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

Primary Purpose

Pain, Inadequate or Impaired Respiratory Function

Status
Completed
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
Diclofenac
Midazolam
Atropine
bucain + fentanyl
Nalbuphine
Diclofenac
Metamizole-sodium
Tramadol
Sponsored by
University of Debrecen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring thoracotomy, pain management, analgesia, postoperative care, premedication, preventive

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Diclofenac group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 11, 2014
Last Updated
March 8, 2017
Sponsor
University of Debrecen
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1. Study Identification

Unique Protocol Identification Number
NCT02445599
Brief Title
Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Debrecen

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Inadequate or Impaired Respiratory Function
Keywords
thoracotomy, pain management, analgesia, postoperative care, premedication, preventive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diclofenac group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Other Intervention Name(s)
Diclofenac Stada 100 mg retard
Intervention Description
Orally 100 mg Diclofenac, administered 1 hour before surgery
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Dormicum 5mg/ml
Intervention Description
5 mg Dormicum intramuscularly, administered 1 hour before surgery
Intervention Type
Drug
Intervention Name(s)
Atropine
Other Intervention Name(s)
Atropine 1 mg/ml
Intervention Description
0.5 mg Atropine intramuscularly, administered 1 hour before surgery
Intervention Type
Drug
Intervention Name(s)
bucain + fentanyl
Intervention Description
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
Intervention Name(s)
Nalbuphine
Other Intervention Name(s)
Nubain 20mg/2ml
Intervention Description
1st choice for rescue analgetic 10-20 mg intravenously
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Other Intervention Name(s)
Neodolpasse 75 mg/ 250ml
Intervention Description
2nd choice for rescue analgetic 250ml intravenously
Intervention Type
Drug
Intervention Name(s)
Metamizole-sodium
Other Intervention Name(s)
Algopyrin 2g/2ml
Intervention Description
Additional rescue analgetic 2g intravenously
Intervention Type
Drug
Intervention Name(s)
Tramadol
Other Intervention Name(s)
Contramal 100mg/2ml
Intervention Description
Additional rescue analgetic 100mg intravenously
Primary Outcome Measure Information:
Title
10% reduction of the thoracotomy pain recorded by VAS score.
Description
Our main goal is to achieve 10% reduction of the thoracotomy pain recorded by VAS score, compared to the non-diclofenac control group.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
10% reduction of the shoulder pain recorded by VAS score.
Description
Our second goal is to achieve 10%reduction of the shoulder pain recorded by VAS score, compared to the non-diclofenac control group.
Time Frame
5 days
Other Pre-specified Outcome Measures:
Title
Analgetic need during the first five postoperative days.
Description
The total amount of administered analgetics were recorded during the first five postoperative days and then converted into intramuscular morphine equivalents.
Time Frame
Participants were followed for 5 days postoperatively
Title
Postoperative complications during the first five postoperative days
Description
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.
Time Frame
Participants were followed for 5 days postoperatively
Title
Intraoperative fentanyl use
Description
Intraoperative fentanyl use was registered as micrograms per kilogram body weight and micrograms per hour as well.
Time Frame
Participants were followed during the operation on day 1
Title
Epidurally administered local anethetics
Description
The total amount of epidurally administered local anesthetic were recorded during the first five postoperative days.
Time Frame
Participants were followed for 5 days postoperatively
Title
Comparing the pre- and postoperative lung function test values
Description
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.
Time Frame
Participants were followed for 5 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Béla Fülesdi, MD,PhD,DSci
Organizational Affiliation
UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care
City
Debrecen
State/Province
Hajdú-Bihar
ZIP/Postal Code
4032
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
18456219
Citation
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Results Reference
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PubMed Identifier
16508407
Citation
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.
Results Reference
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PubMed Identifier
17004557
Citation
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.
Results Reference
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PubMed Identifier
15707349
Citation
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.
Results Reference
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PubMed Identifier
3078045
Citation
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.
Results Reference
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PubMed Identifier
11394926
Citation
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.
Results Reference
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PubMed Identifier
22678319
Citation
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.
Results Reference
result

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

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