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CTRI Number  CTRI/2024/09/073572 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 06/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison of different doses of morphine given in spinal space on pain relief after surgery in in renal transplant patients 
Scientific Title of Study   Comparison Of Two Different Doses Of Intrathecal Morphine On Postoperative Analgesia In Renal Transplant Recipients. A Non-Inferiority Randomised 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  Arika Yadav 
Designation  Junior Resident 
Affiliation  Postgraduate Institute of Medical Education and research, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, PGIMER, Sector 12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009545  
Fax    
Email  arikayadav007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kamal Kajal 
Designation  Additional professor 
Affiliation  Postgraduate Institute of Medical Education and research, Chandigarh 
Address  Department of anaesthesia and intensive care, PGIMER, Sector 12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  09560412726  
Fax    
Email  kamal.kajal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kamal Kajal 
Designation  Additional professor 
Affiliation  Postgraduate Institute of medical education and research, Chandigarh 
Address  Department of anaesthesia and intensive care, PGIMER, Sector 12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  09560412726  
Fax    
Email  kamal.kajal@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of medical education and research, Sector 12, Chandigarh, India, 160012  
 
Primary Sponsor  
Name  Postgraduate Institute of medical education and research  
Address  Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India, 160012  
Type of Sponsor  Research institution and hospital 
 
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 Kamal Kajal  Renal transplant Operation theatre  Department of anaesthesia and intensive care, PGIMER, Sector 12 Chandigarh
Chandigarh
CHANDIGARH 
09560412726

kamal.kajal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Thesis committee clinical  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  Intrathecal 200 Group received 200 micrograms of intrathecal morphine  Route of administration: intrathecal space Dose: 0.2 mg of preservative-free morphine. Frequency: single dose at induction of anaesthesia  
Comparator Agent  Intrathecal morphine 400 Group received 400 micrograms of intrathecal morphine  Route of administration: intrathecal space Dose: 0.4 mg of preservative-free morphine. Frequency: single dose at induction of anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All living donor kidney transplant patients with age more than 18 years will be included in the study. 
 
ExclusionCriteria 
Details  Refusal to give informed consent, Contraindications to regional block, Patients undergoing additional transplant, Deceased donor kidney transplant patients,Recent use of analgesic medication 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be to assess pain score using Visual Analogue scale (VAS) at rest postoperatively  VAS at (Arrival in recovery), 2h, 6h, 24 h, 48 hr, 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Cumulative opioid consumption  24h, 48h and 72 hours 
Quality of recovery score (QoRS) 15 score  24h, 48h and 72 hours 
Occurrence of pruritis and postoperative nausea and vomiting ( PONV)  ONV/Prurits at (Arrival in recovery), 2h, 6h, 24 h, 48 hr, 72 hours 
Incidence respiratory depression  RR at (Arrival in recovery), 2h, 6h, 24 h, 48 hr, 72 hours 
Need for rescue analgesia for severe pain  Need for rescue analgesia at (Arrival in recovery), 2h, 6h, 24 h, 48 hr, 72 hours 
Length of stay in the hospital  At discharge 
Time to return of bowel movements  Time in days to return of bowel movements 
RASS sedation score  RASS at (Arrival in recovery), 2h, 6h, 24 h, 48 hr, 72 hours 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   18/09/2024 
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="6"
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  

Adequate pain control is an essential aspect of perioperative care. Poor pain control can lead to profound agitation, sympathetic overactivity like tachycardia and hypertension, and a higher risk of cardiovascular and pulmonary complications. However, pain management can be challenging secondary to the higher burden of comorbid disease and altered pharmacokinetics due to renal failure in this patient population. The optimal analgesic strategy for kidney transplant patients is not clearly defined. Pain control for kidney transplantation is achieved by using intravenous (IV) opioid medications, with a preference for opioids with minimal renal excretion for either the original compound or its metabolites. Additional approaches to pain management include local anaesthetic wound infiltration, transversus abdominis plane (TAP), and epidural analgesia. The use of intrathecal opioids is also a well-established pain management option for managing postoperative pain in major abdominal surgeries.It has also shown effectiveness in living donors undergoing liver transplantation. The significant benefits of intrathecal hydrophilic opioids over i.v. administration are believed to be due to their higher potency and prolonged action due to the low CSF distribution volume and remarkably slow diffusion. Single-shot intrathecal morphine has also been accepted in Enhanced Recovery After Surgery (ERAS) protocols due to its lower rate of technical failure. In addition, its use also ameliorates the need for patient-controlled analgesia (PCA) pump care and catheter care. These benefits make it an effective pain control strategy in ERAS settings. However, the adverse effects reported are pruritus, nausea, and late respiratory depression. Meylan and colleagues21 performed a meta-analysis with predominant studies related to cardiac surgery, which found higher rates of pruritus and respiratory depression. However, a wide range of dosages were used by the included studies. Gehling and Tryba, in their study, found a dose dependent effect for respiratory depression with a cut-off of 300 micrograms of intrathecal morphine. Koning et al. in their meta-analysis on the use of intrathecal opioids in major abdominal surgeries, recommended the use of dosages less than 500 micrograms intrathecally. However, low-dose intrathecal morphine is suggested as a reliable and cost effective regional anaesthesia option. We aimed to define better define the duration and effectiveness of ITM for postoperative pain control in the setting of the established ERAS protocol for kidney transplant surgeries. We hypothesized that in the setting of the ERAS pathway, including multimodal analgesia, 200 micrograms of intrathecal morphine will provide a non-inferior duration of pain control when compared to 400 micrograms of ITM. 


 
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