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.: PACTR202010665720209 Date of Registration: 01/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound Guided Clavipectoral Block for Postoperative Analgesia of Clavicular Surgery: prospective Randomized Trial
Official scientific title Ultrasound Guided Clavipectoral Block for Clavicular surgery
Brief summary describing the background and objectives of the trial The clavipectoral fascial plane block (CPB) is a novel regional anesthesia technique that has been utilized for clavicular fracture surgeries. Valdés-Vilches originally described the CPB in 2017 as an injection of 10-15 cc of local anesthetic under ultrasound guidance in between the clavipectoral fascia and the periosteum on the medial and lateral aspects of the area of clavicular injury
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: Surgery
Anticipated trial start date 01/10/2020
Actual trial start date
Anticipated date of last follow up 01/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
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
Experimental Group Clavipectorl block A 30 ml total amount of local anesthetic once The patient will be placed in the supine position performed using a high frequency (10-12) MHz linear probe. Ultrasound probe will be placed on the anterior surface of the clavicle on the both medial and lateral side of the fracture. The needle is inserted using in-plane technique. A 30 ml total amount of local anesthetic mixture (1:1 0.5% bupivacaine+2% lidocaine) both medial and lateral side of the fracture equally. 20
Control Group placebo 30 ml normal saline once The patient will be placed in the supine position performed using a high frequency (10-12) MHz linear probe. Ultrasound probe will be placed on the anterior surface of the clavicle on the both medial and lateral side of the fracture. The needle is inserted using in-plane technique. A 30 ml normal saline both medial and lateral side of the fracture equally. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients, of both sexes aged 18-60 years old classified by the American society of anesthesiologists as ASA I and II Patients refusal coagulation disorders chronic analgesic use known allergy to study drugs local site infection neurological deficit on the side of the surgery 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 16/09/2020 Research Ethics Committee of Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El Geish Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome visual analogue scale it will be measured during firrst 24 hours after block
Secondary Outcome Duration of analgesia once within 24 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals El Geish Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Tanta University El Geish Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University El Geish Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dina Ahmed Ali El Malla El Geish Tanta 31527 Egypt
Motaz Amr Abu Sabaa El Geish Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dina EL Malla dr_dina90@yahoo.com 0020403317928 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Motaz Abu Sabaa motaz.abosabaa@med.tanta.edu.eg 0201000029988 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Motaz Abu Sabaa motaz.abosabaa@med.tanta.edu.eg 0201000029988 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care Faculty of Medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1- Demographic data age, sex , weight, height 2- pain score 3- patient satisfaction 4- duration of analgesia Study Protocol 2 years to those who request the data via the email of the principal investigator according to the cause of request
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