 
 
Primary Sponsor  
Name  Rajesh Ravi 
Address  Department of Anaesthesiology, Christian Medical College, Vellore, Tamilnadu, India Vellore TAMIL NADU 632004 India 
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 Rajesh Ravi  Christian Medical College  Operating room, Department of Anaesthesiology.
Vellore
TAMIL NADU 
9486027872

dr.rrajesh92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insstitutional Review Board and Ethics Committee of CMC Vellore  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  Clonidine  Dose - 0.1 micrograms per kilogram of body weight Route - Intrathecal Frequency - once before the start of surgery and will be observed for 24 hours 
Comparator Agent  Morphine  Dose - 1 to 2 micrograms per kilogram of body weight Route - Intrathecal Frequency - once before the start of surgery and will be observed for 24 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  undergoing Vaginal hysterectomy under spinal anesthesia  
 
ExclusionCriteria 
Details  Patients who have contraindications for regional anaesthesia will be excluded from the study 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of postoperative analgesic effect of intrathecal clonidine and morphine when used as adjuvants to hyperbaric bupivacaine in spinal anaesthesia  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare postoperative pain scores in both groups.

2. To compare side effects like sedation, bradycardia, hypotension, urinary retention, nausea, vomiting, Itching, dry mouth and post operative shivering.

3. Time to regression of motor or sensory block

4. Time to first oral intake

5. Patient satisfaction scores
 
24 hours 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   19/07/2024 
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="0"
Months="8"
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  

Healthy female patients, 18 years of age and older, who are undergoing vaginal hysterectomy under spinal anesthesia will be included in the study after IRB approval and CTRI registration. Patients will be informed about the anesthesia plan and will provide written informed consent a day before the surgery. Patients with contraindications for regional anesthesia will be excluded from the study. The participants will be randomly assigned to two groups. The control group will receive a subarachnoid block with heavy Bupivacaine 0.5% and intrathecal morphine 2 mcg/kg, according to the standard of care in our institution. Patients in the study group will receive a subarachnoid block with heavy Bupivacaine 0.5% and intrathecal clonidine 1 mcg/kg. Both groups will receive the same intraoperative monitoring of vital signs, IV fluids, and anti-emetic medications. The duration of analgesic effect will be measured from the time of spinal administration to the first analgesic request in the postoperative period. The time to regression of motor and sensory blocks will be assessed. Postoperative pain scores, side effects, time to first oral intake, and patient satisfaction scores will be recorded for both groups.

 
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