Effect of Epidural Anesthesia and Analgesia on Quality of Recovery After Radical Prostatectomy.
Condition: Anesthesia; Anesthesia Recovery Period; Radical Prostatectomy; Patient Satisfaction; Postoperative Period; Quality of Life; Analgesia; Epidural; Quality of Recovery
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Epidural anesthesia with light general anesthesia; Postoperative epidural analgesia; General anesthesia; Continuous intravenous analgesia
Intervention type(s): Procedure; Drug; Procedure; Drug
Intervention description(s): 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.; 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.; 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.; Tramadol 100 mg in the first hour followed by tramadol 300 mg continuously for the next 24 hours.
Other intervention name(s): Epidural analgesia with morphine and ropivacaine; Continuous tramadol infusion
Intervention MeSH terms: Morphine; Tramadol; Anesthetics; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: General anesthesia; Combined light general and epidural Anesthesia; Health related quality of life; Radical prostatectomy