Quality of Life Clinical Trial
— QoROfficial title:
Is Postoperative Quality of Recovery After Radical Prostatectomy Related to the Type of Anesthesia and Analgesia?
Verified date | September 2021 |
Source | University Hospital of Split |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Postoperative quality of recovery (QoR) could be related to anesthesia and postoperative analgesia. This study is exploring early QoR after radical prostatectomy in the two groups of anesthesia. The first group had a light general anesthesia with lumbal epidural anesthesia and postoperative epidural analgesia with morphine and ropivacaine. The second group had general anesthesia and a continuous postoperative analgesia with tramadol. The postoperative QoR was evaluated 24 hours after surgery.
Status | Completed |
Enrollment | 61 |
Est. completion date | June 1, 2021 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Elective radical Prostatectomy. - American Society of Anesthesiologists (ASA) physical status classification system: I, II, III Exclusion Criteria: Dementia - Delirium - Acute psychosis - Emergent surgery - Hospitalisation in Intensive care unit - American Society of Anesthesiologists (ASA) physical status classification system: IV - Reoperations - Muscular diseases - Montreal cognitive test <24 points - Contraindications for epidural anesthesia |
Country | Name | City | State |
---|---|---|---|
Croatia | University Hospital Split | Split |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Split |
Croatia,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual analog scale of quality of recovery (QoR) | Patient rated visual analog scale is a simple scale for rating the quality of recovery by placing "X" on the line. The scale is 100 millimetres long. Poor recovery is on the left side of the line. Under the end of the left line is an explanation of poor recovery: in severe pain,nausea & vomiting, confused, immobilized, unable to eat and unable to communicate. Excellent recovery is on the right side of the line. Under the end of the line is a written explanation: without any pain, comfortable, alert, active, enjoying food and communicating freely. | 24 hours after surgery | |
Primary | Quality of recovery 40 (QoR-40) | The QoR-40 measures five related dimensions of quality of recovery: emotional state (8 items), physical comfort (12 items), physical independence (5 items), psychological support (7 items) and pain (7 items). Each item is rated on a 5 point Likert scale. Minimal possible score is 40 and maximal possible score is 200. | 24 hours after surgery | |
Primary | Quality of recovery 15 (QoR-15) | Quality of recovery (QoR-15) is a short version of QoR - 40 questionnaire. The QoR-15 questionnaire has 15 items scaled from 0 to 10. Minimum score is 0, and maximum 150. It is shorter, user friendly and less time consuming then extensive QoR-40 questionnaire. | 24 hours after surgery | |
Secondary | Visual analog scale of pain- at rest and during coughing and straining | Patient rated visual analog pain scale is a simple scale for rating the pain intensity by placing "X" on the line. The scale is 100 millimetres long. No pain at all is written on the left side of the line and will correspond to 0 millimetres. The worst possible pain is on the right side of the line. The worst possible pain will correspond to 100 millimetres. It is important to asses pain intensity at rest and pain intensity during activity (coughing, straining or getting up from bed ). | 24 hours after surgery | |
Secondary | Numerical pain scale - at rest and during coughing and straining | Similar to the visual analog scale of pain, but instead of line, it consists of a sequence of numbers (0-10). For some participants, scaling pain in numbers (0-10) is more clear than analog scale. No pain will at all will correspond to 0 and the worst possible pain will correspond to 10. It is important to asses pain intensity at rest and pain intensity during activity (coughing, straining or getting up from bed ). | 24 hours after surgery | |
Secondary | Visual pain scale with faces- at rest and during coughing and straining | Similar to the numeric pain scale. If pain scaling in numbers is vaguely, then six faces with emotional expression ranging from a happy smiling to a crying face with tears explain numbers under the faces (0,2,4,6,8,10). It was designated for children. No pain will at all will correspond to 0 and the worst possible pain will correspond to 10. It is important to asses pain intensity at rest and pain intensity during activity (coughing, straining or getting up from bed ). | 24 hours after surgery | |
Secondary | Visual analog scale of anxiety | Patient rated visual analog scale is a simple scale for rating the level of anxiety by placing "X" on the line. The scale is 100 millimetres long. No anxiety at all is written on the left side of the line. No anxiety at all will correspond to 0 millimetres. The worst possible anxiety is on the right side of the line.The worst possible pain will correspond to 100 millimetres. | 24 hours after surgery | |
Secondary | Numerical anxiety scale | Similar to the visual analog scale of anxiety, but instead of line, it consists of a sequence of numbers (0-10). For some participants, scaling in numbers (0-10) is more clear than analog scale. No anxiety at all will correspond to 0 and the worst possible anxiety will correspond to 10. | 24 hours after surgery | |
Secondary | Visual anxiety scale with faces | Similar to the numerical anxiety scale. For some patients quantifying pain in numbers is vague, but if they can observe faces with different emotional expressions ranging from a happy smiling to a crying face with tears. Under the faces are written corresponding numbers (0,2,4,6,8,10). No anxiety at all will correspond to 0 and the worst possible anxiety will correspond to 10. | 24 hours after surgery | |
Secondary | The short form health survey version one (SF-36:I) | The short form health survey version one (SF-36:I.) measure eight dimensions of quality of life: physical functioning (10 items), role limitation due to physical problems (4 items), bodily pain (2 items), social functioning (2 items), mental health (5 items), role limitation due to emotional problems (3 items), vitality (4 items) and general health perception (5 items). Each dimension has a possible score of 0 (poor health) to 100 (excellent health). | 24 hours after surgery and one month after surgery] | |
Secondary | Simplified postoperative nausea and vomiting (PONV) impact scale | PONV impact scale consists of 2 questions that are scored from 0 to 3. Five points or six defines clinically important PONV. | 24 hours after surgery | |
Secondary | Global visual analog and numeric scale of nausea intensity | Scale for rating the nausea intensity by placing "X" on the line. No nausea at all is written on the left side of the line. The worst possible nausea experienced is on the right side of the line. Under the line are written numbers (0-10). No nausea at all will correspond to 0 and the worst possible nausea will correspond to 10. | 24 hours after surgery |
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