NCT01679392

Brief Summary

In this study we investigate the following properties of the transversus abdominis plane block in healthy volunteers:

  1. 1.Cutaneous analgesic distribution
  2. 2.Muscular affection
  3. 3.Reproducibility

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

August 27, 2012

Last Update Submit

March 19, 2015

Conditions

Anesthesia, Local

Keywords

Transversus abdominis plane blockUltrasound guided nerve block

Outcome Measures

Primary Outcomes (1)

  • Cutaneous analgesic distribution

    Cutaneous analgesic distribution 90 min after transversus abdominis plane block administration

    90 min

Secondary Outcomes (2)

  • Muscular affection of the transversus abdominis plane block

    90 min

  • Reproducibility of the transversus abdominis plane block

    At least 2 days

Study Arms (1)

Ropivacaine

EXPERIMENTAL

Unilateral transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)

Drug: Ropivacaine

Interventions

RopivacaineDRUG

Unilateral, single shot, ultrasound-guided, transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)

Also known as: Naropin
Ropivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Capable
  • American society of anesthesiologists classification 1 or 2
  • Written informed consent

You may not qualify if:

  • Age below 18 years
  • American society of anesthesiologists classification above 2
  • Body weight below 50 kg
  • Body mass index \> 35 kg/m2
  • Previous abdominal surgery
  • Acute or chronic pain
  • Use of pain medication less than 24 h prior to study start
  • Allergy to local anesthetics
  • Pregnancy
  • Breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillerød Hospital

Hillerød, 3400, Denmark

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Kion Bo Støving, MD

    Hillerod Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • Charlotte Rosenstock, MD

    Hillerod Hospital, Denmark

    STUDY DIRECTOR

  • Kai Lange, MD

    Hillerod Hospital, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 27, 2012

First Posted

September 6, 2012

Study Start

August 1, 2012

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations

DK(1)