The aim of this prospective randomized, double blind placebo-controlled trial study is to evaluate the analgesic effects of preoperative PECS-II block in addition to general anaesthesia for breast conserving surgery compared to a placebo block. Our…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess whether postoperative NRS pain scores in the breast after BCS is
lower in women who receive a preoperative PECS II block than in women who
receive a sham block.
Secondary outcome
- To assess whether postoperative NRS pain scores in the axilla after BCS is
lower in women who receive a preoperative PECS II block than in women who
receive a sham block.
- To assess whether the intraoperative need of opiates in women who undergo BCS
is lower in women who receive a preoperative PECS II block than in women who
receive a sham block.
- To assess whether the postoperative need of opiates or other pain killers
after BCS is lower in women who receive a preoperative PECS II block than in
women who receive a sham block.
- To assess whether women have less chronic pain (> 12 weeks) from BCS after
receiving a preoperative PECS II block than women who receive a sham block.
- To assess whether women are more satisfied after receiving a preoperative
PECS II block than women who receive a sham block, measured by the BREAST-Q BCT.
- To assess whether the postoperative time that women need to be observed in
the recovery room after BCS is shorter in women who receive a preoperative PECS
II block than in women who receive a sham block.
- To assess whether the time until discharge from the hospital after BCS is
shorter in women who receive a preoperative PECS II block than in women who
receive a sham block.
- To assess whether women experience less postoperative nausea and vomiting
(PONV) after BCS when receiving a preoperative PECS II block compared to those
who receive a sham block.
- To assess the difference in operating time in women who undergo BCS is no
longer in women who receive a preoperative PECS II block than in a random
sample of women who did not receive a PECS II block.
- To assess whether women who undergo BCS with a preoperative PECS II block do
not have more wound infections or other complications than women in a random
sample who did not receive a PECS II block before their breast conserving
surgery.
Background summary
Breast cancer remains the most common cancer in women. Nowadays, the standard
of care for early stage breast cancer is breast conserving surgery (BCS, or
lumpectomy) and sentinel lymph node biopsy (SLNB), followed by whole-breast
radiotherapy. Long-term survival rates are similar with this treatment as
radical mastectomy.
With the introduction of better screening programs and more effective treatment
modalities, the survival of breast cancer patients has improved substantially
over the past decades. Therefore, the focus of breast cancer patients and
physicians is slowly expanding to long-term side effects and quality of life.
An important, invalidating long-term complication of breast cancer surgery is
chronic pain, compromising approximately two thirds of women who had breast
cancer surgery. Besides type of surgery and radiotherapy, acute postoperative
pain is a risk factor for the development of persistent or chronic pain after
breast cancer surgery.
Therefore, several regional anesthesia techniques to decrease postoperative and
persistent pain after breast surgery have been developed (e.g., thoracic
epidural, intercostal nerve or thoracic paravertebral block). However, these
blocks can cause serious complications such as intrathecal spread, nerve damage
or epidural hematoma. Moreover, not all anesthetic physicians feel comfortable
applying these blocks.
The pectoral nerve block type II (PECS II block) is an easy to perform,
superficial, peripheral nerve block that is ultrasound-guided, first introduced
in 2012. The PECS II block is a modified PECS I block. A local anesthetic is
placed between the pectoralis minor and the serratus anterior muscles (blocking
the intercostal and intercostobrachial nerves) and subsequently between the
pectoralis major and minor muscles (blocking the lateral and medial pectoral
nerves). Previous literature shows that this block is safe to perform with
great effect on postoperative pain relief in patients undergoing mastectomy.
However, little is known on the effects of the PECS II block in patients
undergoing BCS. Kim et al. (2018) were the first to describe the effects of
PECS II in BCS patients. They reported a statistically significant reduction in
pain intensity and opioid requirements for 24 hours after BCS and SNB, but
questioned the clinical relevance of these findings.
Study objective
The aim of this prospective randomized, double blind placebo-controlled trial
study is to evaluate the analgesic effects of preoperative PECS-II block in
addition to general anaesthesia for breast conserving surgery compared to a
placebo block. Our primary objective is to assess if women who receive a
preoperative PECS II block have lower average postoperative pain scores in the
breast after breast conserving surgery than women who receive a sham block.
Secondary we will evaluate the difference in postoperative pain score in the
axilla, intraoperative need of opiates, postoperative need of opiates or other
pain killers, chronic pain, breast-related patient satisfaction, postoperative
time spend in the recovery room, hospital admission time, postoperative nausea,
operating time and wound infection.
Study design
Single center. Prospective, randomized, double-blind and placebo-controlled.
One arm receives a pre-operative PECS II block prior to breast-conserving
surgery and the second arm receives a sham block with NaCl for BCS.
Intervention
One arm receives a pre-operative PECS II block prior to breast-conserving
surgery and the second arm receives a sham block with NaCl for BCS.
Study burden and risks
The sham intervention will not lead to physical or mental suffering, because
the administration of the sham block is performed in the operating room after
induction of general anesthesia. The risks to be taken do not exceed the
humanitarian importance of the problem, because the sham block does not contain
any harmful substances (NaCl only) and because a PECS block has been used
safely. Previous experience and literature prove this. Based on literature from
the PECS block procedures, no complications are associated with the PECS block.
We believe that the benefits of a PECS II block can be large and
multi-dimensional.
Subjects undergo a procedure which is generally considered safe, since the
block is performed ultrasound guided by with trained physicians, away from the
neuraxis branch. We use medication within the registered indication and the
dose is within the safety margins. The subjects receive the PECS II block under
general anesthesia with standard anesthetic monitoring. We do not expose them
to injections while they are awake. Patients in group 1 may benefit from
participation because they may experience less postoperative (acute and
chronic) pain and may require fewer postoperative painkillers.
The time load on filling out the patient diary is minimal and does not last
longer than 10 minutes at a time. Patients do not need to schedule additional
outpatient visits for this study.
In view of the above, we believe that the benefits outweigh the potential
burden of risk.
Kinderdijkstraat 26-2
Amsterdam 1079 GJ
NL
Kinderdijkstraat 26-2
Amsterdam 1079 GJ
NL
Listed location countries
Age
Inclusion criteria
- Female gender.
- Unilateral breast conserving surgery.
- Written informed consent according to ICH/GCP and national regulations.
- ASA (American Society of Anesthesiologists) Class I-III .
Exclusion criteria
- Women above 18 year old.
- Bilateral surgery.
- Bleeding disorder or coagulopathy.
- Chest wall deformity or infection of injection site.
- Another (additional) nerve block (such as TPVB or epidural anesthesia).
- Oncoplastic breast conserving surgery.
- Autologous or implant based breast reconstruction.
- Known allergy for levobupivacaine or local anesthetics from the amide group.
- Chronic use of analgesics / opiates preoperatively (> 12 weeks).
- Previous breast surgery ipsi- or contralateral (except diagnostic biopsies).
- Not able to speak or understand the Dutch language fluently.
- Palliative surgery.
- Metastatic disease.
- Pregnancy or breast feeding.
- Psychological, neurological, familial, sociological or geographical factors
that could potentially hamper compliance with the study protocol.
- Other concurrent solid tumor.
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-004039-21-NL |
| CCMO | NL71759.100.19 |
| Other | NL8317 |
| OMON | NL-OMON28887 |