Analgesia
Conditions
Brief summary
Unilateral mastectomy is associated with moderate to severe postoperative pain. A new regional anaesthetic technique has been recently described, call the PEC block. This technique consists of injecting local anaesthetic between different muscles of the chest in order to relieve postoperative pain. The investigators aim to verify that this technique has a clinical relevant postoperative analgesic effect. For that purpose, the investigators will randomise 50 patients scheduled to undergo unilateral mastectomy into two groups: one group will receive a PEC block after the induction of the general anaesthesia under ultrasound guidance, while the other group will not have this regional procedure.
Interventions
PROCEDUREPEC block + General anaesthesia
Patients will receive an ultrasound-guided PEC block after the induction of general anaesthesia.
PROCEDUREGeneral anaesthesia
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA physical status I-III * Age ≥ 18 * Patients undergoing unilateral mastectomy
Exclusion criteria
* Contraindications to regional block * Pregnancy * Inability to give informed consent * History of alcohol or drug dependence/abuse * History of long term opioid intake or chronic pain disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intravenous morphine consumption during the first 24 postoperative hours (mg) | Postoperative day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intravenous morphine consumption on postoperative day 2 (mg) | Postoperative day 2 | — |
| Intravenous morphine consumption in phase 1 recovery (mg) | 2 postoperative hours | — |
| Pain scores at rest in phase 1 recovery (visual analogue scale, 0 - 10) | 2 postoperative hours | (visual analogue scale, 0 - 10) |
| Pain scores at rest on postoperative day 1 (visual analogue scale, 0 - 10) | Postoperative day 1 | Visual analogue scale, 0 - 10) |
| Pain scores at rest on postoperative day 2 (visual analogue scale, 0 - 10) | Postoperative day 2 | Visual analogue scale, 0 - 10) |
| Postoperative nausea and vomiting (yes/no) | Postoperative day 1 | — |
| Pruritus (yes/no) | Postoperative day 1 | — |
Countries
Switzerland
Outcome results
None listed