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.: PACTR201709002647413 Date of Approval: 18/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pecto-intercostal fascial block vs Pecc block
Official scientific title The analgesic efficacy of Pecto-intercostal fascial block in combination with pectoral nerve block in patients undergoing modified radical mastectomy
Brief summary describing the background and objectives of the trial Breast czancer is the most common cancer among women and most of them require breast surgery. Acute postoperative pain is an important risk factor for the development of persistent chronic postoperative pain after breast surgery. Therefore, effective postoperative pain management after breast cancer surgery is necessary. Systemic opioids can be administered using patient-controlled devices but the analgesic effect can be limited and un-desirable side effects may occur. Several forms of regional techniques like local anesthetic infiltration, intercostal nerve block, epidural block and PVB have been used for management of pain after breast surgery. Pectoral nerve block (Pecs) block is an ultrasound guided inter-fascial plane block that targets tissue planes between the pectoralis major and minor (Pecs I0, and the pectoralis minor and serratus anterior muscles (Pecs II). Single injection Pecs block have shown excellent efficacy for analgesia after breast surgery. However, Pecs block do not block the anterior branches of the intercostal nerves or the entire nipple-areolar complex. Pecto-intercostal fascial block (PIFB) targets the anterior cutaneous branch of the intercostal nerve. PIFB may be beneficial for the analgesic management of surgical procedures of the thorax and breast surgery. The aim of the study will be the evaluation and comparison of the analgesic efficacy of the combines PIFB and Pecs block with that of the Pecs block alone in patients undergoing unilateral modified radical mastectomy (RM)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,postoperative pain after unilateral modified radical mastectomy,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/10/2017
Actual trial start date
Anticipated date of last follow up 01/04/2018
Actual Last follow-up date 27/08/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
31675/07/17 Tanta University, Faculty of Medicine, Tesearch Ethics Committee, Quality Assurance Unit
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 Permuted block randomisation 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 PIFB-Pec group 20ml bupivacaine 0.25% between SAM and external intercostal muscle and another 10ml between pectoralis major and minor and 15ml bupivacain 25% in the interfascial plane between the pectoralis major once combined PIFB-Pecs block 30
Control Group Pecs group 20ml bupivacaine0.25% between SAM and external intercostal muscle and another 10ml between pectoralis mjor and minor once Pecs Block 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
aged between 30 and 70 years; ASA I-III, undergoing unilateral MRM body mass index (BMI > 35kg/m2; Mental disorders; any contraindication to regional anesthesia (eg local infection, coagulation abnormality or patient refusal); known allergy to study drugs; pregnancy; drug or alchol abuse; daily intake of opioid analgesics 30 Year(s) 70 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 01/07/2017 Tanta University Faculty of Medicine Research Ethics Committee Quality Assurance Unit
Ethics Committee Address
Street address City Postal code Country
10 Algeish Street Tanta 31951 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cumulative morphine consuption morphine titration consumption 24hr morphine PCA requirements
Secondary Outcome postoperative VAS admission to PACU, 1hr, 2hr, 4hr, 6hr, 12hr, 18hr, 24hr postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish Street Tanta 31951 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta Univesity, Faculty of Medicine 10 Algeish Street Tanta 31951 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Dept of Anesthesia and Surgical ICU, Tanta University 10 Algeish Street Tanta 31951 Egypt Hospital
Primary Sponsor Tanta University, Faculty of Medicine 10 Algeish Street Tanta 31951 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shaimaa Farouk 10 Moheb Street Almahalla Alkobra 31951 Egypt
Mohamed Mohye 55 Stad Street Tanta 31951 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mohye Eldin Mohd_yazed75@yahoo.com 01120014472 55 Stad Street
City Postal code Country Position/Affiliation
Tanta 31951 Egypt Lecturer of Anesthesia and ICU, Faculty of Medicine, Tanta University
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk Sahimaafarouik7777@yahoo.com 012044771 1 Moheb Street
City Postal code Country Position/Affiliation
Almahalla Alkobra 31951 Egypt Lecturer of Anesthesi and ICU, Faculty of Medicine, Tant University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin Mohd_yazed75@yahoo.com 01120014472 55 Stad Street
City Postal code Country Position/Affiliation
Tanta 31951 Egypt Lecturer of Anesthesia and ICU, Faculty of Medicine, Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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