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.: PACTR201709002565675 Date of Approval: 28/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pecto-intercostal fascial block vs thoracic paravertebral
Official scientific title Pecto-intercostal fascial block in combination with pectoral nerve block compared to thoracic paravertebral block for the analgesic efficacy in patients undergoing modified radical mastectomy
Brief summary describing the background and objectives of the trial Breast cancer is the most common cancer among women and most of them require breast surgery. [1, 2] Acute postoperative pain is an important risk factor for the development of persistent chronic postoperative pain after breast surgery [3] 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 undesirable side effects may occur. [4] Several forms of regional techniques like local anesthetic infiltration [5], intercostals nerve block [6], and epidural block [7] have been used for management of pain after breast surgery. Thoracic paravertebral block (TPVB) consists in the administration of a local anesthetic solution close to the spinal cord nerve roots after their exit from the intervertebral foramen. [8, 9] TPVB may be considered as an effective option to provide anesthesia and postoperative analgesia during breast surgery. [10] Pectoral nerve (Pecs) block are ultrasound guided interfascial plane block that target tissue planes between the pectoralis major and minor (Pecs I), and the pectoralis minor and serratus anterior muscles (Pecs II). [11, 12] Single injection Pecs block have shown excellent efficacy for analgesia after breast surgery. [13, 14] However, Pecs block do not block the anterior branches of the intercostal nerves or the entire nipple-areolar complex. [15] Pecto-intercostal fascial block (PIFB) targets the anterior cutaneous branch of the intercostal nerve. [16] PIFB may be beneficial for the analgesic management of surgical procedures of the thorax and breast surgery. [17, 18] The aim of the study will be the evaluation and comparison of the analgesic efficacy of the combined PIFB and Pecs block with that of the TPVB in patients undergoing unilateral modified radical mastectomy (MRM).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,postoperative pain,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 01/11/2017
Anticipated date of last follow up 01/04/2018
Actual Last follow-up date 24/09/2018
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
31676/07/17 Tanta University, Faculty of Medicine,Research 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
Control Group TPVB group 15-20 ml of 0.25% bupivacaine once thoracic paravertebral block 30 Active-Treatment of Control Group
Experimental Group PIFB-Pecs group 20 ml of bupivacaine 0.25% between SAM and external intercostal muscle and additional 10 ml between the pectoralis major and minor muscles plus 15 ml of bupivacaine 25% positioned in the interfascial once combined PIFB-Pecs 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
aged 30 ¿ 70 years, ASA I-III, undergoing unilateral MRM body mass index (BMI) > 35 kg/m2, mental disorders, any contraindication to regional anesthesia (e.g. local infection, coagulation abnormality, or patient refusal), known allergy to the study drug, pregnancy, drug or alcohol abuse a 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 postoperative VAS at admission to PACU, 1h, 2h, 4h, 6h, 12h, 18h, 24h postoperatively
Secondary Outcome cumulative morphine consumption morphine titration consumption and 24 h morphine PCA requirements
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 University, Faculty of Medicine 10 Algeish street Tanta 31951 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of anesthesia and surgical ICU 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
Mohamed Mohye Eldin 55 Stad street Tanta 31951 Egypt
Shaimaa Farouk 1 Moheb street Almahalla Alkobra 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 ofanesthesia and ICU
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 31951 Egypt Lecturer ofanesthesia and ICU
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 ofanesthesia and ICU
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