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.: PACTR202202868568136 Date of Approval: 07/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound guided pericapsular nerve block versus interscalene plexus block for postoperative analgesia after shoulder arthroscopy- A randomized controlled study
Official scientific title Ultrasound guided pericapsular nerve block versus interscalene plexus block for postoperative analgesia after shoulder arthroscopy- A randomized controlled study
Brief summary describing the background and objectives of the trial Shoulder surgery ranks among the most painful surgical interventions. Its postoperative pain intensity is purported to rival that of revision hip and knee arthroplasty as well as thoracotomy.(1,2) Regional anesthesia (RA) is preferred in shoulder surgery as an effective means of providing anesthesia and postoperative analgesia.1Commonly used techniques for shoulder surgery include interscalene brachial plexus (ISB) blocks, suprascapular nerve blocks (SSB), supraclavicular nerve blocks (SCB).(3) Interscalene brachial plexus block (ISB) remains the gold standard for analgesia after shoulder surgery. Unfortunately, the occurrences of ipsilateral phrenic nerve block and hemidiaphragmatic paralysis (HDP) limit its use in patients with preexisting pulmonary compromise.(2,4) Recently, pericapsular Nerve Group (PENG) Block, a new regional technique is used for block of articular branches of the shoulder and well pericapsular spread around the glenohumeral joint.(5) In the present study, we assume that PENG Block may offer a noinferior analgesia and less incidence of nerve block related adverse events compared with ISB. Aim of the study: The primary aim of this study is to assess the postoperative analgesia using VAS score at rest and dynamic. The secondary aim is to assess the duration of analgesia, opioid consumption and nerve block related side effect.
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 Treatment: Drugs
Anticipated trial start date 01/11/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 01/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PNG block 20 cc of 0.5% bupivacaine hydrochloride 20 min The patient’s arm is placed in external rotation andabducted at 45 degrees. A linear ultrasound probe is placed longitudinally between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle over it, a 50-mm needle is inserted using the ‘‘in plane’’ technique. The needle tip is placed between the deltoid muscle and subscapu laris tendon, and 20 cc of 0.5% bupivacaine hydrochloride is injected 50
Control Group Interscalene block 15 ml 0.5% bupivacaine 20 min Following skin and subcutaneous infiltration with 1 ml of 1% lidocaine, a 5- 22 cm gauge insulated needle (B. Braun Medical Inc., USA) was inserted in -plane technique with the probe in a lateral-to-medial needle direction and tip near to C5 and C6 roots into the interscalene grove. The interscalene nerve block injection endpoint was posterior to the brachial plexus at this level. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age:18-60 years old ASA I-III age below 18 years severe pulmonary disease chronic pain disorders, infection at the shoulder region allergy to local anesthetic pregnancy Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 20/01/2022 ethics committee Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
ethics committee Faculty of Medicine Alexandria University Alexandria 21563 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain severity at rest using VAS, time to first rescue analgesic request, overall morphine consumption and patient’s satisfaction in the first postoperative day. during 24 hrs postoperatively
Secondary Outcome hemi diaphragmatic motion on the operated side, pulmonary assessments, Opioid and block related side effects. during 24 hrs postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Hadara University Hospita El Hadra, Alexandria Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rabab saber Saleh Mahrous 33 Bahaa Eldin Elghatwary st. Smouha Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rabab Saber Mahrous 33 Bahaa ElDin st, Smouha Alexandria 21647 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rabab Mahrous roba98@hotmail.com 00201223497339 33 Bahaa Eldin Elghatwary st, Smouha
City Postal code Country Position/Affiliation
Alexandria 21648 Egypt Assistant professor of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries Tarek Ismael drtarek.anesth@gmail.com 00201227392464 Smouha
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Anesthesia Helwan University
Role Name Email Phone Street address
Public Enquiries Ashraf Arafat ashrafarafat67@yahoo.com 00201223497339 smouha
City Postal code Country Position/Affiliation
Alexandria 21648 Egypt Professor of Anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes ill individual participant data be available (including data dictionaries)? Yes - What data in particular will be shared? All of the individual participant data collected during the trial, after deidentification - What other documents will be available? Study Protocol - When will data be available (start and end date) Immediately following publication, for 1 year. - With who? Anyone who wishes to access the data - For what types of analyses? Any purpose - By what mechanism will date be made available Data are available by a link that will be provided after completion. Study Protocol Immediately following publication, for 1 year. open
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