Thoracic Paravertebral Blocks in Open 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

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-09

Study Completion Date

2023-02-01

Brief Summary

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60 patients ASA I-III, undergoing open nephrectomy will be randomly assigned into one of two groups, namely group A (n=30), where a thoracic paravertebral block will be performed preoperatively and a paravertebral catheter for continuous and patient controlled bolus local anesthetic (ropivacaine) doses will be inserted and group B (n=30) where morphine IV will be administered at the beginning and the end of operation and postoperatively through patient controlled IV doses. NRS scores in static and dynamic conditions, complications, patient satisfaction, oxidative stress (through lactic acid, superoxide dismutase, malondialdehyde) and NGAL pre- and postoperatively, will be recorded.

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Detailed Description

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Conditions

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Nephrectomy Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A

Thoracic paravertebral block using ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Paravertebral block using ropivacaine preoperatively and postoperatively

Group B

Morphine IV

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Morphine intraoperatively and postoperatively

Interventions

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Ropivacaine

Paravertebral block using ropivacaine preoperatively and postoperatively

Intervention Type DRUG

Morphine

Morphine intraoperatively and postoperatively

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Physical status according to American Society of Anesthesiologists (ASA) I-III
* Patients scheduled for open nephrectomy

Exclusion Criteria

* Previous operation on same kidney
* Contraindication of paravertebral block or any of the agents used in the protocol
* BMI above 32
* Any concurrent malignancy not cured
* Serious psychiatric, mental and cognitive disorders
* Block failure
* Chronic pain
* Severe kidney disfunction

Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No