Anesthesia, LocalNCT01679392

A Study Investigating Properties of the Transversus Abdominis Plane Block

A study testing Ropivacaine in people with Anesthesia, Local, run by Hillerod Hospital, Denmark at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

In this study we investigate the following properties of the transversus abdominis plane block in healthy volunteers: 1. Cutaneous analgesic distribution 2. Muscular affection 3. Reproducibility Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Anesthesia, Local
What is being tested?: Ropivacaine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteDenmark
Study dates: Aug 2012to May 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

Use of pain medication less than 24 h prior to study start
Allergy to local anesthetics
Pregnancy
Breastfeeding

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Hillerød Hospital
Hillerød, 3400

Other trials in Denmark

About this study

Official title: Transversus Abdominis Plane Block: A Placebo-controlled Study in Healthy Volunteers

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

Cutaneous analgesic distribution
Muscular affection
Reproducibility

Conditions: Anesthesia, Local
Being tested: Ropivacaine
Keywords: Transversus abdominis plane block, Ultrasound guided nerve block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01679392
Study group	Role	What they receive
Ropivacaine	Experimental	Unilateral transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml) Receives: Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Cutaneous analgesic distribution
Cutaneous analgesic distribution 90 min after transversus abdominis plane block administration
Measured: 90 min

Secondary outcomes (2)

Muscular affection of the transversus abdominis plane block
Abdominal wall muscle affection of the transversus abdominal plane block measured by ultrasonography under standardized conditions
Measured: 90 min
Reproducibility of the transversus abdominis plane block
Reproducibility of the transversus abdominis plane block with respect to:
1. Cutaneous analgesic distribution
2. Abdominal wall muscle affection measured in the same individual separated by at least 2 days
Measured: At least 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012May 2013

First posted6 Sep 2012 (estimated)
Study startAug 2012
Primary completionMar 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01679392
Sponsor's protocol ID: H-1-2011-030
Other IDs: 2011-004719-22
Status last verified: Mar 2015
First submitted: 27 Aug 2012
Last updated: 20 Mar 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
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Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis

All Anesthesia, Local trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transversus Abdominis Plane Block: A Placebo-controlled Study in Healthy Volunteers
ClinicalTrials.gov ID: NCT01679392
Acronym / sponsor ID: H-1-2011-030
Conditions: Anesthesia, Local
Keywords: Transversus abdominis plane block, Ultrasound guided nerve block
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Hillerod Hospital, DenmarkUniversity, hospital or other
Study start: Aug 2012
Primary completion: Mar 2013 (actual)
Study completion: May 2013 (actual)
First posted: 6 Sep 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Cutaneous analgesic distribution
Muscular affection
Reproducibility

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 1

Arm	Type	Receives
Ropivacaine	Experimental	Drug: RopivacaineUnilateral transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RopivacaineAlso: NaropinUnilateral, single shot, ultrasound-guided, transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)	Drug	Ropivacaine

Primary outcome

Cutaneous analgesic distribution
Time frame: 90 min
Cutaneous analgesic distribution 90 min after transversus abdominis plane block administration

2 secondary outcomes

Muscular affection of the transversus abdominis plane block
Time frame: 90 min
Reproducibility of the transversus abdominis plane block
Time frame: At least 2 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.

Related trials for Anesthesia, Local

RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kion Bo Støving, MD principal investigator

Hillerod Hospital, Denmark

Charlotte Rosenstock, MD study director

Hillerod Hospital, Denmark

Kai Lange, MD study director

Hillerod Hospital, Denmark

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine in people with Anesthesia, Local, run by Hillerod Hospital, Denmark at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cutaneous analgesic distribution (time frame: 90 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01679392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.