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

Quality of Life Clinical Trial

— QoR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587505
• Other study ID #: 2181-147-01/06/M.S.-19-2/16
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2021
• Source: University Hospital of Split
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Anesthesia
• Anesthesia Recovery Period
• Epidural
• Patient Satisfaction
• Postoperative Period
• Quality of Life
• Quality of Recovery
• Radical Prostatectomy

Intervention

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.

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.

Locations

Country	Name	City	State
Croatia	University Hospital Split	Split

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Split

Country where clinical trial is conducted

Croatia, 

References & Publications (9)

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. — View 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. Review. — View Citation

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

Kleif J, Gögenur 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. — View Citation

Kleif J, Waage J, Christensen KB, Gögenur 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. — View Citation

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. — View 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. Review. — View Citation

Stamer UM, Höthker F, Lehnen K, Stüber F. [Postoperative analgesia with tramadol and metamizol. Continual infusion versus patient controlled analgesia]. Anaesthesist. 2003 Jan;52(1):33-41. German. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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]
Secondary	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
Secondary	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