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NCT Number: NCT02445599

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

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.

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Key information

Conditions

Pain Agnosia Inadequate or Impaired Respiratory Function Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care

Debrecen, Hajdú-Bihar, 4032, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac

Drug

Orally 100 mg Diclofenac, administered 1 hour before surgery

Other names: Diclofenac Stada 100 mg retard

midazolam

Drug

5 mg Dormicum intramuscularly, administered 1 hour before surgery

Other names: Dormicum 5mg/ml

Atropine

Drug

0.5 mg Atropine intramuscularly, administered 1 hour before surgery

Other names: Atropine 1 mg/ml

bucain + fentanyl

Drug

Via the thocacic epidural cannula 1mg/ml bucain + 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed is administered.

Nalbuphine

Drug

1st choice for rescue analgetic 10-20 mg intravenously

Other names: Nubain 20mg/2ml

Metamizole-sodium

Drug

Additional rescue analgetic 2g intravenously

Other names: Algopyrin 2g/2ml

Tramadol

Drug

Additional rescue analgetic 100mg intravenously

Other names: Contramal 100mg/2ml

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Debrecen

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 15, 2015
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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