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

University of Debrecen

Status and phase: Completed; Phase 4

Conditions: Pain; Inadequate or Impaired Respiratory Function

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02445599

DEOEC RKEB/IKEB 4044-2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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3 participants in 2 patient groups

Diclofenac group

Experimental group

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.

Treatment:

Drug: Tramadol

Drug: Atropine

Drug: Diclofenac

Drug: Diclofenac

Drug: Metamizole-sodium

Drug: Midazolam

Drug: bucain + fentanyl

Drug: Nalbuphine

Control group

Experimental group

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.

Treatment:

Drug: Tramadol

Drug: Atropine

Drug: Diclofenac

Drug: Diclofenac

Drug: Metamizole-sodium

Drug: Midazolam

Drug: bucain + fentanyl

Drug: Nalbuphine