Is Postoperative Quality of Recovery After Radical Prostatectomy Related to the Type of Anesthesia and Analgesia?
Overview
- Phase
- Phase 4
- Intervention
- Epidural anesthesia with light general anesthesia
- Conditions
- Anesthesia
- Sponsor
- University Hospital of Split
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Quality of recovery 15 (QoR-15)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Ruben Kovac
Principal Investigator
University Hospital of Split
Eligibility Criteria
Inclusion Criteria
- •Elective radical Prostatectomy.
- •American Society of Anesthesiologists (ASA) physical status classification system: I, II, III
Exclusion Criteria
- •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
Arms & Interventions
Epidural anesthesia and analgesia
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).
Intervention: Epidural anesthesia with light general anesthesia
Epidural anesthesia and analgesia
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).
Intervention: Postoperative epidural analgesia
Balanced general anesthesia and tramadol analgesia
Postoperative period in urology high care unit.
Intervention: General anesthesia
Balanced general anesthesia and tramadol analgesia
Postoperative period in urology high care unit.
Intervention: Continuous intravenous analgesia
Outcomes
Primary Outcomes
Quality of recovery 15 (QoR-15)
Time Frame: 24 hours after surgery
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.
Visual analog scale of quality of recovery (QoR)
Time Frame: 24 hours after surgery
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.
Quality of recovery 40 (QoR-40)
Time Frame: 24 hours after surgery
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.
Secondary Outcomes
- Visual analog scale of pain- at rest and during coughing and straining(24 hours after surgery)
- Simplified postoperative nausea and vomiting (PONV) impact scale(24 hours after surgery)
- Numerical pain scale - at rest and during coughing and straining(24 hours after surgery)
- Global visual analog and numeric scale of nausea intensity(24 hours after surgery)
- Visual pain scale with faces- at rest and during coughing and straining(24 hours after surgery)
- Visual analog scale of anxiety(24 hours after surgery)
- Visual anxiety scale with faces(24 hours after surgery)
- Numerical anxiety scale(24 hours after surgery)
- The short form health survey version one (SF-36:I)(24 hours after surgery and one month after surgery])