The erector spinae plane block is non-inferior to paravertebral block with regards to pain relief and use of opioids in in breast cancer patients undergoing mastectomy with immediate reconstruction.
ID
Source
Brief title
Health condition
mastectomy with immediate reconstruction
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Mean difference in highest numerical rating score (NRS – a linear 11 point scale for self-reported pain) during admission in the recovery room - Difference in the ratio of the mean cumulative intravenous opioid dose administered during admission in the recovery room – converted to morphine equivalent dose (MEQ)
Secondary outcome
- Success rate as defined by satisfactory spread of local anaesthetic agents on ultrasound - Ease of procedure (self-reported by performer of block on scale of 1 - 5) - Total opioid dose administered on day 0 and on day 1 (converted to morphine equivalent dose (MEQ) - Highest reported NRS on day 0 and 1 - Incidence of complications of block (such as block failure, epidural hematoma, hemo- or pneumothorax and symptoms of toxicity of local anesthetics) - Patient satisfaction on a scale of 0 (extremely unsatisfied) tot 10 (extremely satisfied)
Background summary
In breast cancer treatment, surgery plays a central role in combination with chemotherapy, radiation and immunotherapy. Surgery may vary from conservative breast sparing interventions to large radical mastectomies with axillary lymph node dissection that require reconstructive (prosthetic) surgery. In many instances, reconstruction is not performed immediately, but immediate reconstruction is possible and offers many advantages to patients. The Antoni van Leeuwenhoek hospital performs a large proportion (77%) of mastectomies with immediate reconstruction in the Netherlands. The combination of mastectomy with immediate reconstruction in one operation offers an extra challenge with regards to pain control. Post-operative pain is often treated with opioids, which has systemic side effects (nausea and vomiting). Opioids also inhibit cell-mediated immunity, which is a principal defense against cancer. Regional anesthetic techniques are often performed to reduce opioid consumption and enhance postoperative recovery. The current standard for regional anesthesia for breast surgery is the paravertebral block (PVB). This technique has the potential for severe complications such as epidural hematoma, hemo- or pneumothorax. The erector spinae plane block (ESP) was first described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain. The site of injection is distant from the pleura, major blood vessels, and spinal cord; hence, the ESP block has relatively few contraindications and has therefore been suggested as an alternative to PVB when contra-indications, such as a bleeding diathesis, are present. Multiple studies have shown a decrease in opioid consumption in patients undergoing mastectomy, when ESP was compared to placebo. ESP has also been shown to be non-inferior to PVB for pain relief in patients undergoing thoracotomy. To date, only two studies have compared ESP to PVB for breast surgery, with conflicting results. In this study, we would like to investigate whether ESP can be considered non-inferior to PVB with regards to pain relief and use of opioids.
Study objective
The erector spinae plane block is non-inferior to paravertebral block with regards to pain relief and use of opioids in in breast cancer patients undergoing mastectomy with immediate reconstruction.
Study design
- recovery room and on day 0 and 1 post-operative
Intervention
Erector spinae plane block
Inclusion criteria
- Adult patients (18 years of age or older) - ASA I-III - Patients scheduled for elective unilateral mastectomy followed by direct reconstruction - Ability to give written and oral informed consent
Exclusion criteria
- Patient refusal - Non-elective surgery - Any contraindication to paravertebral block (including bleeding diathesis, coagulopathy, severe pulmonary disease ) - Allergy to amide-linked local anaesthetics - Cardiac conductivity disorders (e:g: 2nd and 3rd AV-block) - Severe spinal malformations or history of extensive spine surgery - A history of spinal cord injury - Known psychiatric disorder - Chronic pain patients or patients already using opioids pre-operatively - Infection of the skin at the site of needle puncture area - Inability to give oral and written informed consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8771 |
| CCMO | NL75733.031.20 |
| OMON | NL-OMON50985 |