Plain English Summary
Background and study aims
Breast cancer normally requires surgery as a treatment, either to remove a lump or to remove the entire breast tissue. An important aspect of surgery is the anesthetic in order to not feel pain during the operation. There are different types of anesthetics that have different benefits. A paravertebral block (PVB) is a method that provides an analgesic effect (pain control) with less sedation (a medication to put people to sleep). Adding an intravenous dexamethasone (a steroid medication that is added to the veins through a needle) could be beneficial to patients to help control inflammatory conditions when given in addition to a PVB. The aim of this study is to evaluate if intravenous dexamethasone augments the analgesic effect of paravertebral block in breast cancer surgery.
Who can participate?
Adults aged 18-80 who are undergoing surgery for breast cancer
What does the study involve?
Participants are randomly allocated to one of two groups. Participants receive the standard operating care prior to surgery. Those in the first group receive a paravertebral nerve block as well as intravenous dexamethasone added to it. Those in the second group receive the PVB only. All participants receive standard care. Participants are observed every two hours for 72 hours after surgery for pain, nausea, vomiting, side effects, and to see if any other pain medication is taken.
What are the possible benefits and risks of participating?
Participants may benefit from a longer lasting analgesic effect. There are no risks with participating.
Where is the study run from?
National Cancer Institute, Cairo University (Egypt)
When is the study starting and how long is it expected to run for?
March 2017 to September 2017
Who is funding the study?
National Cancer Institute, Cairo University (Egypt)
Who is the main contact?
Dr Ahmed Bakeer
ahmed_bakir77@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ahmed Bakeer
ORCID ID
Contact details
National Cancer Institute
Cairo University
Al Kasr Al Aini
Fom Al Khalig WA Deir an Nahas
Misr Al Qadimah
Cairo Governorate
Cairo
-
Egypt
+20 111 566 1922
ahmed_bakir77@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
201617016.2p
Study information
Scientific title
Intravenous dexamethasone augments the analgesic effect of paravertebral block for cancer breast surgery: a prospective randomised placebo-controlled study
Acronym
Study hypothesis
The aim of this study is to evaluate if intravenous dexamethasone augments the analgesic effect of paravertebral block in breast cancer surgery.
Ethics approval
Ethical Committee of National Cancer Institute, Cairo University, 18/6/2017, ref: 201617016
Study design
Observational prospective randomised placebo controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Female patients undergoing surgery for breast cancer
Intervention
Participants are randomly allocated to one of two groups. Participants receive the standard operating care prior to surgery.
Intervention group: Participants in this group receive a paravertebral nerve block (PVB) as well as an intravenous dexamethasone added to it. Surgery is then continued as to the standard level of care.
Control group: Participants receive the PVB and the standard care.
Participants are observed every two hours for 72 hours post-operatively for pain, nausea, vomiting, if any other analgesic taken and when sensation returns. Any side effects, nausea or vomiting are recorded for 72 hours.
Intervention type
Drug
Phase
Not Applicable
Drug names
paravertebral nerve block, intravenous dexamethasone
Primary outcome measures
1. Pain is measured using the visual analogue score (VAS) at every two hours during the 72 hours post operation
2. Time of return sensation is measures using patient interviews at every two hours during the 72 hours post operation
3. Analgesic taken is measured using patient records at every two hours during the 72 hours post operation
Secondary outcome measures
1. Nausea is measured using patient records at every two hours during the 72 hours post operation
2. Vomiting is measured using patient records at every two hours during the 72 hours post operation
3. Side effects and complications measured using patient records at every two hours during the 72 hours post operation
Overall trial start date
01/02/2017
Overall trial end date
01/09/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients for breast cancer surgery ASA1-3
2. Aged from 18-80
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
50 patients in 2 groups
Participant exclusion criteria
1. Coagulopathy
2. Allergy to drugs in study
3. Refusal to participate
4. Severe renal, hepatic or lung disease
5. Chronic opioid use
Recruitment start date
01/03/2017
Recruitment end date
01/08/2017
Locations
Countries of recruitment
Egypt
Trial participating centre
National Cancer Institute, Cairo University
Al Kasr Al Aini
Fom Al Khalig WA Deir an Nahas
Misr Al Qadimah
Cairo Governorate
Cairo
-
Egypt
Sponsor information
Organisation
National Cancer Institute, Cairo University
Sponsor details
Al Kasr Al Aini
Fom Al Khalig WA Deir an Nahas
Misr Al Qadimah
Cairo Governorate
Cairo
-
Egypt
+20 111 566 1922
ahmed_bakir77@yahoo.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
National Cancer Institute, Cairo University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Ahmed Baker at ahmed_bakir76@yahoo.com.
Intention to publish date
01/08/2018
Participant level data
Available on request
Results - basic reporting
Publication summary