Plain English Summary
Background and study aims
Breast cancer is the most common cancer in women that requires frequent surgery. Nearly 40% breast surgery patients experience significant amount of pain just after surgery, reflecting the inadequacy of conventional pain management.Most of the responses of the human body to post-surgical pain (pain after surgery) have been proven to be detrimental to the patient’s homeostasis (normal body function) and recovery. Furthermore, up to 50% of breast cancer patients suffer from chronic (long lasting) pain after surgery, and inadequate pain relief (analgesia) is considered to be a reason for this. A number of therapeutic measures have been accepted as a part of a “multi-modal” approach to postoperative pain control. Thoracic paravertebral block (PVB) is used for pain relief after chest (thoracotomy) surgery and mastectomy (removal of the breast). PVB can provide profound, long-lasting deafferentation (blocking or destroying nerve cells that cause pain). Unlike general anesthesia, PVB can provide postoperative analgesia which much more effective than other forms of pain relief. It can also lead to less nausea and vomiting, a shorter recovery time, and earlier discharge from hospital. The use of PVB in patients undergoing ambulatory (outpatient) breast surgery has a cost-saving potential. Fentanyl is a synthetic (man-made) opioid with a short-acting pain killing effect that is suitable to be applied directly to the skin. The aim of this study is to study the effect of transdermal fentanyl (that is, fentanyl given though the skin) via a method called the transdermal therapeutic system (TTS). The aim of this study is to investigate the effect of transdermal fentanyl as adjuvant to paravertebral block for pain control in breast cancer surgery.
Who can participate?
Women with breast cancer scheduled for surgery.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given a
Patients will be randomly classified using sealed envelope into two equal groups each of 25transdermal fentanyl (TDF) patch three hours before their operation. Paravertebral block (PVB) is also be performed before the patient is given general anesthesia. Those in group 2 are given the PVB only. Heart rate and blood pressure are monitored before and during surgery.After surgery patients are transferred to the post-anesthesia care unit (PACU) and are monitored for vital signs, level of sedation and pain.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
National Cancer Institute, Cairo University
When is the study starting and how long is it expected to run for?
March 2016 to June 2016
Who is funding the study?
National Cancer Institute, Cairo University
Who is the main contact?
Dr Ahmed Bakir
ahmed_bakir77@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ahmed Bakir
ORCID ID
Contact details
National Cancer Institute
Cairo University
Kasr Al Eini Street
Fom El Khalig
Cairo
11796
Egypt
+201115661922
ahmed_bakir77@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
201516015.2
Study information
Scientific title
Transdermal fentanyl patch as an adjuvant to paravertebral block for pain control after breast cancer surgery : a randomized double blind controlled trial
Acronym
Study hypothesis
The aim of this work is to study the effect of transdermal fentanyl as adjuvant to paravertebral block for pain control in breast cancer surgery.
Ethics approval
Cairo University National Cancer Institutional Review Board, 22/03/2016, ref: 201516015.2
Study design
Observational study 3 months duration arandomized double blind controlled trial
Primary study design
Observational
Secondary study design
Nested case-control study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
No participant information sheet available
Condition
Postoperative pain (breast cancer patients)
Intervention
Patients will be randomly classified using sealed envelope into two equal groups each of 25 patients.
1. Group A: (TDF & PVB)
Patients of this group will obtain a transdermal fentanyl (TDF) patch 25 μg/h three hours before induction of anesthesia. Paravertebral block (PVB) will be performed using 20 mL of bupivacaine 0.25% then general anesthesia will be induced.
2. Group B: (PVB)
Paravertebral block will be performed using 20 mL of bupivacaine 0.25% then general anesthesia will be induced.
Heart rate and blood pressure will be measured before surgery and during the procedure itself.
After surgery patients will be transferred to the post-anesthesia care unit (PACU) and will be monitored for vital signs (heart rate, blood pressure, respiratory rate, and SPO2), level of sedation and pain.
Intervention type
Drug
Phase
Drug names
Fentanyl
Primary outcome measure
1. The time of the first request for analgesia post surgery
2. Total analgesic consumption in the first 48 hours after surgery
Secondary outcome measures
1. Postoperative adverse effects such as nausea, vomiting, hypotension, bradycardia, and cardiac arrhythmia
2. Postoperative complications of the block including accidental pneumothorax and vascular puncture
Overall trial start date
22/03/2016
Overall trial end date
22/06/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Female with cancer breast with physical status ASA 1-3 scheduled for cancer breast surgery
Participant type
Mixed
Age group
Mixed
Gender
Female
Target number of participants
50 participants
Participant exclusion criteria
Patients with:
1. Central neuropathy
2. Coagulopathy
3. Psychiatric illness
4. History of drug abuse
5. Liver or renal impairment
Recruitment start date
22/03/2016
Recruitment end date
22/06/2016
Locations
Countries of recruitment
Egypt
Trial participating centre
National Cancer Institute, Cairo University
Kasr Al Eini Street
Fom El Khalig
Cairo
11796
Egypt
Sponsor information
Organisation
National Cancer Institute, Cairo University
Sponsor details
Kasr Al Eini Street
Fom El Khalig
Cairo
11796
Egypt
+201115661922
ahmed_bakir77@yahoo.com
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
National Cancer Institute, Cairo University
Alternative name(s)
NCI
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Egypt
Results and Publications
Publication and dissemination plan
Intention to publish date
22/06/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/29033716 (added 24/01/2019)