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.: PACTR202109797374925 Date of Approval: 23/09/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative Study between Femoral Nerve Block and Saphenous Nerve Block in Enhanced Recovery after Knee Replacement Surgery under Spinal Anesthesia
Official scientific title A Comparative Study between Femoral Nerve Block and Saphenous Nerve Block in Enhanced Recovery after Knee Replacement Surgery under Spinal Anesthesia
Brief summary describing the background and objectives of the trial Aim of this study is to investigate the effect of femoral nerve block using 0.25% bupivacaine versus saphenous nerve block using 0.5% bupivacaine in enhanced recovery after knee replacement surgery under spinal anesthesia.
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: Other
Anticipated trial start date 11/08/2019
Actual trial start date 18/08/2019
Anticipated date of last follow up 16/01/2020
Actual Last follow-up date 30/07/2020
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants) 60
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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group F Patients received 20 ml of 0.5% bupivacaine perineural around femoral nerve 15 minutes Patients received ultrasound guided femoral nerve block with 20 ml of 0.5% bupivacaine at the end of the surgical procedure 30 Active-Treatment of Control Group
Experimental Group Group S Patients received 20ml of 0.5% bupivacaine perineural around saphenous nerve given immediately at the end of surgical procedure Patients received ultrasound guided saphenous nerve block with 20 ml of 0.5% bupivacaine at the end of the surgical procedure 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients of American Society of Anesthesiologists (ASA) physical status I to II of both genders aged 21-75 years scheduled for elective knee replacement surgeries under spinal anesthesia Patients with clinically significant coagulopathy Infection at the injection site Allergy to local anesthetics Polytrauma patients having lower limb fractures Patients with pre-existing myopathy or neuropathy on the operating limb Patients with significant cognitive dysfunction Chronic analgesic abuser patients Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 75 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 04/08/2019 Ain Shams University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Rmases street , Abbasia Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to compare the quadriceps muscle power between the two groups, by asking the patient to raise his leg while fixation of the thigh by the examiner and also by a Timed Up-and-Go test (TUG test) during 24 hours postoperative. 30 min after admission to PACU, 2,6 12, 24 hours postoperatively
Secondary Outcome Postoperative analgesic efficacy in terms of pain scores using Numerical Rating Scale (NRS) 30 min after admission to PACU, 2,6 12, 24 hours postoperatively
Secondary Outcome total Nalbuphine consumption, as a rescue analgesic drug 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams university hospitals Ramses street , Abbasia Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Aya Mahmoud Elghandour West Somid-Neighborhood 13-Block 11-Lotus street-Villa No.3 6th of october Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aya Mahmoud Elghandour West Somid-Neighborhood 13-Block 11-Lotus street-Villa No.3 6th of october Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Aya Hisham Moussa Ahmad Ramses street , Abbasia Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aya Elghandour ayael4andour@gmail.com 00201060375714 West Somid-Neighborhood 13-Block 11-Lotus street-Villa No.3
City Postal code Country Position/Affiliation
6th of october Egypt Assistant lecturer of anesthesia at Ain Shams university hospitals
Role Name Email Phone Street address
Public Enquiries Aya Elghandour ayael4andour@gmail.com 00201060375714 West Somid-Neighborhood 13-Block 11-Lotus street-Villa No.3
City Postal code Country Position/Affiliation
6th of october Egypt Assistant lecturer of anesthesia at Ain Shams university hospitals
Role Name Email Phone Street address
Scientific Enquiries Fathy Tash Viced.research@med.asu.edu.eg 0020226857539 Ramses street, Abbasia
City Postal code Country Position/Affiliation
Cairo Egypt Professor of internal medicine at Ain Shams university hospitals
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All participants data was presented in an Excel sheet and it is available with the corresponding author "ayael4andour@gmail.com" Statistical Analysis Plan 12 months Editors of journal to be submitted to
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available 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