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.: PACTR202002906402947 Date of Approval: 25/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PENG for perioperative analgesia in hip fracture surgery
Official scientific title Continuous pericapsular nerve group block for perioperative analgesia in hip fracture surgery, a prospective randomized study
Brief summary describing the background and objectives of the trial Hip fracture is the most common type of fracture in the elderly population. Regional anesthesia has been preferred by anesthesiologists due to better analgesic profile lower incidence of complications like delirium, and thromboembolic events, added to the simplicity of the technique. (Atallah & Abdel Dayem, 2015; Kowark, Rossaint, & Coburn, 2019). However severe pain is encountered during positioning for spinal anesthesia. Different regional block was utilized to facilitate patient positioning for spinal anesthesia including femoral nerve block, fascia iliaca block and lateral cutaneous nerve block. Pericapsular nerve group (PENG) block was described recently by Girón-Arango et al. for postoperative analgesia in orthopedic surgery. This block is a new regional anesthesia technique based on blocking the femoral nerve (FN) and accessory obturator nerve (ON) with a single injection. In this study, A PENG block will be initiated before patient transfer to operating theater for spinal anesthesia and afterwards, infusion of local anesthesia through the catheter in the pericapsular space for 24 hours offering the patient a pain free experience through the perioperative period. The study group will be compared to the control group; the primary outcome will be the analgesic requirements during the first postoperative day. Secondary outcomes will include perioperative pain scores, surgery feasibility and duration of sensory block, patient satisfaction and perioperative complications including quadratus muscle weakness, nausea, vomiting, shivering, and delirium.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/03/2020
Actual trial start date
Anticipated date of last follow up 01/05/2020
Actual Last follow-up date 30/06/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 50
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PENG group during surgery and the firs postoperative 24 hours. Patients will be given PENG block and catheter fixed in place 30 minutes before spinal anesthesia 30
Control Group Control group During surgery and the first postoperative day Patient will be transferred to operating room and given spinal anesthesia as local 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients scheduled for hip surgery Patients with contraindication to spinal anesthesia (thrombocytopenia (less than 100), INR more than 1.5, valvular stenotic lesions), refusing enrollment, and difficulty to express pain scores will be excluded from the study. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
patients scheduled for hip surgery Patients with contraindication to spinal anesthesia ( thrombocytopenia (less than 100), INR more than 1.5, valvular stenotic lesions), refusing enrollment, and difficulty to express pain scores will be excluded from the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
Hip surgery patients. 1- Thrombocytopenia. 2- INR more than 1. 3- Valvular stenotic lesions). 4- Refusing enrollment. 5- Difficulty to express pain scores. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 02/02/2020 Institutional review board
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 Morphine consumption in milligrams the first postoperative day
Secondary Outcome perioperative pain scores the first postoperative day
Secondary Outcome Duration of sensory block the first postoperative day.
Secondary Outcome quadratus muscle weakness The first postoperative day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university Elfomhoreya Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University Elgomhoreya 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
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alreafey Alreafey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Alrefaey Alreafey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Alreafey alrefaey refa3ey2@yahioo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study protocol, results tables will be available 6 months after completion of the study Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months after completion of the study Data will be available upon request by researchers or organizations covered by an independent 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