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.: PACTR202304565008785 Date of Approval: 11/04/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intramuscular Neostigmine for urinary retntion after spinal anesthesia for knee arthroscopy
Official scientific title Intramuscular Neostigmine and Postoperative Urinary Retention After Spinal Anesthesia for knee Arthroscopy, a Prospective Randomized Controlled Study
Brief summary describing the background and objectives of the trial Postoperative urinary retention (POUR) is a disturbing complication that negatively affects patient experience and necessitates interventions, including urinary catheterization, that increase the cost and prolong hospital stay with added risk of urinary tract injury and infection. Generally, the incidence of POUR ranges from 2 to 80 % according to the patient and procedure and anesthetic risk factors. Patient risk factors includes older age, male gender. Long-duration procedures, herniorrhaphy, anorectal surgery, orthopedic surgeries increase the risk for POUR. Also, spinal anesthesia, the perioperative use of opioids, large volume of intravenous fluid, medications that affects urinary bladder tone like anticholinergics, and b antagonists. Arthroscopic knee intervention under spinal anesthesia was associated with higher rate for POUR, 10-84%, especially when long-acting local anesthetics is mixed with intrathecal opioids. which is reported to range from. Since most of knee arthroscopy is performed as a day-case surgery, POUR can be a distressing complication for both the patient and the hospital team. Intervention for prevention of POUR includes early ambulation, neuromodulation, anti-spasmodic agents, non-steroidal anti-inflammatory drugs, and alpha-adrenergic antagonist. Neostigmine, which is one of the most commonly used drugs in anesthesia, was investigated for prevention of POUR. 8-9 Intramuscular injection of neostigmine is believed to increase detrusor muscle activity by increasing acetyl choline concentration and enhancement of parasympathetic activity involved in bladder emptying. This study evaluates the role of Intramuscular neostigmine in the prevention of POUR in patients undergoing knee arthroscopy under spinal anesthesia (primary variable). Secondary variables will include time to voiding, volume of first voided urine, residual bladder volume after first voiding, the need of urinary catheter insertion, time to sensation of full bladder.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/04/2023
Actual trial start date 01/05/2023
Anticipated date of last follow up 15/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group N 0.5 mg Neostigmine intramuscular 6 hours after surgery In group N (n=40), 1 ml syringe containing 0.5 mg neostigmine will be injected in the vastus lateralis muscle after negative aspiration. 40
Control Group C gorup 1 ml normal saline intramuscular 6 hours after surgery in group C (n=40), 1 ml syringe containing normal saline will be injected in the vastus lateralis muscle after negative aspiration. 40 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients undergoing arthroscopic interventions under spinal anesthesia will be recruited for the study. Included patents will be of both gender, age from 18-44years, ASA Physical Status Classification I-II. Patients with diabetes millets, on beta blockers, prostatic hyperplasia, previous pelvic surgery, previous urologic surgery, history of catheterization, urogenital anomalies (incontinence, reflux), renal impairment, neurological disease known allergy to neostigmine Adult: 19 Year-44 Year 18 Year(s) 44 Year(s) Both
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 04/04/2023 Institutional research board Mansoura university
Ethics Committee Address
Street address City Postal code Country
Elgomhoreya Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The overall incidence of postoperative urinary retention in the first postoperative day the incidence will be measured during the first 24 hours after surgery
Secondary Outcome time to voiding 24 hours after surgery
Secondary Outcome residual bladder volume after first voiding 24 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hopsital Elgomhoreya street Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura university Elgomhoareya MAnsoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university Elgomhoreya MAnsoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
Rania Almohammady Elgomhoreya Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Assistant professor Anesthesia department Mansoura University
Role Name Email Phone Street address
Public Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
MAnsoura Egypt Assistant professor Anesthesia department Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Assistant professor Anesthesia department Mansoura University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study protocol, individual patient data files ( not including personal data), statistical analysis plan will be available for sharing 3-6 month after study completion Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol months after completion of the study individuals or authorities covered by a relevant ethical committee
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