Breast Cancer
Conditions
Keywords
mastectomy
Brief summary
This trial will include patients undergoing radical mastectomy under general anesthesia. One group of patients will receive a pectoral nerve block, done by the anesthetist under ultrasound guidance at the beginning of the invervention. The other group will receive the a wound infiltration at the end of the intervention, done by the surgeon. Investigators will compare acute pain-related outcomes and chronic pain at 3 and 6 months postoperatively.
Detailed description
Mastectomies are associated with moderate to severe postoperative pain. In addition to general anesthesia, different methods of locoregional anesthesia exist to treat postoperative pain, amongst others a pectoral nerve block. This block consists in injecting local anesthetic between the muscles of the thoracic wall and is done under ultrasound guidance. Over the last few years, the pectoral nerves block has become a recognized option for the treatment of acute post-mastectomy pain and it is routinely performed in addition to general anesthesia. Data indicates that pectoral nerve blocks are effective for the treatment of postoperative pain during the first 24 hours after mastectomy, when compared to no block. However, the analgesic efficacy of a pectoral nerve block has never systematically compared to that of wound infiltration with local anesthetics, done by the surgeon at the end of the intervention. Such an infiltration is also currently employed. In our study randomize patients undergoing mastectomy under general anesthesia will be randomized to receive either an ultrasound-guided pectoral nerve block with 30 mL of local anesthetic (group PECS) or a wound infiltration with 30 mL of local anesthetic (group infiltration). Investigators will assess different pain-related outcomes over the first 24 postoperative hours, together with potential block-related side effects and patient satisfaction. Chronic postoperative pain at 3 and 6 months postoperatively will also be assessed. Both patients and outcome assessors will be blinded to group allocation.
Interventions
OTHERPECS block
Ultrasound-guided PECS block before surgical incision with 30 mL bupivacaine 0.5 %
OTHERLocal infiltration
Wound infiltration at the end of surgery with with 30 mL bupivacaine 0.5 %
Sponsors
University of Lausanne Hospitals
Hôpital du Valais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants, care providers and outcome assessors will be blinded.
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing unilateral mastectomy * American Society of Anesthesiology Physical Status I-III * Age ≥ 18
Exclusion criteria
* Contraindications to regional anesthesia, such as infection at the surgical site * Pregnancy * History of alcohol or drug dependence/abuse * History of long term opioid intake * Chronic pain disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption | first 24 postoperative hours | Cumulative intravenous morphine consumption (mg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first analgesic request | 24 hours postoperatively | Time between end of surgery and first analgesic request by patient, in minutes |
| Pain score on movement at 12 hours postoperatively | 12 hours postoperatively | Numeric rating scale from 0 = no pain to 10 = worst imaginable pain |
| Pain score at rest at 2 hours postoperatively | 2 hours postoperatively | Numeric rating scale from 0 = no pain to 10 = worst imaginable pain |
| Pain score on movement at 24 hours postoperatively | 24 hours postoperatively | Numeric rating scale from 0 = no pain to 10 = worst imaginable pain |
| Pain score at rest at 24 hours postoperatively | 24 hours postoperatively | Numeric rating scale from 0 = no pain to 10 = worst imaginable pain |
| Pain score on movement at 2 hours postoperatively | 2 hours postoperatively | Numeric rating scale from 0 = no pain to 10 = worst imaginable pain |
| Pain score at rest at 12 hours postoperatively | 12 hours postoperatively | Numeric rating scale from 0 = no pain to 10 = worst imaginable pain |
Contacts
Primary ContactSina Grape, MD
Backup ContactEric Albrecht, MD
Outcome results
None listed