This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
158
Dexmedetomidine+Lidocaine
Institut Curie Paris
Paris, France
RECRUITINGInstitut Curie Saint-Cloud
Saint-Cloud, France
RECRUITINGGustave Roussy, Cancer Campus, Grand Paris
Villejuif, France
RECRUITINGcomparison of Morphine consumption in the two groups
Time frame: during the first 48 hours postoperatively
Assessment of vasopressor requirement and total intraoperative filling volume
Time frame: end of surgery
Assessment of the state of consciousness on arrival in the PACU
Time frame: on arrival in the PACU
Assessment of the incidence of PONV in the PACU, at D0, D1 and D2
Time frame: in the PACU, at D0, D1 and D2
Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2
Time frame: in the PACU, at D0, D1 and D2
Dose of morphine given in titration in the PACU (mg)
Time frame: in the PACU
Number of boluses demand on PCA during the first 48 hours postoperatively
Time frame: the first 48 hours postoperatively
DN3 score (Neuropathic Pain 3) on D2, D4, M1, M3 and M6
Time frame: on D2, D4, M1, M3 and M6
Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D)
Time frame: at discharge
Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate
Time frame: at discharge
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Pain management satisfaction scores (score from 0 to 10) at discharge
Time frame: at discharge
Collection of serious adverse events between D0 (date of surgery) and D30
Time frame: between D0 (date of surgery) and D30
Dose of intraoperative rescue remifentanil in the OFA group (mcg)
Time frame: at discharge
Morphine consumption during the first 48 hours post-operatively (mg) in each breast reconstruction subgroup (immediate and secondary);
Time frame: the first 48 hours postoperatively