| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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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
|
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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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