The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy

Comparative Study of the Effects of Combined Spinal Anaesthesia and General Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy in Patients With Localised Prostate Cancer

Prostate cancer is one of the most commonly diagnosed neoplasm in men worldwide. The gold standard of therapy is radical prostatectomy, a wide surgical excision of the neoplasm and can be performed either open, laparoscopic or robotic. The open retropubic approach, still performed today, can be completed under either general anaesthesia or combined (spinal/epidural) anaesthesia without any clear guideline on which one should be preferred.

In this study the investigators aim to evaluate general anaesthesia and combined (spinal/ epidural) anaesthesia in patients undergoing open retropubic radical prostatectomy and define whether these may have an impact on the oncological outcome and safety of the procedure.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasm
• Intervention / Treatment: Procedure: General Anaesthesia; Procedure: Open Retropubic Radical Prostatectomy; Procedure: Combined (Epidural and Spinal) Anaesthesia

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Maroúsi, Attiki, Greece, 15126
      • Sismanoglio General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Diagnosed with localised prostate cancer
• Eligible for open retropubic radical prostatectomy

Exclusion Criteria:

• Metastatic prostate cancer
• History of severe heart disease
• History of haemostasis disorders
• History of previous pelvic surgery
• History of lung disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General Anaesthesia; Patients undergoing open retropubic radical prostatectomy under general anaesthesia	Procedure: General Anaesthesia; All patients in the general anaesthesia group will be premedicated with intravenously administered (iv) midazolam (2mg) and fentanyl (100 mcg). Induction will be performed using intravenous propofol (2.5-3mg/kg) and lidocaine (40mg); dexamethasone 8mg, metoclopramide 10mg and omeprazole 40mg will also be administered. After successful tracheal intubation, total intravenous anaesthesia will be maintained by administering propofol (0.05 mg/kg/sec iv) and remifentanil (0.2 mcg/kg/sec iv). Pain management will be achieved by paracetamol (1g iv) and tramadol (100mg iv) whereas muscle relaxation by vecuronium (0.6 mg/kg iv).; Procedure: Open Retropubic Radical Prostatectomy; All patients will undergo a nerve-sparing open retropubic radical prostatectomy
Active Comparator: Combined (Epidural and Spinal) Anaesthesia; Patients undergoing open retropubic radical prostatectomy under combined (epidural and spinal) anaesthesia	Procedure: Open Retropubic Radical Prostatectomy; All patients will undergo a nerve-sparing open retropubic radical prostatectomy; Procedure: Combined (Epidural and Spinal) Anaesthesia; Combined (epidural and spinal) anaesthesia will be performed using an epidural 18G needle and a spinal 27G needle, in the L2-L3 or L3-L4 interspace. Induction will be carried out by spinal intrathecal administration of levobupivacaine (2.6-3ml of 0.5%) and mild sedation by midazolam (5mg iv in bolus). All patients will be administered dexamethasone 8mg, metoclopramide 10mg and omeprazole 40mg iv. Maintenance will be performed 75 minutes after induction and obtained using an epidural administration of levobupivacaine (4-5ml of 0.5%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Change	Measurement of patients systolic and diastolic blood pressure during the operation and post-operatively for 72 hours.	Peri-operatively
Heart Rate Change	Measurement of patients Heart Rate during the operation and post-operatively for 72 hours.	Peri-operatively
Surgical APGAR Score	Calculation of the Surgical APGAR score for each patient during surgery. The lower the score, on a scale of 1-10, the worst the prognosis of the patient. SAS is calculated using three variables: Estimated blood loss (on a 0-3 scale, 0 points >1000 ml, 1 point 601-1000ml, 2 points 101-600 ml, 3 points <100ml); Lowest mean arterial pressure (on a 0-3 scale, 0 points <40 mmHg, 1 point 40-54 mmHg, 2 points 55-69 mmHg, 3 points >70 mmHg); Lowest heart rate (on a 0-4 scale, 0 points >85 bpm, 1 points 76-85 bpm, 2 points 66-75 bmp, 3 points 56-65 bmp, 4 points <55 bmp) during surgery.	Peri-operatively
Blood Loss During Surgery	Measured from suction contents intra-operatively in ml	Peri-operatively
Haemoglobin Change	Haemoglobin measurement before the operation and at 12-, 24- and 48-hours post-operatively, in g/dL	Peri-operatively
Operation Time	Time required for: Induction of anaesthesia; Completion of the operation; Post-operative time until the patient is successfully transferred to the recovery room	Peri-operatively
Pain Assessed by the VAS Scale	Measured using a pain Visual Analogue Scale (VAS) at 6-, 24- and 48-hours after the operation. VAS is a self-reporting pain scale based on a 0 to 10-point system, with each point measuring 10mm on a linear line. Every patient was asked to indicate his pain levels from "No Pain" (equals 0) to "Worst Pain Imaginable" (equals 10).	Peri-operatively
Complication Rate	Complications related to the procedure: Intraoperative bleeding; Post-operative bleeding; Bowel perforation; Cardiovascular; Respiratory Complications related to the anaesthesia technique performed: Post-operative headache; Nausea and vomiting; Any signs of potential nerve damage (manifested as inability to gain leg motility)	Peri-operatively and up to 1 year after the operation
Change From Baseline PSA Levels at 6-months	Measurement of Prostatic Specific Antigen (PSA) levels at 6 to establish a PSA nadir value	6 months post-operative
Change from 6-month PSA Levels at 12-months	Measurement of Prostatic Specific Antigen (PSA) levels at 12 post-operation to detect any biochemical recurrence	12 months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Erectile Function after Radical Prostatectomy	Measured using the International Index of Erectile Function (IIEF-5) questionnaires pre-operatively and at 3-, 6- and 12-months post-surgery. The test is composed of 5 questions with 5 points for each question. Patients are evaluated accordingly: Score 22 or more = No Erectile Disfunction; Score 17-21 = Mild Erectile Disfunction; Score 12-16 = Mild to moderate Erectile Disfunction; Score 8-11 = Moderate Erectile Disfunction; Score 7 or less = Severe Erectile Disfunction Results will be: Analysed and compared to evaluate any potential difference of the two methods of anaesthesia, on post-operational erectile function; Analysed comparing pre-operation with post-operation questioners overall, to evaluate erectile disfunction after radical prostatectomy regardless of method of anaesthesia.	Up to 1 year after the operation
Post-operative Urinary Incontinence	Measured using the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form at 12 months post-surgery. The Questionnaire is consisted of 4 questions: Frequency "How often do you leak urine?" on a scale of 0 (never) to 5 (all the time); Amount of leakage "How much urine do you leak?" on a scale to 0 (none) to 3 (a large amount); Overall impact on quality of life "How much does it interfere with your life?" on a scale of 0 (not at all) to 10 (a great deal); Timing of leakage "When does urine leak?"	1 year after the operation
Total Hospital Stay	Days until patient discharge from the hospital.	Peri-operative
Patient Satisfaction Assessed by the Short Assessment of Patient Satisfaction (SAPS) Questionnaire	Satisfaction, using the Short Assessment of Patient Satisfaction (SAPS) Questionnaire, is measured in a scale of 0 to 28, with 0 to 10 equals to "Very Dissatisfied", 11-18 equals to "Dissatisfied", 19-26 equals to "Satisfied" and 27-28 equals to "Very Satisfied"	Peri-operative

