The Intrathecal Morphine for Nephrectomy

The Efficacy of Intrathecal Morphine in Patients Undergoing Open Nephrectomy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01997788

Acronym

EMPON

Enrollment

Registered

2013-11-28

Start date

2013-08-31

Completion date

2013-10-31

Last updated

2015-07-03

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

Conditions

Renal Cell Carcinoma

Keywords

Injection, Spinal, Morphine, Analgesia, Patient-Controlled, Pain, Postoperative, Combined Modality Therapy, Nephrectomy

Brief summary

To evaluate the efficacy and the safety of the intrathecal morphine injection in the open nephrectomy.

Detailed description

The open nephrectomy is the treatment of choice for live donor kidney transplantation and renal cell carcinoma. The incision for the nephrectomy causes severe postoperative pain. A single dose of intrathecal morphine(ITM) has been used for the postoperative pain of prostatectomy, transurethral resection of the prostate and hepatectomy. The effect of ITM for open nephrectomy has not been studied. Therefore, this prospective, randomized study will evaluate the efficacy and safety of a single 50 mcg dose of ITM added to intravenous patient controlled analgesia(IV-PCA), comparing to IV-PCA alone.

Interventions

DRUGThe intrathecal morphine injection

A single injection of morphine intrathecally

DRUGThe intravenous patient-controlled analgesia

The intravenous injection of morphine using the patient-controlled analgesia machine

DRUGDemerol on demand

Demerol 25 mg intravenously when pain scores more than 5.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients scheduled for the open nephrectomy

Exclusion criteria

* Patients with renal insufficiency * Patients with coagulopathy * History of any neurologic disorder * History of recent infection in 2 weeks * History of drug abuse * Patients who cannot understand the usage of th intravenous patient-controlled analgesia * Patients using opioids due to the chronic pain

Design outcomes

Primary

Measure	Time frame	Description
The evaluation of pain at 24 hours after surgery	at postoperatively 24 hours	The doctor blinded to the investigation will visit patients. The pain will be assessed at rest and at coughing using visual analogue scale.

Secondary

Measure	Time frame	Description
The consumption of analgesics	at postoperatively 24 hours	The total amount of opioids (IV morphine) used for 24 hours after surgery will be recorded and compared.
The consumption of intraoperative opioids	From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours	The total amount of intraoperative opioids (IV remifentanil) will be recorded and compared.
The side effects of opioids after surgery	During 72 hours after the end of surgery	Any side effects of opioids including nausea, vomiting, dizziness, sedation, headache, pruritus and respiratory depression will be recorded.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026