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CompletedNCT00891540Updated Jun 23, 2011

Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

A Phase 4 interventional study of Ropivacaine and Ropivacaine in Pain, Postoperative, Postoperative Nausea and Vomiting and Cesarean Section, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2011-06-23.

Sponsored by Hvidovre University Hospital · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Pain, Postoperative
  • Postoperative Nausea and Vomiting
  • Cesarean Section
03

In context

Vomiting

1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.

This study's planned enrollment of 90 is below the median of 107 across 935 interventional studies indexed under Vomiting.

Browse Vomiting studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • alcohol or medical abuse
  • allergies to local anesthetics
  • age \< 18 years
  • intolerance to opioids
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    1

    Local infiltration with Ropivacaine

    Drug: Ropivacaine

  • Active comparator
    2

    Local infiltration with Ropivacaine

    Drug: Ropivacaine

  • Placebo comparator
    3

    Local infiltration with NaCl

    Drug: placebo

Interventions

  • DrugRopivacaine

    Ropivacaine 0.5%

  • DrugRopivacaine

    Ropivacaine 0.2%

  • Drugplacebo

    Isotonic NaCl

06

What researchers measure

Primary outcomes

  1. Postoperative pain

    Time frame: 24 hours

Secondary outcomes

  1. Postoperative nausea and vomiting (PONV)

    Time frame: 24 hours

07

Study locations

1 site
  • Hvidovre University Hospital
    Copenhagen, Hvidovre 2650, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00891540
Lead sponsor
Hvidovre University Hospital
First posted
May 1, 2009
Start date
Jul 2009
Primary completion
May 2010
Completion
May 2010
Last update
Jun 23, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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