NCT00769054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

July 9, 2010

Status Verified

October 1, 2008

Enrollment Period

1 year

First QC Date

October 7, 2008

Last Update Submit

July 8, 2010

Conditions

Vaginal Prolapse

Keywords

Postoperative painPONV

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain during rest, coughing and ambulation

    ½, 1, 2, 4, 8, 12 and 24 h postoperatively

Secondary Outcomes (1)

  • Postoperative Nausea and Vomitus

    ½, 1, 2, 4, 8, 12 and 24 h postoperatively

Study Arms (2)

1

ACTIVE COMPARATOR

Local Infiltration with Ropivacaine

Drug: Ropivacaine

2

PLACEBO COMPARATOR

Local Infiltration with Placebo

Drug: Isotonic NaCl

Interventions

RopivacaineDRUG

Local Infiltration Analgesia with 1 % Ropivacaine

1
Isotonic NaClDRUG

Local Infiltration with NaCl

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • eligible for elective repair of posterior vaginal wall prolapse
  • able to speak and understand Danish
  • able to give informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Uterine ProlapsePain, PostoperativePostoperative Nausea and Vomiting

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Billy B Kristensen, MD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2008

First Posted

October 8, 2008

Study Start

October 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

July 9, 2010

Record last verified: 2008-10

Locations

DK(1)