Postoperative pain control after breast surgery
| ISRCTN | ISRCTN76105318 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76105318 |
| Secondary identifying numbers | 201516015.2 |
- Submission date
- 26/04/2016
- Registration date
- 30/06/2016
- Last edited
- 24/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
National Cancer Institute, Cairo University
Kasr Al Eini Street
Fom El Khalig
Cairo
11796
Egypt
| Phone | +201115661922 |
|---|---|
| ahmed_bakir77@yahoo.com |
Study information
| Study design | Observational study 3 months duration arandomized double blind controlled trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Nested case-control study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | Transdermal fentanyl patch as an adjuvant to paravertebral block for pain control after breast cancer surgery : a randomized double blind controlled trial |
| Study objectives | 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(s) | Cairo University National Cancer Institutional Review Board, 22/03/2016, ref: 201516015.2 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | 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 study start date | 22/03/2016 |
| Completion date | 22/06/2016 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Female |
| Target number of participants | 50 participants |
| Key inclusion criteria | Female with cancer breast with physical status ASA 1-3 scheduled for cancer breast surgery |
| Key exclusion criteria | Patients with: 1. Central neuropathy 2. Coagulopathy 3. Psychiatric illness 4. History of drug abuse 5. Liver or renal impairment |
| Date of first enrolment | 22/03/2016 |
| Date of final enrolment | 22/06/2016 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Fom El Khalig
Cairo
11796
Egypt
Sponsor information
University/education
Kasr Al Eini Street
Fom El Khalig
Cairo
11796
Egypt
| Phone | +201115661922 |
|---|---|
| ahmed_bakir77@yahoo.com | |
"ROR" |
https://ror.org/03q21mh05 |
Funders
Funder type
University/education
Government organisation / National government
- Alternative name(s)
- NCI
- Location
- Egypt
Results and Publications
| Intention to publish date | 22/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2017 | 24/01/2019 | Yes | No |
Editorial Notes
24/01/2019: Publication reference added
17/01/2018: The principal investigator confirmed the study dates.
