Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Ropivakain 0,2 % Versus Placebo Efter Sectio Caesarea: et Prospektivt, Dobbeltblindet, Placebokontrolleret Studie.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00891540

Enrollment

Registered

2009-05-01

Start date

2009-07-31

Completion date

2010-05-31

Last updated

2011-06-23

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

Conditions

Cesarean Section, Pain, Postoperative, Postoperative Nausea and Vomiting

Brief summary

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.

Interventions

DRUGRopivacaine

Ropivacaine 0.5%

DRUGplacebo

Isotonic NaCl

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame
Postoperative pain	24 hours

Secondary

Measure	Time frame
Postoperative nausea and vomiting (PONV)	24 hours

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026