Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Cesarean Section; Postoperative Nausea and Vomiting; Pain, Postoperative

Treatments: Drug: Ropivacaine; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00891540

H-C-2009-019

Details and patient eligibility

About

The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section.

The hypothesis is that systemic local infiltration will reduce pain and postoperative opioid consumption.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• eligible for elective caesarean section
• able to speak and understand Danish
• able to give informed consent

Exclusion criteria

• alcohol or medical abuse
• allergies to local anesthetics
• age < 18 years
• intolerance to opioids

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Local infiltration with Ropivacaine

Treatment:

Drug: Ropivacaine

Drug: Ropivacaine

2

Active Comparator group

Description:

Local infiltration with Ropivacaine

Treatment:

Drug: Ropivacaine

Drug: Ropivacaine

3

Placebo Comparator group

Description:

Local infiltration with NaCl

Treatment:

Drug: placebo