Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study

Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo VED Vaginal Hysterektomi: ET Prospektivt Randomiseret, Dobbeltblind ET, Placebo-kontrolleret Studie

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00768456

Enrollment

Registered

2008-10-08

Start date

2008-10-31

Completion date

2010-12-31

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

Pain, Postoperative, Postoperative Nausea and Vomiting

Brief summary

The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % vs. Placebo in patients undergoing vaginal hysterectomy. The hypothesis is that systematic local infiltration will reduce postoperative pain and postoperative opioid consumption.

Interventions

DRUGRopivacaine 0.5 %

Local Infiltration with Ropivacaine 0.5 %

DRUGIsotonic NaCl

Local Infiltration with 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 No maximum

Healthy volunteers

Inclusion criteria

* eligible for elective vaginal hysterectomy * able to speak and understand Danish * able to give informed consent

Exclusion criteria

* alcohol or medical abuse * allergies to local anesthetics * age \< 18 yrs. * intolerance to opioids

Design outcomes

Primary

Measure	Time frame
Postoperative pain	32 h

Secondary

Measure	Time frame
PONV	32 h

Countries

Denmark

Outcome results

None listed

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