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

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Vaginal Prolapse

Treatments: Drug: Ropivacaine; Drug: Isotonic NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT00769054

H-C-2008-035

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Local Infiltration with Ropivacaine

Treatment:

Drug: Ropivacaine

2

Placebo Comparator group

Description:

Local Infiltration with Placebo

Treatment:

Drug: Isotonic NaCl