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

Primary Purpose

Acute Pain, Chronic Pain, Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Placebo
Ketamine
Sponsored by
Dr. Horst Schmidt Klinik GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pain focused on measuring Neuropathic Pain, Chronic Pain, Posterolateral thoracotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Horst Schmidt Klinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ketamine

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in perioperative opioid consumption
The patients consumption of opioids is recorded once a day for a period of 7 days after operation.
Change in acute pain
The incidence and severity of pain will be measured using a numeric analog scale (NAS) once a day for a period of seven days after Operation.
acute neuropathic pain
The incidence of neuropathic pain will be measured using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) three and seven days after operation

Secondary Outcome Measures

Change in chronic Pain
The incidence and severity of pain will be measured using a numeric analog scale (NAS). Pain scale is requested by phone one and three month after Operation.
Chronic Neuropathic pain
The incidence of neuropathic pain will be measured by using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) one month after operation
Chronic Neuropathic Pain
The incidence of neuropathic pain will be measured by using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) three month after operation
recovery time
Time between stopping intravenous anaesthesia and first eye opening of the Patient in minutes

Full Information

First Posted
August 12, 2016
Last Updated
April 3, 2017
Sponsor
Dr. Horst Schmidt Klinik GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03105765
Brief Title
Acute and Chronic Pain, Especially Neuropathic Pain, After Thoracotomy and Continuous Application of Ketamine.
Official Title
Effects of Prophylactic Administration of Ketamine on Acute and Chronic Pain After Thoracotomy for Lung Cancer, a Double Blind Randomised Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Horst Schmidt Klinik GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Chronic Pain, Neuropathic Pain
Keywords
Neuropathic Pain, Chronic Pain, Posterolateral thoracotomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline applied by bolus before operation started, followed by a continuous application of normal saline for 24 hours.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in perioperative opioid consumption
Description
The patients consumption of opioids is recorded once a day for a period of 7 days after operation.
Time Frame
seven days after operation
Title
Change in acute pain
Description
The incidence and severity of pain will be measured using a numeric analog scale (NAS) once a day for a period of seven days after Operation.
Time Frame
7 days after Operation
Title
acute neuropathic pain
Description
The incidence of neuropathic pain will be measured using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) three and seven days after operation
Time Frame
7 days after operation
Secondary Outcome Measure Information:
Title
Change in chronic Pain
Description
The incidence and severity of pain will be measured using a numeric analog scale (NAS). Pain scale is requested by phone one and three month after Operation.
Time Frame
one and three month after operation
Title
Chronic Neuropathic pain
Description
The incidence of neuropathic pain will be measured by using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) one month after operation
Time Frame
one month after operation
Title
Chronic Neuropathic Pain
Description
The incidence of neuropathic pain will be measured by using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) three month after operation
Time Frame
three month after operation
Title
recovery time
Description
Time between stopping intravenous anaesthesia and first eye opening of the Patient in minutes
Time Frame
eye opening after stopping anesthesia in minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dr. Horst Schmidt Klinik
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65199
Country
Germany

12. IPD Sharing Statement

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

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