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

Information source: University of Debrecen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain; Inadequate or Impaired Respiratory Function

Intervention: Diclofenac (Drug); Midazolam (Drug); Atropine (Drug); bucain + fentanyl (Drug); Nalbuphine (Drug); Diclofenac (Drug); Metamizole-sodium (Drug); Tramadol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Debrecen

Official(s) and/or principal investigator(s):
Béla Fülesdi, MD,PhD,DSci, Principal Investigator, Affiliation: UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032

Overall contact:
Balázs Pálóczi, MD, Phone: +36309396048, Email: paloczib82@gmail.com


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 10% reduction of the thoracotomy pain recorded by VAS score.

Secondary outcome: 10% reduction of the shoulder pain recorded by VAS score.

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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


Inclusion Criteria:

- 100 thoracotomy patients who agreed to take part in our study and signed a consent

- age 18-80 years


- 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

Locations and Contacts

Balázs Pálóczi, MD, Phone: +36309396048, Email: paloczib82@gmail.com

UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care, Debrecen, Hajdú-Bihar 4032, Hungary; Recruiting
Balázs Pálóczi, MD, Phone: +3630/9396048, Email: paloczib82@gmail.com
Erzsébet Igbonu-Nagy, Email: nagyboske@yahoo.com
Additional Information

Related publications:

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

Gottschalk A, Cohen SP, Yang S, Ochroch EA. Preventing and treating pain after thoracic surgery. Anesthesiology. 2006 Mar;104(3):594-600. Review.

Koehler RP, Keenan RJ. Management of postthoracotomy pain: acute and chronic. Thorac Surg Clin. 2006 Aug;16(3):287-97. Review.

Ochroch EA, Gottschalk A. Impact of acute pain and its management for thoracic surgical patients. Thorac Surg Clin. 2005 Feb;15(1):105-21. Review.

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

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.

Starting date: April 2014
Last updated: May 14, 2015

Page last updated: August 23, 2015

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