Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study

Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00769054

Enrollment

Registered

2008-10-08

Start date

2008-10-31

Completion date

2009-10-31

Last updated

2010-07-09

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

Conditions

Vaginal Prolapse

Keywords

Postoperative pain, PONV

Brief summary

The purpose of this study is to compare systematic local infiltration with ropivacaine or placebo in patients undergoing repair of posterior vaginal wall prolapse. The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment.

Interventions

DRUGRopivacaine

Local Infiltration Analgesia with 1 % Ropivacaine

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 repair of posterior vaginal wall prolapse * 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 during rest, coughing and ambulation	½, 1, 2, 4, 8, 12 and 24 h postoperatively

Secondary

Measure	Time frame
Postoperative Nausea and Vomitus	½, 1, 2, 4, 8, 12 and 24 h postoperatively

Countries

Denmark

Outcome results

None listed

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