Condition category
Surgery
Date applied
23/06/2017
Date assigned
29/06/2017
Last edited
12/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

12/07/2017: Internal review.