The Intrathecal Morphine for Nephrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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The ITM group

The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.

Group Type EXPERIMENTAL

The intrathecal morphine injection

Intervention Type DRUG

A single injection of morphine intrathecally

The intravenous patient-controlled analgesia

Intervention Type DRUG

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

Demerol on demand

Intervention Type DRUG

Demerol 25 mg intravenously when pain scores more than 5.

The IV-PCA group

The postoperative pain management includes only the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.

Group Type PLACEBO_COMPARATOR

The intravenous patient-controlled analgesia

Intervention Type DRUG

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

Demerol on demand

Intervention Type DRUG

Demerol 25 mg intravenously when pain scores more than 5.

Interventions

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The intrathecal morphine injection

A single injection of morphine intrathecally

Intervention Type DRUG

The intravenous patient-controlled analgesia

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

Intervention Type DRUG

Demerol on demand

Demerol 25 mg intravenously when pain scores more than 5.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No