The analgesic effects of continuous paravertebral infusion of two analgesic mixtures after Video-Assisted Thoracoscopic Surgery (VATS).
Conditions
Interventions
Trade Name: Chirocaine
Pharmaceutical Form: Infusion
Trade Name: Sufenta
Pharmaceutical Form: Infusion
Trade Name: adrenalin mylan
Pharmaceutical Form: Infusion
Sponsors
Institution for Clinical Science, Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 20 to 75 years • ASA (American Society of Anesthesiologists) Physical Status Class 2-3 • Informed consent 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: • Allergy to local anaesthetic • Pronounced hepatic disease • Psychiatric disease or any psychoactive medication • Cognitive disturbance and/or inability to understand written and/or oral instructions • History of chronic pain or chronic pain medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Cumulative 8-hourly NRS after 72 hours. Postoperative NRS every 8 hours for 72 hours. Postoperative NRS in ambulation twice daily for 72 hours. Postoperative recovery according to PQRS at 72 hours, 1 week and 3 months compared to preoperative values. Time until able to perform activities of daily living. Time to eat and drink. Time to walk unaided. Time to GI-function. Day of discharge and discharge time Pre- and postoperative spirometry Plasma levels of stress markers 1, 12 and 36 hours postoperatively compared to preoperative values;Primary end point(s): Cumulated intravenous PCA morphine consumption at 72 hours.;Timepoint(s) of evaluation of this end point: Evaluation of rescue analgesic requirement at 72 hours.;Main Objective: To test the hypothesis that the addition of sufentanil and epinephrine to levobupivacaine in continuous paravertebral block will increase its analgesic potency, resulting in better pain relief and enhanced recovery after Video-Assisted Thoracoscopic Surgery despite the lower total levobupivacaine dose administered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Cumulated NRS score every 8 hours at 72 hours • PQRS score at 72 hours, 1 week and 3 months • NRS at rest at all time points • Morphine consumption at all time points • Cumulated NRS in ambulation twice daily • NRS in ambulation twice daily • Incidence of nausea and/or vomiting at any time during 72 hours • Incidence of sedation at any time during 72 hours • Incidence of pruritis at any time during 72 hours • Spirometry pre- and postoperatively • Plasma levels of stress markers 1, 12 and 36 hours postoperatively compared to preoperative values;Timepoint(s) of evaluation of this end point: • NRS scoring at 8-hour intervals for 72 hours • NRS scoring in ambulation twice daily for 72 hours • Incidence of sedation, nausea or pruritis during 72 hours of the study • PQRS assessment 1- 14 days preoperatively, in the recovery room at 40 minutes postoperatively; 72 hours, 1 week, and 3 months after surgery • Spirometry preoperatively and at day 1 postoperatively | — |
Countries
Sweden
Contacts
Public ContactMark Larsson
Department of Thoracic Surgery, Karolinska
Outcome results
None listed