| CTRI Number |
CTRI/2025/06/089164 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Compare Low Dose Intrathecal Morphine With Fentanyl vs Intrathecal Morphine in Renal Transplant Patients |
|
Scientific Title of Study
|
Comparison of lower dose of intrathecal morphine with fentanyl versus intrathecal morphine on post operative outcomes in patients undergoing renal transplant: a randomized 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 |
Konjengbam Ghanashyam |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Eduaction and Research |
| Address |
Department of Anesthesia and Intensive care, 4th floor, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7005969178 |
| Fax |
|
| Email |
Ghana8494kay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sameer Sethi |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Eduaction and Research |
| Address |
Department of Anesthesia and Intensive care, 4th floor, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9317851002 |
| Fax |
|
| Email |
drsameersethi29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Sameer Sethi |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Eduaction and Research |
| Address |
Department of Anesthesia and Intensive care, 4th floor, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9317851002 |
| Fax |
|
| Email |
drsameersethi29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Konjengbam Ghanashyam |
| Address |
Dept of Anesthesia and Intensive care , PGIMER, Chandigarh,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 |
| Prof Sameer Sethi |
Postgraduate Institute of Medical Education and Research, Chandigarh |
Renal transplant OT, Nehru Hospital, 4th floor, PGIMER, Chandigarh, 160012
Chandigarh
CHANDIGARH |
9317851002
drsameersethi29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intrathecal morphine 200 |
morphine 200 mcg will be given intrathecally; ; Time point - preoperative (single injection/dose); iv fentanyl will be given post surgery as rescue analgesia (24 hours post surgery) |
| Intervention |
intrathecal morphine 100 , fentanyl 15 |
morphine 100 mcg plus fentanyl 15 mcg will be given intrathecally; Time point - preoperative (single injection/dose); iv fentanyl will be given post surgery as rescue analgesia (24 hours post surgery) |
| Comparator Agent |
no intervention |
no drugs will be given intrathecally at the start of surgery. Instead , iv fentanyl will be given post surgery as rescue analgesia (24 hours post surgery) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 2/3 undergoing live related renal transplant |
|
| ExclusionCriteria |
| Details |
Patient refusal
History of allergy to study drug
Coagulopathy
Severe cardiac disease
Deceased donor renal transplant
Patients who are intubated for at least a minimum duration of 24 hours.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate that intrathecal (100 microgram) morphine + (15 microgram) fentanyl provides a postoperative quality of recovery (QoR15) that is non-inferior to 200 microgram intrathecal morphine on postoperative day 1 |
postoperative day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To demonstrate that both the treatment groups perform better than the control group (no intrathecal opioids) |
24 hour post operatively |
| NRS (Numerical rating scale) score for pain |
postop hours 1, 6, 12, 24, 36, 48 |
| Requirement of rescue analgesia |
24 hours postoperatively |
| Postoperative nausea, vomiting |
postop hours 1, 6, 12, 24, 36, 48 |
| Pruritis |
postop hours 1, 6, 12, 24, 36, 48 |
| respiratory depression |
postop hours 1, 6, 12, 24, 36, 48 |
| time to first mobilisation |
48 hours postoperative |
| duration of hospital stay |
end of surgery till hospital discharge |
| incidence & duration of post operative mechanical ventilation |
28 days |
| incidence of delayed graft function |
7 postoperative days |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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 - NO
|
|
Brief Summary
|
Post operative pain remains a challenge for patients especially after a major surgery. Renal transplant surgery presents a major post operative pain owing to its large incision site and its association with its somatic and visceral pain as well as the complexity of the patient’s comorbidities. Transplant recipients have often underlying conditions such as hypertension and cardiovascular disease which can complicate pain management strategies. Intrathecal morphine provides excellent and long lasting analgesia after different types of surgical procedure due to its hydrophilic nature, maintaining CSF concentration for longer duration (24-48 hours) with slower onset (45-60 minutes). Intrathecal fentanyl has been relatively used in caesarian sections, lower extremity surgery , urology and ambulatory day surgeries and found it to be effective in improving postoperative pain due its lipophilic nature having a high affinity to receptors and produces a rapid onset of action (10-20 minutes). But, it can also rapidly diffuse rapidly into non neuronal tissues such as myelin and epidural fat causing CSF concentration to fall rapidly and shortening its duration of action (4-6 hours). We hypothesized that with intraoperative administration of lower dose of morphine with fentanyl, the dose dependant side effects of morphine might be diminished, improve immediate postoperative pain control resulting in reduced post operative opioid intake and improved outcomes for patients undergoing renal transplant surgery. |