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

NCT02445599 | Completed Phase 4 DMC

• 1 other identifier: DEOEC RKEB/IKEB 4044-2013
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Inadequate or Impaired Respiratory Function

Keywords

thoracotomy; pain management; analgesia; postoperative care; premedication; preventive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 10% reduction of the shoulder pain recorded by VAS score.

  5 days

Other Outcomes (5)

• Analgetic need during the first five postoperative days.

  Participants were followed for 5 days postoperatively

• Postoperative complications during the first five postoperative days

  Participants were followed for 5 days postoperatively

• Intraoperative fentanyl use

  Participants were followed during the operation on day 1

Study Arms (2)

Diclofenac group

EXPERIMENTAL

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; Drug: Midazolam; Drug: Atropine; Drug: bucain + fentanyl; Drug: Nalbuphine; Drug: Metamizole-sodium; Drug: Tramadol

Control group

EXPERIMENTAL

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

Interventions

Diclofenac DRUG

Orally 100 mg Diclofenac, administered 1 hour before surgery

Also known as: Diclofenac Stada 100 mg retard

Diclofenac group

Midazolam DRUG

5 mg Dormicum intramuscularly, administered 1 hour before surgery

Also known as: Dormicum 5mg/ml

Control group; Diclofenac group

Atropine DRUG

0.5 mg Atropine intramuscularly, administered 1 hour before surgery

Also known as: Atropine 1 mg/ml

Control group; Diclofenac group

bucain + fentanyl DRUG

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

Control group; Diclofenac group

Nalbuphine DRUG

1st choice for rescue analgetic 10-20 mg intravenously

Also known as: Nubain 20mg/2ml

Control group; Diclofenac group

Metamizole-sodium DRUG

Additional rescue analgetic 2g intravenously

Also known as: Algopyrin 2g/2ml

Control group; Diclofenac group

Tramadol DRUG

Additional rescue analgetic 100mg intravenously

Also known as: Contramal 100mg/2ml

Control group; Diclofenac group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• acute operation
• diclofenac allergy in the anamnesis
• the lack of thoracic epidural cannula

Sponsors & Collaborators

• University of Debrecen: lead

Study Sites (1)

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

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Related 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.

  PMID: 18456219 BACKGROUND

• 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.

  PMID: 16508407 BACKGROUND

• 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.

  PMID: 17004557 BACKGROUND

• 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.

  PMID: 15707349 BACKGROUND

• 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.

  PMID: 3078045 BACKGROUND

• 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.

  PMID: 11394926 BACKGROUND

• 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.

  PMID: 22678319 RESULT

MeSH Terms

Conditions

Pain; Respiratory Insufficiency; Agnosia

Interventions

Diclofenac; Midazolam; Atropine; bucain; Fentanyl; Nalbuphine; Neodolpasse; Dipyrone; Tramadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Piperidines; Heterocyclic Compounds, 1-Ring; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Béla Fülesdi, MD,PhD,DSci

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD assistant professor anesthesiologist and intensive care specialist

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: May 15, 2015
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

HU (1)