postbariatric abdominoplasty
Conditions
Interventions
Trade Name: Ropivacain Fresenius Kabi 7.5 mg/ml injeksjonsvæske, oppløsning
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ROPIVACAINE
Sponsors
Avdeling for Anestesi, Intensiv og Operasjon Bærum Sykehus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • American Society of Anesthesiologists Physical Classification Status (ASA) I-II • Age 18 to 64 • Weight above or equal to 60 kg • Scheduled for post-bariatric surgery with standard full abdominoplasty performed by Dr Frøyen • Patient is expected able to cooperate during the treatment and follow up. Signed informed consent obtained and documented according to ICH GCP, and national/local regulations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • a history of anaphylactic shock • cardiovascular disease other than hypertension and/or hyperlipidemia • known allergy to ropivacaine or morphine • a history of chronic pain • psychiatric comorbidity • scheduled pain medication or neuroleptic drugs • coagulation disorders or treatment with platelet inhibitors • treatment with class III antiarrhytmics, sertindole, ziprasidone, amisulpride, citalopram, escitalopram, ceritinib, hydroxizine, fluvoxamine • any medical contraindication to the study intervention by the attending anaesthetist or surgeon (to be specified in screening form).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the preoperative analgesic effect of a preoperative quadratus lumborum block using 0.375% ropivacaine with that of placebo.;Secondary Objective: Secondary objectives are to observe patient satisfaction, and other practical aspects of the intervention in relation to the postoperative period.;Primary end point(s): • Postoperative opioid consumption, opioids other than intravenous morphine will be converted to equianalgesic doses of intravenous morphine according to standard tables;Timepoint(s) of evaluation of this end point: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The average pain defined as numerical rating scale (NRS) area under curve (AUC) divided by the time spent at the postoperative ward. • Time to first opioid dose • Number of re-operations due to suspected bleeding • Duration of surgery • Total amount of local anesthetics • Side effects and complications • Patient satisfaction • Time spent that the postoperative ward • The effect of the QL block as evaluated in a linear mixed effects model where NRS equals opioid consumption plus QL block plus sex. ; Timepoint(s) of evaluation of this end point: Respectively; -Time of discharge from postoperative ward -time of first opioid dose -time of reoperation(s) -in the postoperative ward -in the postoperative ward -upon discharge -upon discharge from the postoperative ward -at 24 hours | — |
Countries
Norway
Contacts
Public ContactThor Wilhelm Bjelland
Avdeling for Anestesi, Intensiv og Operasjon Bærum Sykehus
Outcome results
None listed