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

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Nausea and Vomiting; Pain, Postoperative

Treatments: Drug: Isotonic NaCl; Drug: Ropivacaine 0.5 %

Study type: Interventional

Funder types: Other

Identifiers

NCT00768456

H-C-2008-030

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

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 0.5 %

2

Placebo Comparator group

Description:

Local infiltration with Placebo (NaCl)

Treatment:

Drug: Isotonic NaCl