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PainPhase 4NCT02445599

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

A Phase 4 study testing Diclofenac, Midazolam and Atropine in people with Pain and Inadequate or Impaired Respiratory Function, run by University of Debrecen at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Diclofenac, Midazolam and Atropine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteHungary
Study dates
Apr 2014to Apr 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hungary1 site

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

    Debrecen, Hajdú-Bihar, 4032

Other trials in Hungary

About this study

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

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.

Read the 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.
Being tested
Diclofenac, Midazolam, Atropine, bucain + fentanyl, Nalbuphine
Keywords
thoracotomy, pain management, analgesia, postoperative care, premedication, preventive
Medical subject headings
Pain, Respiratory Insufficiency, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiclofenacDrug

    Also called Diclofenac Stada 100 mg retard

    Orally 100 mg Diclofenac, administered 1 hour before surgery

  • MidazolamDrug

    Also called Dormicum 5mg/ml

    5 mg Dormicum intramuscularly, administered 1 hour before surgery

  • AtropineDrug

    Also called Atropine 1 mg/ml

    0.5 mg Atropine intramuscularly, administered 1 hour before surgery

  • bucain + fentanylDrug

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

  • NalbuphineDrug

    Also called Nubain 20mg/2ml

    1st choice for rescue analgetic 10-20 mg intravenously

  • DiclofenacDrug

    Also called Neodolpasse 75 mg/ 250ml

    2nd choice for rescue analgetic 250ml intravenously

  • Metamizole-sodiumDrug

    Also called Algopyrin 2g/2ml

    Additional rescue analgetic 2g intravenously

  • TramadolDrug

    Also called Contramal 100mg/2ml

    Additional rescue analgetic 100mg intravenously

Study groups in NCT02445599
Study groupRoleWhat they receive
Diclofenac groupExperimentalDiclofenac 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.
Receives: Drug: Diclofenac; Drug: Midazolam; Drug: Atropine; Drug: bucain + fentanyl; Drug: Nalbuphine; Drug: Metamizole-sodium; Drug: Tramadol
Control groupExperimentalMidazolam 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.
Receives: Drug: Midazolam; Drug: Atropine; Drug: bucain + fentanyl; Drug: Nalbuphine; Drug: Diclofenac; Drug: Metamizole-sodium; Drug: Tramadol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 10% reduction of the thoracotomy pain recorded by VAS score.

    Our main goal is to achieve 10% reduction of the thoracotomy pain recorded by VAS score, compared to the non-diclofenac control group.

    Measured: 5 days

Secondary outcomes (1)

  1. 10% reduction of the shoulder pain recorded by VAS score.

    Our second goal is to achieve 10%reduction of the shoulder pain recorded by VAS score, compared to the non-diclofenac control group.

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02445599
Sponsor's protocol ID
DEOEC RKEB/IKEB 4044-2013
Status last verified
Mar 2017
First submitted
11 Dec 2014
Last updated
9 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.

    PubMed 18456219

  • Gottschalk A, Cohen SP, Yang S, Ochroch EA. Preventing and treating pain after thoracic surgery. Anesthesiology. 2006 Mar;104(3):594-600. doi: 10.1097/00000542-200603000-00027. No abstract available.

    PubMed 16508407

  • Koehler RP, Keenan RJ. Management of postthoracotomy pain: acute and chronic. Thorac Surg Clin. 2006 Aug;16(3):287-97. doi: 10.1016/j.thorsurg.2006.05.006.

    PubMed 17004557

  • Ochroch EA, Gottschalk A. Impact of acute pain and its management for thoracic surgical patients. Thorac Surg Clin. 2005 Feb;15(1):105-21. doi: 10.1016/j.thorsurg.2004.08.004.

    PubMed 15707349

  • McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. doi: 10.1017/s0033291700009934.

    PubMed 3078045

  • Gotoda Y, Kambara N, Sakai T, Kishi Y, Kodama K, Koyama T. The morbidity, time course and predictive factors for persistent post-thoracotomy pain. Eur J Pain. 2001;5(1):89-96. doi: 10.1053/eujp.2001.0225.

    PubMed 11394926

  • Nesek-Adam V, Grizelj-Stojcic E, Mrsic V, Rasic Z, Schwarz D. Preemptive use of diclofenac in combination with ketamine in patients undergoing laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study. Surg Laparosc Endosc Percutan Tech. 2012 Jun;22(3):232-8. doi: 10.1097/SLE.0b013e31824f8ae4.

    PubMed 22678319

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Diclofenac, Midazolam and Atropine in people with Pain and Inadequate or Impaired Respiratory Function, run by University of Debrecen at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

10% reduction of the thoracotomy pain recorded by VAS score. (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02445599, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.

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