Postoperative NRS pain scores in the breast after BCS are lower in women who receive a preoperative PECS II block than in women who receive a sham block.
ID
Source
Brief title
Condition
- Breast disorders
Health condition
Breast cancer
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
NRS pain scores in the breast after breast conserving surgery
Secondary outcome
- Postoperative NRS pain scores in the axilla. - Intraoperative need of opiates (milligrams). - Postoperative need of opiates or other pain killers (milligrams). - Patient-reported chronic (> 12 weeks) pain (yes/no). - Patient satisfaction, measured by the BREAST-Q BCT. - Postoperative time that women need to be observed in the recovery room (minutes). - Time until women are discharged from the hospital (hours). - Use of additional anti-emetics for PONV (yes/no). - Vomiting (yes/no). - Operating time (minutes). - Complications (wound infection rate, hematoma, abscess, pneumothorax).
Background summary
Rationale: Acute postoperative pain is a risk factor for the development of persistent or chronic pain after surgery. 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 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 breast conserving surgery (BSC). Objective: To evaluate the analgesic effects of intraoperative PECS-II block in addition to general anaesthesia for breast conserving surgery (compared to a placebo block). Study design: A prospective randomized, double blind placebo-controlled trial. Study population: Women > 18 years old with breast cancer that are scheduled for BCS in the St. Antonius Hospital in the Netherlands. Intervention: In group 1 we will conduct an ultrasound guided PECS II-block with 30 ml levobupivacaine 0.5% with a maximum of 3 ml/kg. Group 2 receives a sham block consisting of 30 ml sodiumchloride (NaCl) 0.9%. Main study parameters/endpoints: Postoperative pain in the breast and the axilla. Secondary endpoints: intraoperative need of opiates, postoperative need of opiates or other analgesics (pain killers), chronic pain, breast-related patient satisfaction, postoperative time spent in the recovery room, hospital admission time, postoperative vomiting and nausea, operating time and wound infection. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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 its registered indication and the dose is within safety margins. The subjects undergo the PECS-II block under general anaesthesia with standard anaesthetic monitoring. They are not exposed to injections while awake. Patients in group 1 might benefit from participation as they might experience less postoperative pain and might need less postoperative analgesics.
Study objective
Postoperative NRS pain scores in the breast after BCS are lower in women who receive a preoperative PECS II block than in women who receive a sham block.
Study design
All patients will be given a study diary. In this personal book, the NRS will be registered at the following times after termination of the surgery: 30 minutes, 1 hour, 2 hours and 4 hours. The NRS is filled in on the form by either the nurse in the recovery room or the nurse in the ward. After 8, 24, 48 hours and 1, 2, 3, 4, 6 and 12 weeks the NRS is filled on the form by the patient herself. Preoperatively and 6 weeks postoperatively, the patients also fill out the following modules of the BREAST-Q BCT in their diary: psychosocial wellbeing, sexual wellbeing, satisfaction with breasts and physical wellbeing. After completing the questions in this diary, patients can send their diary back to the hospital for free with the included envelope. In order to find out whether patients have chronic pain, we will contact patients after 6 months to follow-up on their pain scores with the NRS and the four BREAST-Q BCT questionnaires.
Intervention
PECS II block with levobupivacaine versus sham PECS II block with NaCl
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following 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
A potential subject who meets any of the following criteria will be excluded from participation in this study: - Women < 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
IPD sharing statement
Postbus 2500
3430 EM Nieuwegein
088 320 8784
info@mec-u.nl
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 | NL8317 |
| Other | MEC-U : MEC-U: R19.087 |
| EudraCT | 2019-004039-21 |
| CCMO | NL71759.100.19 |
| OMON | NL-OMON50121 |