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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Analgesia; Anesthesia; Patient Satisfaction; Quality of Recovery; Anesthesia Recovery Period; Epidural; Postoperative Period; Radical Prostatectomy
• Intervention / Treatment: Procedure: Epidural anesthesia with light general anesthesia; Drug: Postoperative epidural analgesia; Procedure: General anesthesia; Drug: Continuous intravenous analgesia

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

Study Locations

• Croatia
  • Split, Croatia, 21000
    • University Hospital Split

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Procedure: Epidural anesthesia with light general anesthesia; 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.; Drug: Postoperative epidural analgesia; 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.; Other Names: Epidural analgesia with morphine and ropivacaine
Active Comparator: Balanced general anesthesia and tramadol analgesia; Postoperative period in urology high care unit.	Procedure: General anesthesia; 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.; Drug: Continuous intravenous analgesia; Tramadol 100 mg in the first hour followed by tramadol 300 mg continuously for the next 24 hours.; Other Names: Continuous tramadol infusion

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital of Split
• Investigators: Principal Investigator: Ruben Kovac, University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia; Study Chair: Bozidar Duplancic, University Hospital Center Split, Department of Anesthesiology and Intensive Care, Split, Croatia; Study Chair: Ivan Velat, University Hospital Center Split, Department of Urology, Split, Croatia; Study Chair: Hrvoje Vucemilovic, University Hospital Center Split, Department of Anesthesiology and Intensive Care, Split, Croatia; Study Chair: Svjetlana Dosenovic, University Hospital Center Split, Department of Anesthesiology and Intensive Care, Split, Croatia

Publications and helpful links

General Publications

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
• Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.
• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
• Greg Snow (2020) blockrand: Randomization for Block Random Clinical Trials. R package version 1.5. https://CRAN.R-project.org/package=blockrand
• 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.
• Myles PS. Measuring quality of recovery in perioperative clinical trials. Curr Opin Anaesthesiol. 2018 Aug;31(4):396-401. doi: 10.1097/ACO.0000000000000612.
• 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.
• Kleif J, Gogenur I. Severity classification of the quality of recovery-15 score-An observational study. J Surg Res. 2018 May;225:101-107. doi: 10.1016/j.jss.2017.12.040. Epub 2018 Feb 21.
• Cao X, Yumul R, Elvir Lazo OL, Friedman J, Durra O, Zhang X, White PF. A novel visual facial anxiety scale for assessing preoperative anxiety. PLoS One. 2017 Feb 14;12(2):e0171233. doi: 10.1371/journal.pone.0171233. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Radical prostatectomy; Health related quality of life; General anesthesia; Combined light general and epidural Anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Anesthetics, Local; Anesthetics; Ropivacaine; Morphine; Tramadol
• Other Study ID Numbers: 2181-147-01/06/M.S.-19-2/16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No