Does adding intravenous dexamethasone to paravertebral block augment postoperative analgesia in breast cancer patients?
| ISRCTN | ISRCTN15920148 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15920148 |
| Secondary identifying numbers | 201617016.2p |
- Submission date
- 23/06/2017
- Registration date
- 29/06/2017
- Last edited
- 04/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
National Cancer Institute, Cairo University
Al Kasr Al Aini
Fom Al Khalig WA Deir an Nahas
Misr Al Qadimah
Cairo Governorate
Cairo
-
Egypt
| Phone | +20 111 566 1922 |
|---|---|
| ahmed_bakir77@yahoo.com |
Study information
| Study design | Observational prospective randomised placebo controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Intravenous dexamethasone augments the analgesic effect of paravertebral block for cancer breast surgery: a prospective randomised placebo-controlled study |
| Study objectives | The aim of this study is to evaluate if intravenous dexamethasone augments the analgesic effect of paravertebral block in breast cancer surgery. |
| Ethics approval(s) | Ethical Committee of National Cancer Institute, Cairo University, 18/6/2017, ref: 201617016 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | paravertebral nerve block, intravenous dexamethasone |
| Primary outcome measure | 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 study start date | 01/02/2017 |
| Completion date | 01/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Female |
| Target number of participants | 50 patients in 2 groups |
| Key inclusion criteria | 1. Patients for breast cancer surgery ASA1-3 2. Aged from 18-80 |
| Key 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 |
| Date of first enrolment | 01/03/2017 |
| Date of final enrolment | 01/08/2017 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Fom Al Khalig WA Deir an Nahas
Misr Al Qadimah
Cairo Governorate
Cairo
-
Egypt
Sponsor information
Hospital/treatment centre
Al Kasr Al Aini
Fom Al Khalig WA Deir an Nahas
Misr Al Qadimah
Cairo Governorate
Cairo
-
Egypt
| Phone | +20 111 566 1922 |
|---|---|
| ahmed_bakir77@yahoo.com | |
"ROR" |
https://ror.org/03q21mh05 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impact peer reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/12/2018 | Yes | No |
Editorial Notes
04/01/2019: Publication reference added.
12/07/2017: Internal review.
