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.: PACTR202112739714566 Date of Approval: 07/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study between intraoperative and postoperative analgesic effect of thoracic paravertebral nerve block and pectoral nerve block in patient undergoing modified radical mastectomy.
Official scientific title Comparative study between intraoperative and postoperative analgesic effect of thoracic paravertebral nerve block and pectoral nerve block in patient undergoing modified radical mastectomy.
Brief summary describing the background and objectives of the trial Modified radical mastectomy is associated with considerable acute postoperative pain and restricted shoulder mobility. If this acute pain is neglected most patient will develop chronic post-mastectomy pain, which reduces quality of life. Regional anesthesia using ultrasound- guided paravertebral nerve block or pectoral nerve block has become an ideal addition to general anesthesia for providing analgesia after breast cancer surgery. In this study we compare between both regional techniques regarding safety and efficacy.
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 In this study we compared between two different regional nerve block techniques regarding safety and efficacy in reducing intraoperative and postoperative pain
Anticipated trial start date 28/02/2018
Actual trial start date
Anticipated date of last follow up 28/02/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group pectoral nerve block 0.2 mL/kg of 0.25% bupivacaine the block was done intraoperative and assessment last for 24 hours postoperatively The goal of the Pecs II block is to infiltrate two fascial compartments by dividing the dose of local anesthetic (0.2 mL/kg of bupivacaine 0.25 ) between the pectoral nerves (the pectoral fascia and clavipectoral fascia) and under the pectoralis minor muscle (between the clavipectoral fascia and the superficial border of the serratus muscle). Block will be performed with the patient in supine position after intubation, placing the ipsilateral upper limb in abduction position with a 22-gauge spinal needle using ultrasound machine. The main landmarks to identify the first point of injection under US guidance are the pectoralis major and pectoralis minor muscles and the pectoral branch of the thoracoacromial artery. The operator locates the coracoid process on US in the paramedian sagittal plane. The transducer is rotated slightly from the proximal and medial side toward the lateral side (ie, the caudal border of the transducer is moved laterally, while the proximal border remains unchanged). The proper fascial plane is confirmed by hydrodissection to open the space between the pectoralis muscles. The second injection is made at the anterior axillary line at the level of the third rib between pectoralis minor and serratus anterior muscles. 15 Active-Treatment of Control Group
Experimental Group thoracic paravertebral nerve block 0.2 mL/kg of 0.25% bupivacaine the block was done intraoperative and assessment last for 24 hours postoperatively ultrasound-guided PVB is carried out with the patients in the lateral position after intubation. It is performed unilaterally with ultrasound guidance on the surgical side with a 22-gauge spinal needle. The linear transducer is placed longitudinally parallel and medially in search of the spinous process of T4. Then, the probe is translated laterally in search of the transverse process. Between the bright hyperechoic cortices of the transverse process and the underlying acoustic shadow, costotransverse ligament will be delineated; paravertebral space is confirmed by viewing the CTL and the underlying echogenic line (pleura). The needle is advanced in the plane, and LA (0.2 mL/kg of 0.25% bupivacaine) is deposited in the paravertebral space 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Female patient of ASA II. 2) Age range between 18-65 years. 3) Patient will undergo modified radical mastectomy under general anaesthesia. 4) BMI < 40. 1) Patient’s refusal. 2) Allergic reactions to local anesthetics. 3) Patients with infection at the block site. 4) Patients with coagulopathy. 5) Patients with any organ dysfunction. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 28/02/2018 research ethics committee at faculty of medicine of ain shams university
Ethics Committee Address
Street address City Postal code Country
38 Abbassia Square, Next to Al-Nour Mosque cairo 01234 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure in this study will be pain scores using VAS (0–10, with 0 as no pain and 10 being maximum possible pain) in the post-anaesthesia care unit at time 0 (just after extubation), 2, 4, 6, 12 and 24 h by an investigator blinded to the group assignment. 24 hours postoperative
Secondary Outcome The secondary outcome measures included the duration of post-operative analgesia, that is, time to first analgesic request from the time of giving block and the number of supplemental analgesic requirements. . All the patients will be also evaluated for any complications arising, for example, LA toxicity, vascular puncture, pleural puncture and pneumothorax. intraoperative and 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospitals 56 Ramses Street, Abbasia cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mostafa Adel Mohamed 18 Arslan street shoubra cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ain shams university hospitals 56 ramses street cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moustafa Adel mostafaadel80@gmail.com 01008117330 18 Arslan street shouba
City Postal code Country Position/Affiliation
cairo Egypt assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elhenawy anahenno@yahoo.com 01227461022 56 Ramses street
City Postal code Country Position/Affiliation
cairo Egypt professor
Role Name Email Phone Street address
Public Enquiries Dalia Elfawy daliamfawy@yahoo.com 01006211702 56 ramses street
City Postal code Country Position/Affiliation
cairo Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all individual participant data were collected and will be available immediately following publication for any one who wishes to access the data Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol data will be available immediately following publication for any one who wishes to access the data open access through ain shams journal of anesthesia once being published
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 30/11/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 30/11/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information