Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000669594
Ethics application status
Approved
Date submitted
31/05/2015
Date registered
29/06/2015
Date last updated
29/06/2015
Type of registration
Retrospectively registered

Titles & IDs
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?
Secondary ID [1] 286834 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain following modified radical mastectomy 295219 0
Condition category
Condition code
Anaesthesiology 295466 295466 0 0
Anaesthetics
Surgery 295644 295644 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 291998 0
Treatment: Drugs
Comparator / control treatment
Before induction of anesthesia (pre-incision), for group PV, we will give thoracic paravertebral block in which we will inject 7 ml of bupivacaine 0.25% at each level (the level of T2, T4 and T6) under ultrasonographic guidence
Control group
Active

Outcomes
Primary outcome [1] 295198 0
postoperative 24 h morphine consumption recorded on patient chart
Timepoint [1] 295198 0
24 h post-operative
Secondary outcome [1] 315027 0
The time to rescue analgesic recorded on patient chart
Timepoint [1] 315027 0
24 h post-operative
Secondary outcome [2] 315421 0
Intensity of pain measured by VAS score recorded on patient chart
Timepoint [2] 315421 0
0 h (after recovery from anesthesia), 2 h, 4h, 8h, 16 h, 24 h post-operative

Eligibility
Key inclusion criteria
Adult women, American Society of Anesthesiologists (ASA) physical status class I–III, scheduled for unilateral modified radical mastectomy (MRM) with axillary evacuation
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/11/2013
Actual
25/11/2013
Date of last participant enrolment
Anticipated
1/12/2014
Actual
27/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 6921 0
Egypt
State/province [1] 6921 0

Funding & Sponsors
Funding source category [1] 291384 0
Self funded/Unfunded
Name [1] 291384 0
Country [1] 291384 0
Primary sponsor type
Individual
Name
diab fuad hetta
Address
organization address: south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt
Country
Egypt
Secondary sponsor category [1] 290060 0
Individual
Name [1] 290060 0
noha esmail ibrahim
Address [1] 290060 0
organization address: faculty of medicine, 1 university st., assuit university, assuit city,71111, egypt
Country [1] 290060 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292940 0
SECI-IRB IORG0006563
Ethics committee address [1] 292940 0
Ethics committee country [1] 292940 0
Egypt
Date submitted for ethics approval [1] 292940 0
Approval date [1] 292940 0
01/09/2013
Ethics approval number [1] 292940 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57718 0
Dr diab fuad hetta
Address 57718 0
organization address: south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt
Country 57718 0
Egypt
Phone 57718 0
+201091090009
Fax 57718 0
Email 57718 0
[email protected]
Contact person for public queries
Name 57719 0
diab fuad hetta
Address 57719 0
organization address: south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt
Country 57719 0
Egypt
Phone 57719 0
+201091090009
Fax 57719 0
Email 57719 0
[email protected]
Contact person for scientific queries
Name 57720 0
diab fuad hetta
Address 57720 0
organization address: south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt
Country 57720 0
Egypt
Phone 57720 0
+201091090009
Fax 57720 0
Email 57720 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePectoralis-serratus interfascial plane block vs thoracic paravertebral block for unilateral radical mastectomy with axillary evacuation.2016https://dx.doi.org/10.1016/j.jclinane.2016.04.003
N.B. These documents automatically identified may not have been verified by the study sponsor.