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: www.pactr.org
Trial no.: PACTR202012779661309 Date of Approval: 24/12/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title TRANSRECTAL ULTRASOUND GUIDED PROSTATE BIOPSY: PERIPROSTATIC BLOCK VERSUS CAUDAL BLOCK FOR ANALGESIA.
Official scientific title TRANSRECTAL ULTRASOUND GUIDED PROSTATE BIOPSY: PERIPROSTATIC BLOCK VERSUS CAUDAL BLOCK FOR ANALGESIA.
Brief summary describing the background and objectives of the trial Background: Transrectal ultrasound (TRUS) guided prostate biopsy is a potentially painful procedure, due to the insertion of the TRUS probe in the anus and multiple passes of the biopsy needle through the rectum and prostate. Several methods of reducing pain and discomfort have been described. These include intra-rectal local anaesthetic gel (IRLA) instillation, periprostatic nerve block (PPNB), caudal block (CB) and oral analgesics. CB has potential complications of dural puncture and anaesthetic failure, while PPNB may be complicated by intravascular injection with systemic local anaesthetic toxicity. Only a few studies have compared transrectal PPNB with CB with equivocal results. Objectives: This study compared transrectal PPNB to CB in terms of efficacy of analgesia and incidence of complications. Methods: A prospective randomized clinical trial was carried out among 80 consenting patients with an indication for TRUS guided prostate biopsy in the Urology division of University College Hospital, Ibadan. Eighty participants were each randomized to either Group A (CB with 10ml of 2% lidocaine) or Group B (PPNB with a total of 20ml of 1% lidocaine). The pain was assessed using an 11-point numerical rating scale (NRS) and questions on satisfaction with the procedure and willingness for a repeat procedure were asked. The incidence of complications was also recorded.
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 Treatment: Drugs
Anticipated trial start date 07/05/2018
Actual trial start date 07/05/2018
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Caudal Block 10ml of 2% lidocaine 30mins For every patient assigned to the caudal block group, 160 mg of intravenous gentamicin was administered as pre-procedure antibiotic prophylaxis. Thereafter, the patient was positioned prone and the skin of the lower back was prepared with standard skin preparation solution, then 10ml of 2% lidocaine was injected with a 22G needle into the epidural space through the sacral hiatus. Inadvertent injection into a blood vessel was prevented by aspirating prior to injection and repositioning the needle if blood was aspirated into the syringe. The adequacy of the block was then assessed with a perineal needle prick and finding a lax anal sphincter when a rectal examination was done. Occasionally, a mild elongation of the penis was also observed. The patient was then repositioned in the left lateral decubitus position and after a 5- minute wait, the prostate biopsy was commenced. 40 Active-Treatment of Control Group
Experimental Group Periprostatic nerve block 20ml of 1% lidocaine 30mins Each patient was placed in the left lateral position, and following the administration of intravenous antibiotic (gentamicin 160mg) prophylaxis, the transrectal ultrasound probe was inserted into the rectum. Under TRUS guidance, with a 22G 20cm-long spinal needle, 5ml of 1% lidocaine was infiltrated into the neurovascular bundle around the junction of the prostate and seminal vesicles bilaterally and on both sides of the prostatic apex to make a total of 20ml of 1% lidocaine infiltrated. Appropriate and adequate injection was confirmed by observing a hypoechoic wheal on the ultrasound screen as the anaesthetic agent was injected. Inadvertent intravascular injection was prevented by test aspiration prior to infiltration and adjusting the needle if blood was aspirated. After a 5- minute wait, the prostate biopsy was commenced 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting male patients for whom a TRUS guided prostate biopsy was indicated for suspected prostate cancer were included in the study. The indications being elevated serum PSA values with abnormal digital rectal examination (DRE) findings. Patients with obvious spinal metastases with paraplegia, patients with bleeding disorders, acute prostatitis, painful anal conditions, and allergy to local anesthetic 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 100 Year(s) Male
All consenting male patients for whom a TRUS guided prostate biopsy was indicated for suspected prostate cancer were included in the study. The indications being elevated serum PSA values with abnormal digital rectal examination (DRE) findings. Patients with obvious spinal metastases with paraplegia, patients with bleeding disorders, acute prostatitis, painful anal conditions, and allergy to local anesthetic Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 100 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 28/12/2017 University of Ibadan University College Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
College of Medicine University of Ibadan Ibadan 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain perception as measured by a numerical rating scale 0 to10. T1- at administration of caudal block or peri-prostatic block T2- at insertion of TRUS probe T3- at prostate biopsy T4- at thirty minutes after biopsy T5- one day after biopsy
Secondary Outcome Incidence of complications at 72hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Queen Elizabeth Road Ibadan 23401 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Oluwatobi A. Fasola Department of Surgery, University College Hospital, Ibadan. Ibadan 23401 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oluwatobi Fasola Dept of Surgery University College Hospital Ibadan Ibadan 23401 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
No collaborators No collaborators No collaborators Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oluwatobi Fasola fasola.oluwatobi@yahoo.com +2348062109726 Dept of Surgery University College Hospital
City Postal code Country Position/Affiliation
Ibadan 23401 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Oluwatobi Fasola fasola.oluwatobi@yahoo.com +2348062109726 Dept of Surgery University College Hospital
City Postal code Country Position/Affiliation
Ibadan Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Oluwatobi Fasola fasola.oluwatobi@yahoo.com +14373316009 Dept of Surgery University College Hospital
City Postal code Country Position/Affiliation
Ibadan 23401 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results and the study protocol Informed Consent Form,Study Protocol 3 years open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 11/12/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 11/12/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 17/12/2020 Age category added Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 21/12/2020 Omitted actual trial start date 07 May 2018
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 21/12/2020 Omitted at first submission Dr. Oluwatobi A. Fasola , Department of Surgery, University College Hospital, Ibadan., Ibadan, 23401, Nigeria, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 21/12/2020 Omitted section No collaborators, No collaborators, No collaborators, , Nigeria