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

NCT04587505 | Completed Phase 4

• 1 other identifier: 2181-147-01/06/M.S.-19-2/16
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Visual analog scale of pain- at rest and during coughing and straining

  24 hours after surgery

• Numerical pain scale - at rest and during coughing and straining

  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

• Numerical anxiety scale

  24 hours after surgery

Study Arms (2)

Epidural anesthesia and analgesia

ACTIVE COMPARATOR

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; Drug: Postoperative epidural analgesia

Balanced general anesthesia and tramadol analgesia

ACTIVE COMPARATOR

Postoperative period in urology high care unit.

Procedure: General anesthesia; Drug: Continuous intravenous analgesia

Interventions

Epidural anesthesia with light general anesthesia PROCEDURE

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.

Epidural anesthesia and analgesia

Postoperative epidural analgesia DRUG

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.

Also known as: Epidural analgesia with morphine and ropivacaine

Epidural anesthesia and analgesia

General anesthesia PROCEDURE

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.

Balanced general anesthesia and tramadol analgesia

Continuous intravenous analgesia DRUG

Tramadol 100 mg in the first hour followed by tramadol 300 mg continuously for the next 24 hours.

Also known as: Continuous tramadol infusion

Balanced general anesthesia and tramadol analgesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective radical Prostatectomy.
• American Society of Anesthesiologists (ASA) physical status classification system: I, II, III

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Split: lead

Study Sites (1)

University Hospital Split

Split, 21000, Croatia

Location

Related Publications (9)

• Greg Snow (2020) blockrand: Randomization for Block Random Clinical Trials. R package version 1.5. https://CRAN.R-project.org/package=blockrand

  BACKGROUND

• 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.

  PMID: 12577163 BACKGROUND

• Myles PS. Measuring quality of recovery in perioperative clinical trials. Curr Opin Anaesthesiol. 2018 Aug;31(4):396-401. doi: 10.1097/ACO.0000000000000612.

  PMID: 29846193 BACKGROUND

• 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.

  PMID: 23471753 BACKGROUND

• 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.

  PMID: 10740540 BACKGROUND

• 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.

  PMID: 23411725 BACKGROUND

• 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.

  PMID: 29397134 BACKGROUND

• 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.

  PMID: 29605019 BACKGROUND

• 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.

  PMID: 28196099 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Agnosia

Interventions

Anesthesia, Epidural; Analgesia, Epidural; Morphine; Ropivacaine; Anesthesia, General

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Analgesia; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ruben Kovac

  University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia

  PRINCIPAL INVESTIGATOR

• Bozidar Duplancic

  University Hospital Center Split, Department of Anesthesiology and Intensive Care, Split, Croatia

  STUDY CHAIR

• Ivo Juginovic

  University Hospital Split, Department of Urology

  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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: April 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

CR (1)