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

NCT ID: NCT02445599

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-04-30

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.

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.

Conditions

Pain; Inadequate or Impaired Respiratory Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Diclofenac

Intervention Type: DRUG

Orally 100 mg Diclofenac, administered 1 hour before surgery

Midazolam

Intervention Type: DRUG

5 mg Dormicum intramuscularly, administered 1 hour before surgery

Atropine

Intervention Type: DRUG

0.5 mg Atropine intramuscularly, administered 1 hour before surgery

bucain + fentanyl

Intervention Type: DRUG

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

Nalbuphine

Intervention Type: DRUG

1st choice for rescue analgetic 10-20 mg intravenously

Diclofenac

Intervention Type: DRUG

2nd choice for rescue analgetic 250ml intravenously

Metamizole-sodium

Intervention Type: DRUG

Additional rescue analgetic 2g intravenously

Tramadol

Intervention Type: DRUG

Additional rescue analgetic 100mg intravenously

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.

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

5 mg Dormicum intramuscularly, administered 1 hour before surgery

Atropine

Intervention Type: DRUG

0.5 mg Atropine intramuscularly, administered 1 hour before surgery

bucain + fentanyl

Intervention Type: DRUG

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

Nalbuphine

Intervention Type: DRUG

1st choice for rescue analgetic 10-20 mg intravenously

Diclofenac

Intervention Type: DRUG

2nd choice for rescue analgetic 250ml intravenously

Metamizole-sodium

Intervention Type: DRUG

Additional rescue analgetic 2g intravenously

Tramadol

Intervention Type: DRUG

Additional rescue analgetic 100mg intravenously

Interventions

Diclofenac

Orally 100 mg Diclofenac, administered 1 hour before surgery

Intervention Type: DRUG

Midazolam

5 mg Dormicum intramuscularly, administered 1 hour before surgery

Intervention Type: DRUG

Atropine

0.5 mg Atropine intramuscularly, administered 1 hour before surgery

Intervention Type: 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.

Intervention Type: DRUG

Nalbuphine

1st choice for rescue analgetic 10-20 mg intravenously

Intervention Type: DRUG

Diclofenac

2nd choice for rescue analgetic 250ml intravenously

Intervention Type: DRUG

Metamizole-sodium

Additional rescue analgetic 2g intravenously

Intervention Type: DRUG

Tramadol

Additional rescue analgetic 100mg intravenously

Intervention Type: DRUG

Other Intervention Names

Diclofenac Stada 100 mg retard; Dormicum 5mg/ml; Atropine 1 mg/ml; Nubain 20mg/2ml; Neodolpasse 75 mg/ 250ml; Algopyrin 2g/2ml; Contramal 100mg/2ml

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Debrecen

OTHER

Sponsor Role: lead

Responsible Party

Tamas Vegh, MD

MD, PhD assistant professor anesthesiologist and intensive care specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Béla Fülesdi, MD,PhD,DSci

Role: PRINCIPAL_INVESTIGATOR

UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032

Locations

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

Debrecen, Hajdú-Bihar, Hungary

Countries

Hungary

References

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

Reference Type: BACKGROUND

PMID: 18456219 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16508407 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17004557 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15707349 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3078045 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11394926 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22678319 (View on PubMed)

Other Identifiers

DEOEC RKEB/IKEB 4044-2013

Identifier Type: -

Identifier Source: org_study_id