Effect of Epidural Anesthesia and Analgesia on Quality of Recovery After Radical Prostatectomy.

Study Overview
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Brief Summary
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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.

Detailed Description
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All participants were premedicated with diazepam 5 mg 12 hours and 1 hour before surgery. Thromboprophylaxis ( 4,000 - 6000 IU) depending on the body weight was given at least 12 hours before surgery. All participants were warmed to prevent unintended hypothermia. Participants were allocated by permuted block randomisation into one of two groups: general anesthesia group and epidural anesthesia. The randomisation list was obtained from R program version 3.5.3. The group allocations were contained in a closed envelope that were opened before surgery after the completed enrollment procedure. All patients and infusions were wormed to prevent unintended hypothermia. Induction of general anesthesia was with midazolam 2.5 mg, fentanyl 100 μg, propofol 1-2 mg/kg and vecuronium 0.1 mg/kg. Balanced crystalloid fluids were used to treat hypovolemia. Additionally, 6% Hydroxyethyl starch was used before blood transfusion products to treat profound hypovolemia. Blood transfusions were given according to blood loss and clinical situation. Bradycardia was treated with atropine. Hypotension was treated with ephedrine boluses. Anti-inflammatory drug metamizole (dipyrone) 2.5 g was given intravenously before the end of the surgery and after 12 hours after the surgery. Neostigmine 2.5 mg with atropine 1 mg was used for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Participants were placed for one day in a urology high care unit provided with constant and vigilant nurse care. Crystalloid infusions were used for maintaining diuresis. Gastroprotection was done with pantoprazole 40 mg. Metoclopramid 10 mg was given for postoperative nausea and vomiting (PONV). The postoperative QoR was evaluated with three QoR scales. Scales for pain, anxiety and PONV were also examined. The 36-Item Short Form Survey (SF-36) questionnaire evaluated quality of life one month before and one month after surgery.

Official Title
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Is Postoperative Quality of Recovery After Radical Prostatectomy Related to the Type of Anesthesia and Analgesia?

Conditions
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Anesthesia, Anesthesia Recovery Period, Radical Prostatectomy, Patient Satisfaction, Postoperative Period, Quality of Life, Analgesia, Epidural, Quality of Recovery

Intervention / Treatment
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* Procedure: Epidural anesthesia with light general anesthesia
* Drug: Postoperative epidural analgesia
* Procedure: General anesthesia
* Drug: Continuous intravenous analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural anesthesia and analgesia<br>Epidural catheter insertion: Th 12- L 1 or Th 11 - Th 12 using the midline approach. Safety of the epidural catheter was confirmed with lidocaine 60 mg. Epidural loading dose was given according to our classification (3,4,5 or 6 ml). Postoperative period in urology high care unit. Epidural analgesia ropivacaine/morphine was administered by a urologist according to our classification (2x2 ml, 2x3 ml and 3x3 ml). | Procedure: Epidural anesthesia with light general anesthesia<br>* Epidural anaesthesia: mixture of ropivacaine 6.5 mg/ ml and fentanyl 8.3 μg/ml. Light general anesthesia: isoflurane in mixture of 50/50 of nitrous oxide and oxygen to achieve Minimum alveolar concentration between 0.6 and 0.8.<br>Drug: Postoperative epidural analgesia<br>* Before the end of operation was given 4 ml of the mixture of ropivacaine 4.4 mg/ml and morphine 0.8mg/ ml. Epidural analgesia was continued for next 24 hours with a mixture of ropivacaine 2.2 mg/ml and morphine 0.4 mg/ml.<br>* Other names: Epidural analgesia with morphine and ropivacaine;|
| Active Comparator: Balanced general anesthesia and tramadol analgesia<br>Postoperative period in urology high care unit. | Procedure: General anesthesia<br>* Maintaining general anesthesia: nitrous oxide and oxygen in mixture 50/50 and isoflurane to achieve minimum alveolar concentration between 0.8 and 1. Fentanyl loading dose: 6-8 μg/kg. Additional fentanyl doses were given incrementally.<br>Drug: Continuous intravenous analgesia<br>* Tramadol 100 mg in the first hour followed by tramadol 300 mg continuously for the next 24 hours.<br>* Other names: Continuous tramadol infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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] | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General anesthesia, Combined light general and epidural Anesthesia, Health related quality of life, Radical prostatectomy