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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Inadequate or Impaired Respiratory Function
• Intervention / Treatment: Drug: Diclofenac; Drug: Midazolam; Drug: Atropine; Drug: bucain + fentanyl; Drug: Nalbuphine; Drug: Diclofenac; Drug: Metamizole-sodium; Drug: Tramadol

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hungary
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Diclofenac; Orally 100 mg Diclofenac, administered 1 hour before surgery; Other Names: Diclofenac Stada 100 mg retard; Drug: Midazolam; 5 mg Dormicum intramuscularly, administered 1 hour before surgery; Other Names: Dormicum 5mg/ml; Drug: Atropine; 0.5 mg Atropine intramuscularly, administered 1 hour before surgery; Other Names: Atropine 1 mg/ml; 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.; Drug: Nalbuphine; 1st choice for rescue analgetic 10-20 mg intravenously; Other Names: Nubain 20mg/2ml; Drug: Diclofenac; 2nd choice for rescue analgetic 250ml intravenously; Other Names: Neodolpasse 75 mg/ 250ml; Drug: Metamizole-sodium; Additional rescue analgetic 2g intravenously; Other Names: Algopyrin 2g/2ml; Drug: Tramadol; Additional rescue analgetic 100mg intravenously; Other Names: Contramal 100mg/2ml
Experimental: 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.	Drug: Diclofenac; Orally 100 mg Diclofenac, administered 1 hour before surgery; Other Names: Diclofenac Stada 100 mg retard; Drug: Midazolam; 5 mg Dormicum intramuscularly, administered 1 hour before surgery; Other Names: Dormicum 5mg/ml; Drug: Atropine; 0.5 mg Atropine intramuscularly, administered 1 hour before surgery; Other Names: Atropine 1 mg/ml; 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.; Drug: Nalbuphine; 1st choice for rescue analgetic 10-20 mg intravenously; Other Names: Nubain 20mg/2ml; Drug: Diclofenac; 2nd choice for rescue analgetic 250ml intravenously; Other Names: Neodolpasse 75 mg/ 250ml; Drug: Metamizole-sodium; Additional rescue analgetic 2g intravenously; Other Names: Algopyrin 2g/2ml; Drug: Tramadol; Additional rescue analgetic 100mg intravenously; Other Names: Contramal 100mg/2ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Debrecen
• Investigators: Principal Investigator: Bela Fulesdi, MD,PhD,DSci, UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: analgesia; thoracotomy; postoperative care; premedication; pain management; preventive
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Respiratory Insufficiency; Shoulder Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Fentanyl; Midazolam; Diclofenac; Tramadol; Atropine; Nalbuphine; Dipyrone
• Other Study ID Numbers: DEOEC RKEB/IKEB 4044-2013