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CTRI Number  CTRI/2023/01/049068 [Registered on: 17/01/2023] Trial Registered Prospectively
Last Modified On: 26/02/2023
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   comparison of intrathecal morphine versus Erector spinae plane block for postoperative pain control in patients with Kidney Disease undergoing kidney Transplantation 
Scientific Title of Study   A clinical comparison of intrathecal morphine versus Erector spinae plane block for postoperative pain control in patients with End Stage Kidney Disease undergoing kidney Transplantation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  saurabh mittal 
Designation  DM Resident 
Affiliation  MAHATMA GANDHI HOSPITAL  
Address  dept. of organ transplant anaesthesia and critical care

Jaipur
RAJASTHAN
302022
India 
Phone    
Fax    
Email  saurabh.mittal013@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vipin kumar goyal 
Designation  Prof. and H.O.D 
Affiliation  mahatma gandhi hospital 
Address  dept. of organ transplant anaesthesia and critical care

Jaipur
RAJASTHAN
302022
India 
Phone    
Fax    
Email  dr.vipin28@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vipin kumar goyal 
Designation  Prof. and H.O.D 
Affiliation  mahatma gandhi hospital 
Address  dept. of organ transplant anaesthesia and critical care


RAJASTHAN
302022
India 
Phone    
Fax    
Email  dr.vipin28@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Hospital 
 
Primary Sponsor  
Name  Mahatma gandhi hospital 
Address  sitapura,tonk road, jaipur, pin-302022 
Type of Sponsor  Private 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 
saurabh mittal  Mahatma gandhi hospital  Department of Organ transplant anaesthesia and critical care ,tonk road pin-302022
Jaipur
RAJASTHAN 
8087439644

saurabh.mittal013@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  sabarachnoid block  In group M patients after thorough hand washing and wearing personal protective equipment’s, patients back will be cleaned and draped under all aseptic precautions as per the standard operating procedure protocol. With patient in sitting position, intervertebral space L3-L4 is palpated. A 25 G Quincke needle will be inserted and after confirmation of free flow of CSF, a total volume of 2 ml (200 mcg (0.2ml) morphine along with 1.8 ml normal saline) is injected. 
Comparator Agent  usg guided erector spinae plane block  in group E, patients will be given unilateral ultrasound guided erector spinae block with 20 ml of 0.5 % ropivacaine after induction of general anaesthesia following the same standard operating procedure protocol.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 American Society of Anaesthesiologists (ASA) III patients
2 Age group of 20-60 years
3 Patient with written valid consent
4 Patient undergoing renal transplant surgery.

 
 
ExclusionCriteria 
Details  1 Patient refusal
2 History of allergy to study drug

3 Contraindication to spinal puncture/regional block (e.g. bleeding diathesis, neurologic dysfunction, and recent systemic or local infection);
4 Insufficient comprehension to use the PCA device,
5 History of drug abuse,
6 Severe cardiovascular disease
7 Patient with neurological disorder
8 Recent use of psychoactive or analgesic medication.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the effect of intrathecal morphine versus ESPB in terms of duration and quality of analgesia and post operative analgesic consumption

 
postoperative hours

 
 
Secondary Outcome  
Outcome  TimePoints 
Effect on catheter related bladder discomfort
To observe any procedure and drug related complications 
postoperative hours 
 
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 4 
Date of First Enrollment (India)   19/01/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Post operative pain is a major concern after any surgery. Inadequate control of pain after major surgeries continues to be a cause of worry since it may be associated with a delay in recovery leading to an increase in incidence of chronic post surgical pain. At present, there are numerous methods exist for post operative pain management after major abdominal surgeries such as intrathecal or intravenous(I.V)opioids, epidural analgesia, and ultrasound guided peripheral nerve blocks,however options for post‑kidney transplantation analgesia are limited due to associated comorbidities in kidney transplant recipients. Ultrasound guided regional anaesthesia is an upcoming and rapidly progressive method of pain management. The ultrasound guided erector spinae plane block (ESPB) is a newer regional anaesthesia technique  currently being explored as a viable option for analgesia. ESPB is performed by injecting local anaesthetic in the plane between the erector spinae muscle and transverse process. Both intrathecal morphine and ESPB has been investigated for use in post-operative analgesia for various surgeries like total abdominal hysterectomy, laparoscopic cholecystectomy, percutaneous nephrolithotomy, open nephrectomy, but there are very limited studies in regarding there use in kidney transplant recepients. With the hypothesis that both intra-thecal morphine and ultrasound guided ESPB has effect on post operative pain management So, this study is being planned to compare and evaluate  both modalities and observe the duration, quality of analgesia and post operative analgesic consumption in the patients undergoing kidney transplantation.

 

 
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