Clinical trial NCT04587505: Effect of Epidural Anesthesia and Analgesia on Quality of Recovery After Radical Prostatectomy.
Official title: Is Postoperative Quality of Recovery After Radical Prostatectomy Related to the Type of Anesthesia and Analgesia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Anesthesia Recovery Period
Radical Prostatectomy
Patient Satisfaction
Postoperative Period
Quality of Life
Analgesia
Epidural
Quality of Recovery
Keywords: General anesthesia
Combined light general and epidural Anesthesia
Health related quality of life
Radical prostatectomy
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 61
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analog scale of quality of recovery (QoR)
timeFrame: 24 hours after surgery
measure: Quality of recovery 40 (QoR-40)
timeFrame: 24 hours after surgery
measure: Quality of recovery 15 (QoR-15)
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Visual analog scale of pain- at rest and during coughing and straining
timeFrame: 24 hours after surgery
measure: Numerical pain scale - at rest and during coughing and straining
timeFrame: 24 hours after surgery
measure: Visual pain scale with faces- at rest and during coughing and straining
timeFrame: 24 hours after surgery
measure: Visual analog scale of anxiety
timeFrame: 24 hours after surgery
measure: Numerical anxiety scale
timeFrame: 24 hours after surgery
measure: Visual anxiety scale with faces
timeFrame: 24 hours after surgery
measure: The short form health survey version one (SF-36:I)
timeFrame: 24 hours after surgery and one month after surgery]
measure: Simplified postoperative nausea and vomiting (PONV) impact scale
timeFrame: 24 hours after surgery
measure: Global visual analog and numeric scale of nausea intensity
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University Hospital Split
Study officials:
affiliation: University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia
name: Ruben Kovac
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Center Split, Department of Anesthesiology and Intensive Care, Split, Croatia
name: Bozidar Duplancic
role: STUDY_CHAIR
affiliation: University Hospital Split, Department of Urology
name: Ivo Juginovic
role: STUDY_CHAIR
affiliation: University Hospital Center Split, Department of Urology, Split, Croatia
name: Ivan Velat
role: STUDY_CHAIR
affiliation: University Hospital Center Split, Department of Anesthesiology and Intensive Care, Split, Croatia
name: Hrvoje Vucemilovic
role: STUDY_CHAIR
affiliation: University Hospital Center Split, Department of Anesthesiology and Intensive Care, Split, Croatia
name: Svjetlana Dosenovic
role: STUDY_CHAIR
References:
citation: Greg Snow (2020) blockrand: Randomization for Block Random Clinical Trials. R package version 1.5. https://CRAN.R-project.org/package=blockrand
citation: Stamer UM, Hothker F, Lehnen K, Stuber F. [Postoperative analgesia with tramadol and metamizol. Continual infusion versus patient controlled analgesia]. Anaesthesist. 2003 Jan;52(1):33-41. doi: 10.1007/s00101-002-0427-1. German.
citation: Myles PS. Measuring quality of recovery in perioperative clinical trials. Curr Opin Anaesthesiol. 2018 Aug;31(4):396-401. doi: 10.1097/ACO.0000000000000612.
citation: Gornall BF, Myles PS, Smith CL, Burke JA, Leslie K, Pereira MJ, Bost JE, Kluivers KB, Nilsson UG, Tanaka Y, Forbes A. Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth. 2013 Aug;111(2):161-9. doi: 10.1093/bja/aet014. Epub 2013 Mar 6.
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