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.: PACTR201608001613798 Date of Approval: 03/05/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound guided pudendal nerve block versus conventional technique for elective perineal surgeries
Official scientific title Ultrasound guided bilateral transperineal pudendal nerve block versus conventional technique for elective perineal surgeries: a prospective randomized clinical trial.
Brief summary describing the background and objectives of the trial perineum is a very sensitive organ and perineal surgeries can causes sever pain with prolonged post-operative recovery. Pudendal nerve block has been evaluated in many surgeries to decrease post-operative analgesia over other methods of analgesia with reduced hospital stay. However the conventional technique dose not provide contestant results. The use of ultrasound allows the visualization of different anatomical structures resulting into better outcome and fewer complications, but this technique is new and needs to be evaluated. This study is designed to evaluate and compare the ultrasound guided bilateral transperineal pudendal nerve block with the conventional technique as adjuvant to general anesthesia for patients scheduled for elective perineal surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Peri operative analgesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 16/05/2016
Actual trial start date 16/06/2016
Anticipated date of last follow up 16/05/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants) 68
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
30834/03/16 Research ethics committiee faculty of medicine tanta university
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Nerve stimulator pudendal nerve block once Intra-operative before surgical incision 34 Active-Treatment of Control Group
Experimental Group Ultrsound guided pudendal nerve block once Intra-operative before surgical incision 34
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age: 18-60 ASA I and II elective perineal surgeries -Patient¿s refusal. -Cerebrovascular disease. -History of opioid consumption or drug abuse. -Infection or skin disease at the site of procedure. -Coagulopathy (INR >1.5, platelets < 100.000). -Surgeries < 30 min or >120 min 18 Year(s) 60 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 16/03/2016 research ethics committe faculty of medicine tanta university
Ethics Committee Address
Street address City Postal code Country
El Gaish street tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Success of the technique -pre-induction -post-induction -skin incision -2, 4, 8, 12, 18 hours after recovery
Secondary Outcome Postoperative pain -2, 4, 8, 12, 18 hours after recovery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospitals El-Gaish street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine Tanta University El-Gaish street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anesthesia department Faculty of medicine tanta university El-Gaish street Tanta 31527 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Aliaa Mohammed Belal El-Melegy 9th abdelgaleel Tanta 3125 Egypt
Abdelraheem Mostafa Dowidar 10 saeid Tanta 3125 Egypt
Hoda Al said Ahmed Ezz 3 elgiesh Tanta 3125 Egypt
Rehab Said El kalla 2 elgiesh Tanta 3125 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aliaa El-Melegy aliaa.islam@yahoo.com 0201068936038 Abd-Elgaleel
City Postal code Country Position/Affiliation
tanta 31528 Egypt Assistant lecturer of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Rehab Elkalla Rehouba10@hotmail.com 01285700765 2 giesh street
City Postal code Country Position/Affiliation
Tanta 3125 Egypt Lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries Hoda Ezz Hodaezz714@yahoo.com 01222768250 3 giesh street
City Postal code Country Position/Affiliation
Tanta 3125 Egypt Assistant professor of anesthesia and intensive care
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information