SUPplementary REgional anesthesia in MAmma surgery (SUPREMA trial).

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22294

Enrollment

150

Registered

2009-02-25

Start date

2007-10-07

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Mamma surgery Breast cancer Borst operatie Borstkanker

Interventions

Regional infiltration anesthesia of the nerve branches of the mamma subjected to surgery with ropivacaine 0,75% (maximum volume 0,47 ml/kg) or placebo (a comparable volume of NaCl 0,9%). The regional

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women; 2. One-sided breast conserving surgery with or without sentinel node biopsy; 3. Age 18-80 yr.

Exclusion criteria

Exclusion criteria: 1. Known allergy to amide type local anesthetics; 2. Severe liver failure; 3. Weight >120 kg; 4. Double-sided mamma surgery; 5. Infections in the infiltration region; 6. Breast conserving surgery combined with plastic surgery; 7. Pregnancy or lactation; 8. Use of opiates; 9. Use of anti-emetics.

Design outcomes

Primary

Measure	Time frame
Postoperative vomiting in the first 24 hours.	—

Secondary

Measure	Time frame
1. Postoperative nausea at entrance at entry in the recovery room and 4,8 and 24 hours after surgery (VAS score 0-10 cm); 2. Postoperative pain at entrance at entry in the recovery room and 4,8 and 24 hours after surgery (VAS score 0-10 cm); 3. Need for postoperative opiates (frequency and total dose in first 24 hours); 4. Need for postoperative anti-emetics (frequency and total dose in first 24 hours).	—

Measure

Time frame

1. Postoperative nausea at entrance at entry in the recovery room and 4,8 and 24 hours after surgery (VAS score 0-10 cm); 2. Postoperative pain at entrance at entry in the recovery room and 4,8 and 24 hours after surgery (VAS score 0-10 cm); 3. Need for postoperative opiates (frequency and total dose in first 24 hours); 4. Need for postoperative anti-emetics (frequency and total dose in first 24 hours).

—

Contacts

Public ContactL.P. Tan

Apotheek Reinier de Graaf Groep Delft Postbus 5011

vtan@rdgg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)