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.: PACTR201810468702376 Date of Approval: 09/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative study between pectoral nerve block and thoracic para vertebral block for postoperative analgesia after breast surgery
Official scientific title Comparative study between pectoral nerve block and thoracic para vertebral block for postoperative analgesia after breast surgery
Brief summary describing the background and objectives of the trial Pectoral nerve (PECs) block is a recently introduced technique for providing surgical anesthesia and postoperative analgesia during breast surgery. The present study was planned to compare the efficacy and safety of ultrasound guided PECs block with thoracic para vertebral block (TPVB) for postoperative analgesia after breast surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/10/2018
Actual trial start date 07/10/2018
Anticipated date of last follow up 07/03/2019
Actual Last follow-up date 07/03/2019
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Not yet 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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A patients will receive a TPVB with bupivacaine 0.5 % throughout the whole procedure Considering the comfort of patients and the ability of local anesthetic to spread to contiguous segments, we adopted multilevel injection at the T2, T4, and T6 levels under ultrasound guidance guidance, the wedge- shaped para vertebral space will be located using a high frequency probe placed lateral to the spinous process at the level of interest. A 22 gauge, 3.5- in spinal needle will be inserted and 8 ml of 0.5% bupivacaine was injected after negative aspiration of blood, air or cerebrospinal fluid at the T2, T4 and T6 level. 40
Experimental Group Group B patients will receive a PECs block with bupivacaine 0.5% before induction of anesthesia throughtout the whole procedure in group B (PECs) blocks targeting the pectoral region. We place the linear probe parallel to the clavicle and medial to coracoid process and visualized the pectoralis minor and major muscles, axillary artery and vein. By pivoting the medial side of the probe we identified the thoracoacromial artery at its origin from the axillary artery, with the needle in-plane from medial to lateral direction, we will inject 3 ml of 0.5% bupivacaine after aspiration of blood in the medial border of pectoralis minor muscle the redirection of probe and inject 7 ml of 0.5% bupivacaine between the lateral border of pectoralis minor and serratus anterior at the third rib level. 40
Control Group Group C throughout the procedure patient will receive general anesthesia only 40 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
the American society of Anesthesiologists (ASA) Physical Status classification, I-III, age 20- 70 years, body mass index (BMI) less than 35 kg/m2 and the female sex. patient with commodities, bleeding disorders, coagulapathy and morbid obese Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 04/10/2018 Faculty of medicine Aswan university
Ethics Committee Address
Street address City Postal code Country
El seel street Aswan EGYPT Aswan 331111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain after the procedure finished
Secondary Outcome hemodynamic effects (blood pressure &heart rate) before and after the procedure ,the duration of analgesia, the need for postoperative analgesia ,the time of starting pain postoperatively and frequency of analgesia required, patient satisfactions to pain management, and the complication related to anesthetic techniques. throughtout the whole procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Aswan university El seel street Aswan 331111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
sherif kamal arafa Gharbia - tanta- 12 tout angh amoun Egypt 331111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sherif kamal arafa Tanta Gharbia Egypt Tanta 333257 Egypt Individual
Secondary Sponsor ayman el mohamedy soliman street Banha 333257 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Sherif kamal Arafa Egypt Gharbia tanta 12 tout angh street Gharbia 333257 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Arafa sherifarafa1020@gmail.com 00201227744329 Egypt / Gharbia / Tanta 12 tout angh amoun street
City Postal code Country Position/Affiliation
Tanta 333257 Egypt lecturer of anesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Sherif Arafa sherifarafa1020@gmail.com 00201227744329 Egypt / Gharbia / Tanta 12 tout angh amoun street
City Postal code Country Position/Affiliation
Tanta 333257 Egypt lecturer of anesthesia and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries Amir Abu Zikary El Sayed aabozikry@yahoo.com 00201016326544 Egypt / Bamha / 10 el gaish street
City Postal code Country Position/Affiliation
Banha 333257 Egypt lecturer of anesthesia and surgical intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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