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

Phase 2/3

Not yet recruiting

Conditions: End stage renal disease, (2) ICD-10 Condition: O||Medical and Surgical,

Registration Number: CTRI/2025/06/089164

Lead Sponsor: Konjengbam Ghanashyam

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 126

Inclusion Criteria

ASA 2/3 undergoing live related renal transplant.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
NRS (Numerical rating scale) score for pain	postop hours 1, 6, 12, 24, 36, 48
duration of hospital stay	end of surgery till hospital discharge
incidence & duration of post operative mechanical ventilation	28 days
Requirement of rescue analgesia	24 hours postoperatively
respiratory depression	postop hours 1, 6, 12, 24, 36, 48
To demonstrate that both the treatment groups perform better than the control group (no intrathecal opioids)	24 hour post operatively
Pruritis	postop hours 1, 6, 12, 24, 36, 48
Postoperative nausea, vomiting	postop hours 1, 6, 12, 24, 36, 48
time to first mobilisation	48 hours postoperative
incidence of delayed graft function	7 postoperative days

Trial Locations

Locations (1): Postgraduate Institute of Medical Education and Research, Chandigarh
🇮🇳
Chandigarh, CHANDIGARH, India
Postgraduate Institute of Medical Education and Research, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Prof Sameer Sethi
Principal investigator
9317851002
drsameersethi29@gmail.com