NCT03105765

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

3.6 years

First QC Date

August 12, 2016

Last Update Submit

April 3, 2017

Conditions

Acute PainChronic PainNeuropathic Pain

Keywords

Neuropathic PainChronic PainPosterolateral thoracotomy

Outcome Measures

Primary Outcomes (3)

  • Change in perioperative opioid consumption

    The patients consumption of opioids is recorded once a day for a period of 7 days after operation.

    seven 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.

    7 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

    7 days after operation

Secondary Outcomes (4)

  • Change in chronic Pain

    one and three month after operation

  • Chronic Neuropathic pain

    one month after operation

  • Chronic Neuropathic Pain

    three month after operation

  • recovery time

    eye opening after stopping anesthesia in minutes

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

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.

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

PlaceboDRUG

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

Placebo
KetamineDRUG

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.

Ketamine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Horst Schmidt Klinik

Wiesbaden, Hesse, 65199, Germany

Location

Related Publications (1)

  • Ghezel-Ahmadi V, Beck G, Bolukbas S, Ghezel-Ahmadi D. Perioperative ketamine to reduce and prevent acute and chronic post-thoracotomy pain: a randomized, double-blind, placebo-controlled clinical trial. J Thorac Dis. 2024 Dec 31;16(12):8461-8471. doi: 10.21037/jtd-24-648. Epub 2024 Dec 28.

    PMID: 39831260DERIVED

MeSH Terms

Conditions

Acute PainChronic PainNeuralgia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2016

First Posted

April 10, 2017

Study Start

January 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2016

Last Updated

April 10, 2017

Record last verified: 2017-04

Locations

DE(1)