Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.:
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Study Group: 100mg diclofenac per os (n=50)
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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 Design
Arms and Interventions
| 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:
Drug: Midazolam
5 mg Dormicum intramuscularly, administered 1 hour before surgery
Other Names:
Drug: Atropine
0.5 mg Atropine intramuscularly, administered 1 hour before surgery
Other Names:
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:
Drug: Diclofenac
2nd choice for rescue analgetic 250ml intravenously
Other Names:
Drug: Metamizole-sodium
Additional rescue analgetic 2g intravenously
Other Names:
Drug: Tramadol
Additional rescue analgetic 100mg intravenously
Other Names:
|
| 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: Midazolam
5 mg Dormicum intramuscularly, administered 1 hour before surgery
Other Names:
Drug: Atropine
0.5 mg Atropine intramuscularly, administered 1 hour before surgery
Other Names:
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:
Drug: Diclofenac
2nd choice for rescue analgetic 250ml intravenously
Other Names:
Drug: Metamizole-sodium
Additional rescue analgetic 2g intravenously
Other Names:
Drug: Tramadol
Additional rescue analgetic 100mg intravenously
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 10% reduction of the thoracotomy pain recorded by VAS score. [5 days]
Our main goal is to achieve 10% reduction of the thoracotomy pain recorded by VAS score, compared to the non-diclofenac control group.
Secondary Outcome Measures
- 10% reduction of the shoulder pain recorded by VAS score. [5 days]
Our second goal is to achieve 10%reduction of the shoulder pain recorded by VAS score, compared to the non-diclofenac control group.
Other Outcome Measures
- Analgetic need during the first five postoperative days. [Participants were followed for 5 days postoperatively]
The total amount of administered analgetics were recorded during the first five postoperative days and then converted into intramuscular morphine equivalents.
- Postoperative complications during the first five postoperative days [Participants were followed for 5 days postoperatively]
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.
- Intraoperative fentanyl use [Participants were followed during the operation on day 1]
Intraoperative fentanyl use was registered as micrograms per kilogram body weight and micrograms per hour as well.
- Epidurally administered local anethetics [Participants were followed for 5 days postoperatively]
The total amount of epidurally administered local anesthetic were recorded during the first five postoperative days.
- Comparing the pre- and postoperative lung function test values [Participants were followed for 5 days postoperatively]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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100 thoracotomy patients who agreed to take part in our study and signed a consent
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age 18-80 years
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ASA I-III
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men/women equally
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thoracotomies are managed with using intratracheal double lumen tube
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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:
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acute operation
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diclofenac allergy in the anamnesis
-
the lack of thoracic epidural cannula
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care | Debrecen | Hajdú-Bihar | Hungary | 4032 |
Sponsors and Collaborators
- University of Debrecen
Investigators
- Principal Investigator: Béla Fülesdi, MD,PhD,DSci, UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032
Study Documents (Full-Text)
None provided.More Information
Publications
- Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007. Review.
- 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.
- Gottschalk A, Cohen SP, Yang S, Ochroch EA. Preventing and treating pain after thoracic surgery. Anesthesiology. 2006 Mar;104(3):594-600. Review.
- Koehler RP, Keenan RJ. Management of postthoracotomy pain: acute and chronic. Thorac Surg Clin. 2006 Aug;16(3):287-97. Review.
- McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. Review.
- 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.
- DEOEC RKEB/IKEB 4044-2013