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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445599
• Other study ID #: DEOEC RKEB/IKEB 4044-2013
• Status: Completed
• Phase: Phase 4
• First received: December 11, 2014
• Last updated: March 8, 2017
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: March 2017
• Source: University of Debrecen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Inadequate or Impaired Respiratory Function
• Pain
• Respiratory Insufficiency
• Shoulder Pain

Intervention

Drug:
• Diclofenac
Orally 100 mg Diclofenac, administered 1 hour before surgery
• Midazolam
5 mg Dormicum intramuscularly, administered 1 hour before surgery
• Atropine
0.5 mg Atropine intramuscularly, administered 1 hour before surgery
• bucain + fentanyl
Via the thocacic epidural cannula 1mg/ml bucain + 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed is administered.
• Nalbuphine
1st choice for rescue analgetic 10-20 mg intravenously
• Diclofenac
2nd choice for rescue analgetic 250ml intravenously
• Metamizole-sodium
Additional rescue analgetic 2g intravenously
• Tramadol
Additional rescue analgetic 100mg intravenously

Locations

Country	Name	City	State
Hungary	UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care	Debrecen	Hajdú-Bihar

Sponsors (1)

Lead Sponsor	Collaborator
University of Debrecen

Country where clinical trial is conducted

Hungary, 

References & Publications (7)

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

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. — View Citation

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

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

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

Nesek-Adam V, Grizelj-Stojcic E, Mršic V, Rašic 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 Percuta — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analgetic need during the first five postoperative days.	The total amount of administered analgetics were recorded during the first five postoperative days and then converted into intramuscular morphine equivalents.	Participants were followed for 5 days postoperatively
Other	Postoperative complications during the first five postoperative days	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.	Participants were followed for 5 days postoperatively
Other	Intraoperative fentanyl use	Intraoperative fentanyl use was registered as micrograms per kilogram body weight and micrograms per hour as well.	Participants were followed during the operation on day 1
Other	Epidurally administered local anethetics	The total amount of epidurally administered local anesthetic were recorded during the first five postoperative days.	Participants were followed for 5 days postoperatively
Other	Comparing the pre- and postoperative lung function test values	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.	Participants were followed for 5 days postoperatively
Primary	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.	5 days
Secondary	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.	5 days