RecruitingPhase 4ACTRN12616000900415

Pain treatment after open-chest operations with three possibilities of pain-relief therapy.

The assessment of various types of perioperative analgesia after the thoracotomy.


Sponsor

Medical University of Lublin

Enrollment

120 participants

Start Date

Jul 26, 2016

Study Type

Interventional

Conditions

Summary

The main aim of the study is assessment of three types of analgesic approach in patients after thoracotomy. The secondary aim is evaluation of neurophatic pain 1, 3 and 6 months after surgery.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is comparing three different pain relief approaches for people who have undergone open chest surgery (thoracotomy). After chest surgery, pain can be severe and long-lasting, sometimes becoming a chronic problem. The three pain relief methods being compared will be evaluated immediately after surgery and at 1, 3, and 6 months afterwards to see which works best for short-term and long-term pain, including nerve-related (neuropathic) pain. You may be eligible if: - You are between 18 and 75 years old - You are scheduled for elective (planned) open chest surgery (thoracotomy) - You are able to give informed consent You may NOT be eligible if: - You have not given consent - You have a bleeding disorder - You have poorly controlled diabetes - You have depression or another psychiatric disorder requiring antidepressants - You have an addiction to alcohol or recreational drugs Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

All patients participated in the study will receive morphine in postoperative period. Pain will be measured with visual-analogue scale (VAS) during 24 hours after surgery as well as morphine consumpti

All patients participated in the study will receive morphine in postoperative period. Pain will be measured with visual-analogue scale (VAS) during 24 hours after surgery as well as morphine consumption will be noted. Morphine will be administered with patient-controlled analgesia devices (PCA). Each patient participated in the study will be aneasthetised in the same manner. Total intravenous anaesthesia approach: propofol, fentanyl, rocuronium. Other drugs (atropine, neostigmine, ondansetron) will be given as required. 30 minutes before the end of surgery, all patients will receive bolus of morphine ( 0.1-0,15 mg/kg) and 2 grams of metamizol intravenously. In postoperative period each patient will get metamizol (every 6 h). When pain increases above 40 in VAS, patients will receive 5 mg of morphine. Ondansetron will be given as required due to nausea and vomiting. Patients will be randomly assigned to one of the treated groups (i.e. contrainication to paravertebral catheter placement or allergy to any of drugs will exclude a patient from the study). First group: before the surgery paravertebral catheter will be placed. Each patient in this group will receive 30 ml of local anaesthetic solution (0,25% bupivacaine with 2 mcg of fentanyl per ml) at the end of operation. After the emergence from general anaesthesia the infusion of local anesthetic solution will be continued (0.1 ml/kg/h) for 24 h. Second group: after induction of general anaesthesia, but before the first incision, patients in this group will receive i.v. injection of ketamine (1 mg/kg) Third group (control group): only morphine and metamizol will be given in postoperative period as pain-relief drugs (standard care). 1,2 and 6 months after the surgery neuropathic pain will be assesed. Each patient participated in the study will be called and NPSI (Neuropathic Pain Symptom Inventory) will be used to measure pain.


Locations(1)

Poland

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ACTRN12616000900415