The influence of supplementary regional infiltration anesthesia with ropivacaine on postoperative pain, nausea and vomiting in patients undergoing mamma surgery under general anesthesia

The influence of supplementary regional infiltration anesthesia with ropivacaine on postoperative pain, nausea and vomiting in patients undergoing mamma surgery under general anesthesia - SUPplementary REgional anesthesia in MAmma surgery (SUPREMA trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35556

Enrollment

150

Registered

2008-06-09

Start date

2008-10-10

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nausea and vomiting pain

Interventions

Regional infiltration anesthesia of the ipsilateral breast with ropivacaine 0,75% (maximum volume 0,47 ml/kg) or placebo (a comparable volume of NaCl 0,9%). The regional infiltration consists of deep

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: women one-sided breast conserving surgery with or without sentinel node biopsy age 18-80 yr

Exclusion criteria

Exclusion criteria: known allergy to amide type local anesthetics severe liver failure weight >120 kg double-sided breast surgery infections in the infiltration region breast conserving surgery combined with plastic surgery pregnancy/lactation use of opiates use of anti-emetics

Design outcomes

Primary

Measure	Time frame
postoperative vomiting in the first 24 hours	—

Secondary

Measure	Time frame
Postoperative nausea 4,8 and 24 hours after start of surgery (VAS score 0-10) Postoperative pain 4,8 and 24 hours after start of surgery (VAS score 0-10) Need for postoperative opiates (frequency and total dose in first 24 hours) Need for anti-emetics (frequency and total dose in first 24 hours)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)