Efficacy of Serratus Anterior Plane Block Mastectomy
1 other identifier
interventional
40
1 country
1
Brief Summary
Breast cancer is the main common cancer among females. . Inadequate control of pain may later develop into chronic pain syndrome (paraesthesias, phantom breast pain, and intercostobrachial neuralgia) in 25-40% of the patients .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2019
CompletedStudy Start
First participant enrolled
May 7, 2019
CompletedFirst Posted
Study publicly available on registry
May 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 12, 2020
February 1, 2020
7 months
May 6, 2019
February 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
time to first analgesic requirements in minutes
time to first analgesic requirements in minutes by the patient
change from base line for 24 hours
Study Arms (2)
GBM:( bupivacaine/magnesium sulphate)
ACTIVE COMPARATORserratus plane block will performed in the supine position under strict aseptic conditions before induction of anesthesia. GBM:( bupivacaine/magnesium sulphate): will receive bupivacaine 30 ml 0.25 and 500 mg magnesium sulphate
GBN: ( bupivacaine/nalpuphin)
ACTIVE COMPARATORserratus plane block will performed in the supine position under strict aseptic conditions before induction of anesthesia.. ( bupivacaine/nalpuphin):received bupivacaine 30 ml 0.25 % and nalpuphine 0.2mg/kg.
Interventions
serratus anterior plan block
Eligibility Criteria
You may qualify if:
- ASA I and II female patients, age 25-60 undergoing breast cancer surgery
You may not qualify if:
- Patient refusal
- Contraindications for regional blocks (eg. Infection at the injection site, coagulopathy)
- Allergy to the drugs used in the study
- Chronic pain therapy,
- BMI more than 30 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- doaa rashwanlead
Study Sites (1)
Faculty Of Medicine, Beni-Suef University
Banī Suwayf, 11391, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Doaa Rashwan, MD
Faculty of Medicine Beni-Suef University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant profesor Doaa Rashwan
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 10, 2019
Study Start
May 7, 2019
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
February 12, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- after registration for ever
- Access Criteria
- on the web page \-
the protocol