Opioid Free Anesthesia in Breast Cancer Surgery
Nøkkelord
Abstrakt
Beskrivelse
Breast cancer is one of the most common oncologic diagnosis in women. Surgery is traditionally performed under general anesthesia with opioid‑based analgesia. It is associated with higher incidences of PONV, more severe acute postoperative pain and increased incidences of chronic pain. The possibility of higher risk of metastasis has also been reported.
The purpose of our study is to compare the opioid‑free general anesthesia with the opioid‑based general anesthesia with respect to the primary outcome measures of PONV and secondary outcome measures of pain relief, analgesic requirement , incidence of chronic pain, cancer recurrence and metastasis.
Datoer
| Sist bekreftet: | 04/30/2020 |
| Først sendt: | 05/07/2020 |
| Anslått påmelding sendt: | 05/11/2020 |
| Først lagt ut: | 05/14/2020 |
| Siste oppdatering sendt: | 05/11/2020 |
| Siste oppdatering lagt ut: | 05/14/2020 |
| Faktisk studiestartdato: | 05/31/2020 |
| Anslått primær ferdigstillelsesdato: | 11/30/2020 |
| Anslått sluttdato for studien: | 06/30/2021 |
Tilstand eller sykdom
Intervensjon / behandling
Procedure: nerve block+opioid-free general anesthesia
Drug: nerve block+opioid-free general anesthesia
Procedure: sham bock+opioid general anesthesia
Procedure: sham bock+opioid general anesthesia
Fase
Armgrupper
| Væpne | Intervensjon / behandling |
|---|---|
| Experimental: nerve block+opioid-free general anesthesia Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia | Procedure: nerve block+opioid-free general anesthesia Paravertebral block will be performed at T2,T4 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.4% ropivacaine 20ml at each injection site. |
| Sham Comparator: sham bock+opioid general anesthesia Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia | Procedure: sham bock+opioid general anesthesia Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site. |
Kvalifikasjonskriterier
| Alder Kvalifisert for studier | 20 Years Til 20 Years |
| Kjønn som kan studeres | Female |
| Godtar sunne frivillige | Ja |
| Kriterier | Inclusion Criteria: first diagnosis of histologically confirmed primary breast cancer; undergoing radical mastectomy; patients with I or II staging based on TNM staging system; ASA physical statue I-II; Exclusion Criteria: smoking history, chronic pain and opioid administration history; allergy to local anesthetics or NSAIDs; coagulation disorders; local infection at regional block site; a history of motion sickness, or a previous episode of PONV; unable to comply to study protocol schedule for logistic or other reasons; refusal to participate to the study |
Utfall
Primære utfallstiltak
1. postoperative nausea and vomiting [up to 24 hours after surgery]
Sekundære utfallstiltak
1. health related quality of life [up to 3 months after surgery]
2. chronic pain [up to 3 months after surgery]
3. cancer recurrence and metastasis [up to 12 months after surgery]
4. pain severity [up to 24 hours after surgery]
