Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202212562960206 Date of Approval: 22/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Different Anaesthetic Modalities for Transurethral Prostatic Stent Fixation in High risk patients
Official scientific title Different Anaesthetic Modalities for Transurethral Prostatic Stent Fixation in High risk patients
Brief summary describing the background and objectives of the trial symptomatic benign prostatic hyperplasia is more common in elderly (26% of men in their sixth decade, 41% in the seventh, and 46% in the eighth and beyond). With success rates of 85–90%, transurethral resection of the prostate is still the gold standard for treating symptoms of the bladder outflow obstruction. Prostatic stents have recently become an alternative, particularly for older, weak patients and those with various medical issues. Only local anaesthetic gel was used during the stent insertion procedure, which could be associated with high levels of psychological stress, severe intra- and postoperative pain, and postoperative discomfort. Therefore, it is critical to select an anaesthetic strategy suitable with such a high likelihood of hemodynamic instability. Therefore, we compared the effectiveness of two anaesthetic techniques, the low dose spinal anaesthesia versus peri-prostatic nerve block, for reducing pain during the insertion of prostatic stents, particularly for elderly and frail patients with multiple medical conditions (ASA III and IV).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Anaesthetic techniques
Anticipated trial start date 01/01/2020
Actual trial start date 01/01/2020
Anticipated date of last follow up 15/11/2020
Actual Last follow-up date 05/11/2020
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Peri prostatic nerve block Before the surgical procedure Each patient underwent a left lateral examination. 10 mL of lidocaine gel (Ultracaine) was applied intrarectally. TRUS (SIEMENS, Acuson X-300) was done five minutes later with a biplane curved trans-rectal probe that was set to the sagittal plane. Under ultrasound guidance, a 22-gauge, 7-inch spinal needle was inserted into the region where the prostatic innervations enter the gland. The probe was oriented laterally until the seminal vesicle-prostate notch could be seen. The fat in this notch, present in all patients and has the appearance of a white pyramid, is what is known as the "Mount Everest sign." Lidocaine hydrochloride 2% was injected in 5 cc increments on each side. The injectate's reaction to the needle's insertion verified its success when an ultrasonic wheal, a separation of the seminal vesicles and prostate from the rectal wall. 27 Active-Treatment of Control Group
Experimental Group Low dose spinal anesthesia Before the surgical procedure The patient was sat with their legs dangling over the end of the table and their spine arched backward. The highest point of the iliac crest was located (Tuffier's line) typically falls between the fourth and fifth lumbar vertebrae). An antiseptic was applied to the patient's back, beginning at the injection site and working outward (This is done three times). A 20 mg/ml dose of lidocaine, a local anaesthetic, was administered. A 23G spinal needle was gradually inserted into the area between L3 and L4's intervertebral discs until CSF was visible returning to the needle's hub. Administration of 1.5 ml of 0.5% hyperbaric bupivacaine was drawn in a 3 ml syringe with 25 mg of fentanyl (0.5 ml). After the injection, the patient had to stay sitting for 5 minutes so that the bupivacaine could sink down and block the saddle area. 27
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Men above the age of fifty scheduled for prostatic stent insertion due to BPH. Approving to participate in the study. ASA III & IV Coagulopathy (INR> 1.5 and platelets <100,000). Allergy to local anesthetics. Patient's refusal. Patients who cannot comply with VAS assessment. 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 82 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/11/2019 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain assessment using visual analogue scale At 5 - 10 - 15 - 20 - 30 - 40 - 50 - 60 minutes
Secondary Outcome Heart rate and mean arterial blood pressure Baseline then at 5 - 10 - 15 - 20 - 30 - 40 - 50 - 60 minutes
Secondary Outcome Satisfaction of the patients and surgeons Immediately postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospitals Kasr A Ainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Victor Farouk Jaccoub Kasr Alainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospitals Kasr Alainy Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Victor Jaccoub victor.jaccoub44@gmail.com +201274488860 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Victor Jaccoub victor.jaccoub44@gmail.com +201274488860 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University Egypt
Role Name Email Phone Street address
Scientific Enquiries Victor Jaccoub victor.jaccoub44@gmail.com +201274488860 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 36 months following article publication. Study Protocol From 12 to 36 months after article publication Data will be accessible on reasonable request through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information