To Compare Low Dose Intrathecal Morphine With Fentanyl vs Intrathecal Morphine in Renal Transplant Patients

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 - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089164

Enrollment

126

Registered

2025-06-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N186- End stage renal disease Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: 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) Intervention2: intrathecal morphine 200: morphine 200 mcg will be given intrathecally

iv fentanyl will be given post surgery as rescue analgesia (24 hours post surgery) Control Intervention1: no intervention: no drugs will be given intrathecally at the start of surgery. Instead , iv fe

Eligibility

Inclusion criteria

Inclusion criteria: ASA 2/3 undergoing live related renal transplant

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 1Timepoint: postoperative day 1	—

Secondary

Measure	Time frame
To demonstrate that both the treatment groups perform better than the control group (no intrathecal opioids)Timepoint: 24 hour post operatively;NRS (Numerical rating scale) score for painTimepoint: postop hours 1, 6, 12, 24, 36, 48;Requirement of rescue analgesiaTimepoint: 24 hours postoperatively;Postoperative nausea, vomitingTimepoint: postop hours 1, 6, 12, 24, 36, 48;PruritisTimepoint: postop hours 1, 6, 12, 24, 36, 48;respiratory depressionTimepoint: postop hours 1, 6, 12, 24, 36, 48;time to first mobilisationTimepoint: 48 hours postoperative;duration of hospital stayTimepoint: end of surgery till hospital discharge;incidence & duration of post operative mechanical ventilationTimepoint: 28 days;incidence of delayed graft functionTimepoint: 7 postoperative days	—

Measure

Time frame

To demonstrate that both the treatment groups perform better than the control group (no intrathecal opioids)Timepoint: 24 hour post operatively;NRS (Numerical rating scale) score for painTimepoint: postop hours 1, 6, 12, 24, 36, 48;Requirement of rescue analgesiaTimepoint: 24 hours postoperatively;Postoperative nausea, vomitingTimepoint: postop hours 1, 6, 12, 24, 36, 48;PruritisTimepoint: postop hours 1, 6, 12, 24, 36, 48;respiratory depressionTimepoint: postop hours 1, 6, 12, 24, 36, 48;time to first mobilisationTimepoint: 48 hours postoperative;duration of hospital stayTimepoint: end of surgery till hospital discharge;incidence & duration of post operative mechanical ventilationTimepoint: 28 days;incidence of delayed graft functionTimepoint: 7 postoperative days

—

Countries

India

Contacts

Public ContactProf Sameer Sethi

Post Graduate Institute of Medical Eduaction and Research

drsameersethi29@gmail.com9317851002

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026