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

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ClinicalTrials.gov Identifier: NCT02445599
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Tamas Vegh, MD, University of Debrecen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Inadequate or Impaired Respiratory Function Drug: Diclofenac Drug: Midazolam Drug: Atropine Drug: bucain + fentanyl Drug: Nalbuphine Drug: Metamizole-sodium Drug: Tramadol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Diclofenac Stada 100 mg retard

Drug: Midazolam
5 mg Dormicum intramuscularly, administered 1 hour before surgery
Other Name: Dormicum 5mg/ml

Drug: Atropine
0.5 mg Atropine intramuscularly, administered 1 hour before surgery
Other Name: 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 Name: Nubain 20mg/2ml

Drug: Diclofenac
2nd choice for rescue analgetic 250ml intravenously
Other Name: Neodolpasse 75 mg/ 250ml

Drug: Metamizole-sodium
Additional rescue analgetic 2g intravenously
Other Name: Algopyrin 2g/2ml

Drug: Tramadol
Additional rescue analgetic 100mg intravenously
Other Name: 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: Midazolam
5 mg Dormicum intramuscularly, administered 1 hour before surgery
Other Name: Dormicum 5mg/ml

Drug: Atropine
0.5 mg Atropine intramuscularly, administered 1 hour before surgery
Other Name: 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 Name: Nubain 20mg/2ml

Drug: Diclofenac
2nd choice for rescue analgetic 250ml intravenously
Other Name: Neodolpasse 75 mg/ 250ml

Drug: Metamizole-sodium
Additional rescue analgetic 2g intravenously
Other Name: Algopyrin 2g/2ml

Drug: Tramadol
Additional rescue analgetic 100mg intravenously
Other Name: Contramal 100mg/2ml




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445599


Locations
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Hungary
UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care
Debrecen, Hajdú-Bihar, Hungary, 4032
Sponsors and Collaborators
University of Debrecen
Investigators
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Principal Investigator: Béla Fülesdi, MD,PhD,DSci UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032
Publications of Results:
Other Publications:
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Responsible Party: Tamas Vegh, MD, MD, PhD assistant professor anesthesiologist and intensive care specialist, University of Debrecen
ClinicalTrials.gov Identifier: NCT02445599    
Other Study ID Numbers: DEOEC RKEB/IKEB 4044-2013
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Keywords provided by Tamas Vegh, MD, University of Debrecen:
thoracotomy
pain management
analgesia
postoperative care
premedication
preventive
Additional relevant MeSH terms:
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Shoulder Pain
Respiratory Insufficiency
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Respiration Disorders
Respiratory Tract Diseases
Dipyrone
Diclofenac
Atropine
Fentanyl
Midazolam
Tramadol
Nalbuphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents