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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000900415
Enrollment
120
Registered
2016-07-07
Start date
2016-07-26
Completion date
2017-10-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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

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.

Sponsors

Medical University of Lublin
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Elective thoracotomy surgery

Exclusion criteria

No consent obtained Coagulopathy Poorly-controlled diabetes mellitus Depression or other psychiatric disorders which requiered antidepressant drugs Alcohol or recreational drugs addiction

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026