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.: PACTR202008763735746 Date of Approval: 03/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pericapsular Nerve Group (PENG) Block for Hip Fracture; a prospective randomized controlled trial
Official scientific title Pericapsular Nerve Group (PENG) Block for Hip Fracture; a prospective randomized controlled trial
Brief summary describing the background and objectives of the trial Hip fracture is a common orthopedic emergency in the elderly, and it is associated with significant morbidity and mortality.1 Surgical reduction and fixation are the definitive treatment in most patients.2 Effective perioperative analgesia that minimizes the need for opioids and related adverse effects (such as delirium) is essential in this patient population.3,4 Regional analgesic techniques, including femoral nerve (FN) block, fascia iliaca block (FIB), and 3-in-1 FN block, are popular analgesic strategies, due mainly to their opioid-sparing effects and reduction in opioid-related adverse effects.5–7 The effect size of analgesia from these blocks is only moderate,8 and literature suggests that the obturator nerve (ON) is not covered.9,10 The anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as reported by previous anatomic studies.11–13 The anterior capsule is the most richly innervated section of the joint,14 suggesting these nerves should be the main targets for hip analgesia. A recent anatomical study by Short et al 15 confirmed the innervation of the anterior hip by these 3 main nerves, but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported.16 The aim of this study is to evaluate the analgesic efficacy of PENG block in patients undergoing surgery for hip fractures.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied perioperative analgesia for hip fracture surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 24/06/2019
Actual trial start date
Anticipated date of last follow up 24/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
33043 Tanta University Faculty of Medicine Research Ethics Committee
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 control group sham PENG block using 1 ml normal saline single shot sham PENG block 30 Placebo
Experimental Group Pericapsular nerve group block 20 ml bupivacaine 0.25% with epinephrine 1:200000 single shot ultrasound guided PENG block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 18- 70 years either gender ASA I-III elective hip fracture surgery patient refusal patients with any contraindication to regional anesthesia (e.g. local infection, coagulation abnormality) known allergy to local anesthetics mental disorders drug or alcohol abuse Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 01/04/2019 Tanta University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Algeish street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 24 h postoperative rescue analgesic consumption after 24 h postoperatively
Secondary Outcome postoperative VAS score at admission to the PACU, 30min, 1h, 2h ,4h, 6h, 8h, 12, 18, and 24h postoperative
Secondary Outcome time to first analgesic request when occurs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Algeish street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
department of anesthesia and surgical ICU Tanta University Hospital Algeish street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Faculty of Medicine Algeish street Tanta Egypt University
Secondary Sponsor Department of anesthesia and surgical ICU Tanta University Hospital Algeish street Tanta Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mohye Eldin 55 Stad street Tanta Egypt
Shaimaa Farouk 1 Moheb street Almahalla Alkobra Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of anesthesia and surgical ICU Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of anesthesia and surgical ICU Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin mohd_yazed75@yahoo.com 01099707168 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of anesthesia and surgical ICU Faculty of Medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data of the primary outcome Informed Consent Form Data will be available for 6 months after the manuscript is accepted for publication. Data will be accessed through the corresponding author within the specified time frame.
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