World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12615000669594
Date of registration: 29/06/2015
Prospective Registration: No
Primary sponsor: diab fuad hetta
Public title: Pectoralis-serratus interfascial plane block vs. paravertebral block for acute post-mastectomy pain
Scientific title: In modified radical mastectomy, does Pectoralis-serratus interfascial plane block, compared to paravertebral block, reduce postoperative opioid consumption?
Date of first enrolment: 25/11/2013
Target sample size: 50
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12615000669594.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial;  
Phase: 
Countries of recruitment
Egypt
Contacts
Name: Dr diab fuad hetta   
Address:  organization address: south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt Egypt
Telephone: +201091090009
Email: diabhetta25@gmail.com
Affiliation: 
Name: Dr diab fuad hetta   
Address:  organization address: south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt Egypt
Telephone: +201091090009
Email: diabhetta25@gmail.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Adult women, American Society of Anesthesiologists (ASA) physical status class I–III, scheduled for unilateral modified radical mastectomy (MRM) with axillary evacuation
Exclusion criteria: The exclusion criteria included patients with a known allergy to bupivacaine or morphine, bleeding disorders, anatomical abnormalities, infection in the paravertebral region, pregnancy, breast feeding, severe obesity (body mass index >35 kg/m2), a history of drug or alcohol abuse and patients suffering from chronic pain or regularly receiving analgesics.

Age minimum: 18 Years
Age maximum: No limit
Gender: Females
Health Condition(s) or Problem(s) studied
Anaesthesiology - Anaesthetics
Post-operative pain following modified radical mastectomy;
Post-operative pain following modified radical mastectomy
Surgery - Other surgery
Intervention(s)
Before induction of anesthesia (pre-incision), for group PS, we will give pectoralis-serratus interfascial plane block, in which we will inject 10 ml of bupivacaine 0.25% between pectoralis major and minor muscles around the pectoral nerve. and another 20 ml of bupivacaine 0.25% between pectoralis minor and serratus anterior muscles at the level of rib 4 under ultrasonographic guidence
Primary Outcome(s)
postoperative 24 h morphine consumption recorded on patient chart[24 h post-operative]
Secondary Outcome(s)
The time to rescue analgesic recorded on patient chart [24 h post-operative]
Intensity of pain measured by VAS score recorded on patient chart[0 h (after recovery from anesthesia), 2 h, 4h, 8h, 16 h, 24 h post-operative]
Secondary ID(s)
none
Source(s) of Monetary Support
Secondary Sponsor(s)
noha esmail ibrahim
Ethics review
Status: Approved
Approval date:
Contact:
SECI-IRB IORG0006563
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history