NCT01504386

Brief Summary

The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane (TAP) block as a part of a multimodal postoperative pain management after robot-assisted laparoscopic hysterecomy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 22, 2013

Status Verified

August 1, 2013

Enrollment Period

1.2 years

First QC Date

December 30, 2011

Last Update Submit

August 21, 2013

Conditions

Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Total opioid consumption

    Opioid consumption via PCA-pump

    0-24 hours

Secondary Outcomes (2)

  • Pain during rest and cough

    1,2,4,8,18 and 24 hours

  • Postoperative nausea and vomiting

    1,2,4,8,18 and 24 hours

Study Arms (2)

TAP block

EXPERIMENTAL

TAP block with ropivacaine

Procedure: TAP block

Placebo TAP block

PLACEBO COMPARATOR

Sham block with saline

Procedure: Placebo TAP block

Interventions

TAP blockPROCEDURE

Bilateral UL-guided TAP block with 20 ml of ropivacaine 0.5 %

Also known as: Naropin 0.5%
TAP block
Placebo TAP blockPROCEDURE

Bilateral placement of 20 ml of saline 0.9 % in the transversus abdominis plane

Also known as: Saline 0.9%
Placebo TAP block

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80
  • BMI 17-40
  • Written consent
  • Can cooperate

You may not qualify if:

  • Drug and alcohol abuse
  • Consumption of opioids
  • Drug allergy
  • Infection at insertion point of needle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Univerity Hospital, Department of Anaesthesia

Herlev, 2730, Denmark

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Henrik Torup, MD

    Herlev University Hospital, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2011

First Posted

January 5, 2012

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

July 1, 2013

Last Updated

August 22, 2013

Record last verified: 2013-08

Locations

DK(1)