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AnesthesiaPhase 4QoRNCT04587505

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

A Phase 4 study testing Epidural anesthesia with light general anesthesia, Postoperative epidural analgesia and General anesthesia in people with Anesthesia and Anesthesia Recovery Period, run by University Hospital of Split at 1 site in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
What is being tested?
Epidural anesthesia with light general anesthesia, Postoperative epidural analgesia and General anesthesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteCroatia
Study dates
1 Apr 2019to 1 Jun 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Dementia
  • Delirium
  • Acute psychosis
  • Emergent surgery
  • Hospitalisation in Intensive care unit
  • American Society of Anesthesiologists (ASA) physical status classification system: IV
Show all 10Show fewer
  • Reoperations
  • Muscular diseases
  • Montreal cognitive test <24 points
  • Contraindications for epidural anesthesia

Trial locations and contacts

1 site in 1 country.

Croatia1 site

  • University Hospital Split

    Split, 21000

Other trials in Croatia

About this study

Official title: 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.

Read the 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.

Being tested
Epidural anesthesia with light general anesthesia, Postoperative epidural analgesia, General anesthesia, Continuous intravenous analgesia
Keywords
General anesthesia, Combined light general and epidural Anesthesia, Health related quality of life, Radical prostatectomy
Medical subject headings
Patient Satisfaction, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidural anesthesia with light general anesthesiaProcedure or surgery

    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.

  • Postoperative epidural analgesiaDrug

    Also called Epidural analgesia with morphine and ropivacaine

    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.

  • General anesthesiaProcedure or surgery

    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.

  • Continuous intravenous analgesiaDrug

    Also called Continuous tramadol infusion

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

Study groups in NCT04587505
Study groupRoleWhat they receive
Epidural anesthesia and analgesiaActive comparatorEpidural 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).
Receives: Procedure: Epidural anesthesia with light general anesthesia; Drug: Postoperative epidural analgesia
Balanced general anesthesia and tramadol analgesiaActive comparatorPostoperative period in urology high care unit.
Receives: Procedure: General anesthesia; Drug: Continuous intravenous analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 hours after surgery

  2. 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.

    Measured: 24 hours after surgery

  3. 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.

    Measured: 24 hours after surgery

Secondary outcomes (9)

  1. 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 ).

    Measured: 24 hours after surgery

  2. 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 ).

    Measured: 24 hours after surgery

  3. 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 ).

    Measured: 24 hours after surgery

  4. 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.

    Measured: 24 hours after surgery

  5. 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.

    Measured: 24 hours after surgery

  6. 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.

    Measured: 24 hours after surgery

  7. 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).

    Measured: 24 hours after surgery and one month after surgery]

  8. 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.

    Measured: 24 hours after surgery

  9. 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.

    Measured: 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start1 Apr 2019
  3. Primary completion1 Apr 2021
  4. Study completion1 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04587505
Sponsor's protocol ID
2181-147-01/06/M.S.-19-2/16
Acronym
QoR
Status last verified
Sep 2021
First submitted
7 Oct 2020
Last updated
30 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 12577163

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

    PubMed 29846193

  • 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.

    PubMed 23471753

  • 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.

    PubMed 10740540

  • 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.

    PubMed 23411725

  • 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.

    PubMed 29397134

  • 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.

    PubMed 29605019

  • 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.

    PubMed 28196099

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Epidural anesthesia with light general anesthesia, Postoperative epidural analgesia and General anesthesia in people with Anesthesia and Anesthesia Recovery Period, run by University Hospital of Split at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analog scale of quality of recovery (QoR) (time frame: 24 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04587505, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.

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