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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.
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.:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac | Drug | Orally 100 mg Diclofenac, administered 1 hour before surgery |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Béla Fülesdi, MD,PhD,DSci | UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18456219 | Background | Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007. | |
| 16508407 | 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. |
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| Midazolam | Drug | 5 mg Dormicum intramuscularly, administered 1 hour before surgery |
|
|
| Atropine | Drug | 0.5 mg Atropine intramuscularly, administered 1 hour before surgery |
|
|
| 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. |
|
| Nalbuphine | Drug | 1st choice for rescue analgetic 10-20 mg intravenously |
|
|
| Diclofenac | Drug | 2nd choice for rescue analgetic 250ml intravenously |
|
|
| Metamizole-sodium | Drug | Additional rescue analgetic 2g intravenously |
|
|
| Tramadol | Drug | Additional rescue analgetic 100mg intravenously |
|
|
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 |
| 17004557 | 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. |
| 15707349 | 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. |
| 3078045 | 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. |
| 11394926 | 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. |
| 22678319 | Result | 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. |
| ID | Term |
|---|---|
| D010146 | Pain |
| D012131 | Respiratory Insufficiency |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D008874 | Midazolam |
| D001285 | Atropine |
| C472824 | bucain |
| D005283 | Fentanyl |
| D009266 | Nalbuphine |
| C487365 | Neodolpasse |
| D004177 | Dipyrone |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000632 | Aminopyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
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