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