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

Prostatic Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05566405
• Other study ID #: PN 20511/14.10.2020
• Status: Completed
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Sismanoglio General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

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).
• 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%).
• Open Retropubic Radical Prostatectomy
All patients will undergo a nerve-sparing open retropubic radical prostatectomy

Locations

Country	Name	City	State
Greece	Sismanoglio General Hospital	Maroúsi	Attiki

Sponsors (2)

Lead Sponsor	Collaborator
Sismanoglio General Hospital	National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lepor H. A review of surgical techniques for radical prostatectomy. Rev Urol. 2005;7 Suppl 2:S11-7. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Change	Measurement of patients systolic and diastolic blood pressure during the operation and post-operatively for 72 hours.	Peri-operatively
Primary	Heart Rate Change	Measurement of patients Heart Rate during the operation and post-operatively for 72 hours.	Peri-operatively
Primary	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
Primary	Blood Loss During Surgery	Measured from suction contents intra-operatively in ml	Peri-operatively
Primary	Haemoglobin Change	Haemoglobin measurement before the operation and at 12-, 24- and 48-hours post-operatively, in g/dL	Peri-operatively
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Total Hospital Stay	Days until patient discharge from the hospital.	Peri-operative
Secondary	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