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.: PACTR202009919065834 Date of Approval: 21/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A comparative study to assess the analgesic effect of bupivacaine and bupivacaine plus dexmedetomidine in pecs II block in breast surgery
Official scientific title A comparative study to assess the analgesic effect of bupivacaine and bupivacaine plus dexmedetomidine in pecs II block in breast surgery
Brief summary describing the background and objectives of the trial Dexmedetomidine as an adjunct to bupivacaine helps increase the duration and improves the quality of postoperative analgesia in pecs II block without serious side effects.
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 Education /Training
Anticipated trial start date 02/04/2020
Actual trial start date 01/06/2020
Anticipated date of last follow up 01/09/2020
Actual Last follow-up date 15/09/2020
Anticipated target sample size (number of participants) 130
Actual target sample size (number of participants) 105
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Benha university
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 Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group C received 25ml of 0.2 ml/kg of 0.25% of plain bupivacaine were used for modified PEC’s block. One hour before surgery Modified PEC's two-block was performed under ultrasound guidance using SonoSite M Turbo (SonoSite, USA) with linear multifrequency 6–13 MHz transducer (L25 × 13–6 MHz linear array) scanning probe. Under complete aseptic condition and with the patient in the supine position with the arm abducted 90o. The probe was applied at the med clavicular level and angled inferolateral. The pectoralis muscle was identified with the axillary artery and vein on sonography. The brachial plexus should be visible underneath. 10 ml of the test solution was injected between the pectoralis major and minor. Then the probe was turned laterally to identify the pectoralis minor and serratus anterior muscles then 15 ml of test solution was injected. 54 Active-Treatment of Control Group
Experimental Group Group Dex received 25 ml of 0.2 ml/kg of 0.25% of plain bupivacaine plus dexmedetomidine one hour before surgery Modified PEC's two-block was performed under ultrasound guidance using SonoSite M Turbo (SonoSite, USA) with linear multifrequency 6–13 MHz transducer (L25 × 13–6 MHz linear array) scanning probe. Under complete aseptic condition and with the patient in the supine position with the arm abducted 90o. The probe was applied at the med clavicular level and angled inferolateral. The pectoralis muscle was identified with the axillary artery and vein on sonography. The brachial plexus should be visible underneath. 10 ml of the test solution was injected between the pectoralis major and minor. Then the probe was turned laterally to identify the pectoralis minor and serratus anterior muscles then 15 ml of test solution was injected. 51
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Their ages ranged between 18: 50 years old and Class I and II ASA physical status. scheduled for breast conservative surgery. Patients with coagulation disorders, hepatic or renal impairment, previous chest surgery, uncooperative patients, skin infection at the puncture site , patient with a history of allergy to any of the study drugs Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Female
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 07/06/2020 A comparative study to assess the analgesic effect of bupivacaine and bupivacaine plus dexmedetomidine in pecs II block in breast surgery.
Ethics Committee Address
Street address City Postal code Country
Farid nada st.Benha Benha 13511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome early onset of sensory block ,pronged time of first analgesic requirement, decrease dose of total morphine consumption 5 times
Secondary Outcome The onset of sensory block was significantly earlier in group Dex compared with group C. Time to first analgesic request was prolonged considerably in group Dex compared with group C. Total morphine consumption, and the number of patients requiring analgesia was significantly lower in group Dex in comparison with group C. 5 times
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha university hospital Farid nada st.Benha Benha 13511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
enas wageh mahdy 47 Elmotasem sr Benha Benha 13512 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Benha university hospital Farid nada se,Benha Benha 13511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
anesthesia and general surgery collaborator Farid nada sr.Benha Benha 13511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ENAS MAHDY ewm01221592827@gmail.com 00201029286117 47 EL-moetasem st
City Postal code Country Position/Affiliation
Benha 13511 Egypt leccture of anesthsia
Role Name Email Phone Street address
Principal Investigator AHMED ABD ELREHMAN ahmed76hamdy@yahoo.com 00201004337483 Mit Asem-Benha Qlluobia
City Postal code Country Position/Affiliation
Benha 13814 Egypt leccture of anesthsia
Role Name Email Phone Street address
Scientific Enquiries AHMED Abd ELHamid bashaahmed@yahoo.com 00201005204130 20 Ezz ELdin omar st.ELharam
City Postal code Country Position/Affiliation
Giza 12111 Egypt professor
Role Name Email Phone Street address
Public Enquiries Saad Saad saaddibrahim-7@yahoo.com 00201223142889 Oman st.Elmohandseen,Giza
City Postal code Country Position/Affiliation
Giza 12111 Egypt professor of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after de identification (text, tables, figures, other documents will be available like study protocol.the data will be available immediately following publication 2 monthes it is open request type,type of data analysis is predictive.proposal should be directed to enaswageh@yahoo.com to gain access.data requestors will need to sign to data accessagreement.data will be available for at least 5 years at third party websit(www.bu.edu.eg)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.bu.edu.eg Yes 21/08/2020
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