Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain

March 8, 2017 updated by: Tamas Vegh, MD, University of Debrecen

Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain, as Well as the Changes of the Postoperative Breathing Function Values, a Randomized, Controlled, Prospective Trial

The purpose of the study is to examine if the hyposthesis of the preventive analgestic characteristic of diclofenac given preoperatively has any effect on postoperative thoracic wall and shoulder pain sensation. We also want to examine the rescue analgetic consumption and the postoperative lung function test values.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction Thoracotomies are thought to be one of the most difficult surgical incisions to deal with post-operatively, because they are extremely painful and the pain can prevent the patient from breathing effectively. Currently in our institute the surgical and post-operative anelgesia are managed by the combination of local anesthetics and opioid pain killers through an epidural cannula. In addition the investigators give diclofenac intravenously (from the 2nd day after the operation per os) as well as nalbuphin is given intravenously to the patients if it is necesserary.

By definition pre-emptive analgesia means that the treatment of pain is initiated before the surgical procedure by analgetics or nerve blockade techniques. The purpose of this method is to inhibit the production of inflammatory mediators and the prevention of the pain stimulus entering the central nervous system. As a result of the pre-emptive antinociceptive treatment, the quantity of post-operative medications can be decreased, the analgesia has less complications and the patients are more satisfied.

In the study the researchers would like to examine the pre-emptive analgetic effect of diclofenac.

Patients and methods:

Patients undergoing thoracotomy are divided into two groups.:

  • Study Group: 100mg diclofenac per os (n=50)
  • Control Group: patients do not get diclofenac premedication (n=50) The investigators examine every patient for five days: they record the patients' pain with the help of the Visual Analogue Scale (VAS). We measure the analgetic consumption in intramuscular morphin equivalent dose and the local anesthetic consumption via epidural cannula seperately. The lung function testing was carried out two times postoperatively with the help of the MIR Spirolab II mobil spirometer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 100 thoracotomy patients who agreed to take part in our study and signed a consent
  • age 18-80 years
  • ASA I-III
  • men/women equally
  • thoracotomies are managed with using intratracheal double lumen tube
  • insertion of thoracic epidural cannula and during the operation administration of 1mg/ml bucain, 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed

Exclusion Criteria:

  • acute operation
  • diclofenac allergy in the anamnesis
  • the lack of thoracic epidural cannula

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Diclofenac group

Diclofenac 100 mg tablet were administered orally and Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication, 60 minutes before surgical interventions.

Every patient recieved additional thoracic epidural analgesia during and after the surgery.

As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
Drug: Diclofenac
Orally 100 mg Diclofenac, administered 1 hour before surgery
Other Names:
  • Diclofenac Stada 100 mg retard
Drug: Midazolam
5 mg Dormicum intramuscularly, administered 1 hour before surgery
Other Names:
  • Dormicum 5mg/ml
Drug: Atropine
0.5 mg Atropine intramuscularly, administered 1 hour before surgery
Other Names:
  • Atropine 1 mg/ml
Drug: bucain + fentanyl
Via the thocacic epidural cannula 1mg/ml bucain + 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed is administered.
Drug: Nalbuphine
1st choice for rescue analgetic 10-20 mg intravenously
Other Names:
  • Nubain 20mg/2ml
Drug: Diclofenac
2nd choice for rescue analgetic 250ml intravenously
Other Names:
  • Neodolpasse 75 mg/ 250ml
Drug: Metamizole-sodium
Additional rescue analgetic 2g intravenously
Other Names:
  • Algopyrin 2g/2ml
Drug: Tramadol
Additional rescue analgetic 100mg intravenously
Other Names:
  • Contramal 100mg/2ml
Experimental: Control group

Midazolam 5 mg + Atropine 0.5 mg were administered intramuscularly as premedication 60 minutes before surgical interventions.

Every patient recieved additional thoracic epidural analgesia during and after the surgery.

As rescue medication patients get nalbuphine 10-20mg, diclofenac 75 mg + orphenadrine 30 mg (NEODOLPASSE infusion), metamizole-sodium 2g, tramadol 50-100mg as needed postoperatively.
Drug: Diclofenac
Orally 100 mg Diclofenac, administered 1 hour before surgery
Other Names:
  • Diclofenac Stada 100 mg retard
Drug: Midazolam
5 mg Dormicum intramuscularly, administered 1 hour before surgery
Other Names:
  • Dormicum 5mg/ml
Drug: Atropine
0.5 mg Atropine intramuscularly, administered 1 hour before surgery
Other Names:
  • Atropine 1 mg/ml
Drug: bucain + fentanyl
Via the thocacic epidural cannula 1mg/ml bucain + 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed is administered.
Drug: Nalbuphine
1st choice for rescue analgetic 10-20 mg intravenously
Other Names:
  • Nubain 20mg/2ml
Drug: Diclofenac
2nd choice for rescue analgetic 250ml intravenously
Other Names:
  • Neodolpasse 75 mg/ 250ml
Drug: Metamizole-sodium
Additional rescue analgetic 2g intravenously
Other Names:
  • Algopyrin 2g/2ml
Drug: Tramadol
Additional rescue analgetic 100mg intravenously
Other Names:
  • Contramal 100mg/2ml

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
10% reduction of the thoracotomy pain recorded by VAS score.
Time Frame: 5 days
Our main goal is to achieve 10% reduction of the thoracotomy pain recorded by VAS score, compared to the non-diclofenac control group.
5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
10% reduction of the shoulder pain recorded by VAS score.
Time Frame: 5 days
Our second goal is to achieve 10%reduction of the shoulder pain recorded by VAS score, compared to the non-diclofenac control group.
5 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analgetic need during the first five postoperative days.
Time Frame: Participants were followed for 5 days postoperatively
The total amount of administered analgetics were recorded during the first five postoperative days and then converted into intramuscular morphine equivalents.
Participants were followed for 5 days postoperatively
Postoperative complications during the first five postoperative days
Time Frame: Participants were followed for 5 days postoperatively

Intraoperative fentanyl use was registered as micrograms per kilogram body weight and micrograms per hour as well.

Postoperative complications such as bleeding at the surgical site, gastrointestinal problems or kidney dysfunctions were also registered.
Participants were followed for 5 days postoperatively
Intraoperative fentanyl use
Time Frame: Participants were followed during the operation on day 1
Intraoperative fentanyl use was registered as micrograms per kilogram body weight and micrograms per hour as well.
Participants were followed during the operation on day 1
Epidurally administered local anethetics
Time Frame: Participants were followed for 5 days postoperatively
The total amount of epidurally administered local anesthetic were recorded during the first five postoperative days.
Participants were followed for 5 days postoperatively
Comparing the pre- and postoperative lung function test values
Time Frame: Participants were followed for 5 days postoperatively
Comparing the pre- and postoperative lung function test values with and after the removal of chest drains. The measurement were executed by the MIR Spirolab II bedside spirometer.
Participants were followed for 5 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Debrecen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bela Fulesdi, MD,PhD,DSci, UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DEOEC RKEB/IKEB 4044-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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