Collaborators and Investigators

• Sponsor: Sismanoglio General Hospital
• Collaborators: National and Kapodistrian University of Athens
• Investigators: Principal Investigator: Konstantinos Pikramenos, MD, 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens; Study Director: Iraklis Mitsogiannis, Assoc. Prof., 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens; Study Chair: Ioannis Varkarakis, Prof., 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens; Study Chair: Athanasios Papatsoris, Prof., 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens

Publications and helpful links

General Publications

• Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.
• Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
• Hatzinger M, Hubmann R, Moll F, Sohn M. [The history of prostate cancer from the beginning to DaVinci]. Aktuelle Urol. 2012 Jul;43(4):228-30. German.
• Lepor H. A review of surgical techniques for radical prostatectomy. Rev Urol. 2005;7 Suppl 2:S11-7.
• Gawande AA, Kwaan MR, Regenbogen SE, Lipsitz SA, Zinner MJ. An Apgar score for surgery. J Am Coll Surg. 2007 Feb;204(2):201-8. Epub 2006 Dec 27.
• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
• Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683. Review.
• Hawthorne G, Sansoni J, Hayes L, Marosszeky N, Sansoni E. Measuring patient satisfaction with health care treatment using the Short Assessment of Patient Satisfaction measure delivered superior and robust satisfaction estimates. J Clin Epidemiol. 2014 May;67(5):527-37. doi: 10.1016/j.jclinepi.2013.12.010.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: October 1, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 1, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: PN 20511/14.10.2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: On reasonable request after completion of study and analysis.
• IPD Sharing Access Criteria: Any medical researcher on an official capacity will be eligible to submit a request to the primary investigator of the study. Requests will be considered in due time and relevant information released accordingly.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

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