Acute and Chronic Pain, Especially Neuropathic Pain, After Thoracotomy and Continuous Application of Ketamine.

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-08-31

Brief Summary

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Chronic Pain, especially neuropathic pain, are adverse events after posterolateral thoracotomy for lung resection. The continuous application of ketamine may have a prophylactic effect and helps to prevent chronic pain. The investigators record the incidence and severity of acute pain and neuropathic pain during a seven day period after thoracotomy as well as the incidence of chronic pain and neuropathic pain after one and three month period. Parallel Group design, comparing one Group with a continuous application (24 hours) of ketamine against a Placebo Group.

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Detailed Description

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Conditions

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Acute Pain Chronic Pain Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketamine

The patients in this Group underwent General anaesthesia with total intravenous anaesthesia containing remifentanil (0,02-0,04 mg/kg ideal Body weight), propofol (4-6 mg/kg ideal Body weight) and atracurium.

Ketamine 0,2 mg/kg ideal Body weight per hour for 24 hours.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Application of Ketamine 0,2mg/kg ideal Body weight by Bolus before the Operation started, followed by application of 0,2 mg/kg ideal Body weight for 24 hours.

Placebo

The patients in this Group underwent General anaesthesia with total intravenous anaesthesia containing remifentanil (0,02-0,04 mg/kg ideal Body weight), propofol (4-6 mg/kg ideal Body weight) and atracurium.

Placebo (normal Saline) for 24 hours.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal saline applied by bolus before operation started, followed by a continuous application of normal saline for 24 hours.

Interventions

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Placebo

Normal saline applied by bolus before operation started, followed by a continuous application of normal saline for 24 hours.

Intervention Type DRUG

Ketamine

Application of Ketamine 0,2mg/kg ideal Body weight by Bolus before the Operation started, followed by application of 0,2 mg/kg ideal Body weight for 24 hours.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* posterolateral thoracotomy for lung parenchyma resection
* informed consent
* ASA (American Society of Anesthesiologists) Status I-III

Exclusion Criteria

* history of chronic pain
* history of neuropathic pain
* pregnancy or breastfeeding
* participation in another trial
* hypersensitivity for ketamine
* medication with can influence neuropathic pain (gabapentin, clonazepam)
* history of neurological or behavioral illness
* history of alcohol abuse
* history of chemotherapy or radiation
* opioid medication

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No