This study has been transitioned to CTIS with ID 2024-515183-30-00 check the CTIS register for the current data. The aim of this prospective randomized, double blind study is to evaluate the analgesic effects of pre-operative PECS II-block with (…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative (first 72 hours) NRS pain scores
Secondary outcome
- Postoperative painscores in the axilla
- Intraoperative need of opiates
- Postoperatieve need of opiates and other painkillers
- Chronic pain (>12 weeks)
- Satisfaction, measured by BREAST-Q mastectomy
- Time to discharge
- Postoperative nausea and vomiting (PONV)
Background summary
The pectoral nerve block type II (PECS II block) is an easy to perform,
superficial, peripheral nerve block. Previous literature shows that this block
is safe to perform with a positive effect on postoperative pain in patients
undergoing mastectomy. Currently the maximal duration of action of local
anesthesia is limited, causing insufficient pain relief after mastectomy. This
means some women start perceiving pain the night of the operation and need
opioids as analgesia. Side effects of opioids (i.e. postoperative nausea and
vomiting) are an important reason for a prolonged length of stay. Liposomal
bupivacaine is supposed to have analgesic effects up to 72 hours, due to
extended release.
Study objective
This study has been transitioned to CTIS with ID 2024-515183-30-00 check the CTIS register for the current data.
The aim of this prospective randomized, double blind study is to evaluate the
analgesic effects of pre-operative PECS II-block with (long-acting) liposomal
Bupivacaine versus (short-acting) Levobupivacaine for patients undergoing a
mastectomy.
Study design
Multicenter.
Prospective, randomized, double-blind.
Intervention
One arm receives a pre-operative PECS II-block with liposomal Bupivacaine prior
to mastectomy and the second arm receives a PECS II-block with Levobupivacaine.
Study burden and risks
When participating to this study, patients are asked to fill in a patient diary
with pain scores and medication use. We do not expect increased risks. We
expect that patients receiving a PECSII block with liposomal Bupivacaine will
have less pain after surgery.
Soestwetering 1
Utrecht 3543
NL
Soestwetering 1
Utrecht 3543
NL
Listed location countries
Age
Inclusion criteria
- Unilateral mastectomy
- Written informed consent
- Asa I-III
Exclusion criteria
- Age <18 jaar
- (Oncoplastic) breast conserving surgery
- Bilateral surgery
- Bleeding disorder or coagulopathy
- Chest wall deformity or infection of injection site
- Another (additional) nerve block (TPVB or epidural anesthesia)
- Autologous or implant based breast reconstruction
- Known allergy for levobupivacaine or local anesthetics from the amide group
- Known allergy or contra-indication for NSAIDs
- Chronic use of opiates preoperatively (>12 weeks)
- Previous breast surgery ipsi- or contralateral less than 5 years prior to
planned mastectomy (except diagnostic biospies)
- Not able to speak or understand the Dutch language fluently
- Pregnancy or breast feeding
- Psychological, neurological, familial, sociological or geographical factors
that could potentially hamper compliance with the study protocol
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-515183-30-00 |
| EudraCT | EUCTR2022-004128-16-NL |
| CCMO | NL83450.100.23 |