The primary objective of this study is to compare analgesic efficacy of paravertebral block (PVB) with erector spinae plane block (ESPB) in patients undergoing BCS. Since post-operative pain is treated with analgesics we will both assess pain scores…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is reduction in NRS pain score and/or opioid use compared
with women undergoing standard care.
Secondary outcome
Secondary outcome measures are time to perform the procedure, patient
discomfort during the procedure, extend of sensory block, patient satisfaction
with post-operative analgesia, incidence of side-effects and complications.
Background summary
The incidence of breast cancer in women is high and still increasing.
Surgically treated breast cancer patients have one of the highest incidences of
chronic pain when compared to other cancer related surgery. Chronification of
postoperative pain is amongst other factors influenced by severe acute
postoperative pain. Locoregional techniques have gained popularity as an
adjunct to general anesthesia for breast cancer surgery (BCS), for their
ability to reduce acute postoperative pain with minimal side effects.
Study objective
The primary objective of this study is to compare analgesic efficacy of
paravertebral block (PVB) with erector spinae plane block (ESPB) in patients
undergoing BCS. Since post-operative pain is treated with analgesics we will
both assess pain scores and analgesic use in patients.
Study design
This prospective pilot study will follow 10 patients. Data of these patients
will be compared with data from 10 patients receiving the standard care for
this surgery, i.e. PVB. No randomization or blinding will take place.
Study burden and risks
ESPB is considered more safe than PVB since the risk of intra-arterial
injection, pneumothorax and hypotension are much more lower because of the
anatomic position of the injection site and because block can be placed under
ultrasound guidance. Patients participating in this study will not be subjected
to any additional risks other than the common risks for breast cancer surgery
and a combined general anesthesia and locoregional anesthesia technique.
Nistelrodeseweg 10
Uden 5406 PT
NL
Nistelrodeseweg 10
Uden 5406 PT
NL
Listed location countries
Age
Inclusion criteria
- >18 years old
- ASA I-III
- Written informed consent
Exclusion criteria
- Allergy or contra-indication for paracetamol, etoricoxib or oxycodone
- Chronic opioid use
- Known hypersensitivity or contraindication for local anesthetics
- Bleeding or infection at the puncture site
- Contraindications for regional anesthesia
- Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-000709-18-NL |
| CCMO | NL61106.091.17 |