Lung Cancer Clinical Trial
Official title:
Postoperative Pain After Single Port, Two Ports and Three Ports Video-assisted Thoracic Surgery Lobectomy in Cancer Patients: A Randomized Controlled Trial
This single-center, prospective, randomized controlled trial was designed to assess and compare the postoperative pain after VATS lobectomy performed though one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measure is cumulative morphine consumption up to 72 hours after surgery
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) physical status 1-3 2. undergo videothoracoscopic lung lobectomy 3. forced expiratory volume in 1 second (FEV1) >1,5 l/min 4. no contraindications for epidural anesthesia 5. ability to comprehend principles of VAS pain examination method and to communicate in accordance with them. Exclusion Criteria: 1. prior to the study: contraindications for local anesthesia, ASA>3, FEV1<1,5 l/min, conditions disabling the patient from comprehending the principles of VAS pain examination, known allergy to used medications. 2. during the study: failure to place epidural catheter, decision to abandon lobar resection (e.g. in case of neoplastic dissemination), intraoperative conversion to thoracotomy, intraoperative anatomical obstacles to distribution of local anesthetics, conditions disabling the patient from pain evaluation by means of VAS method (e.g. postoperative delirium), necessity to administer other pharmaceuticals influencing pain perception (e.g. sedatives), necessity of mechanical ventilation, interruption of local anesthesia as a result of technical problems (e.g. damage or slippage of catheter). |
Country | Name | City | State |
---|---|---|---|
Poland | Pulmonary Hospital | Zakopane | Malopolska |
Poland | Pulmonary Hospital | Zakopane |
Lead Sponsor | Collaborator |
---|---|
Pulmonary Hospital Zakopane |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain intensity | 0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery | up to 72 hours after the end of surgery | |
Secondary | opioid consumption | cumulative rescue morphine consumtion (PCA) in miligrams | up to 72 hours after the end of surgery | |
Secondary | rate of complications | frequency of postoperative complications (atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiatory depression, sedation) | up to 72 hours after the end of surgery |
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