Fracture at Wrist and/or Hand LevelNCT01993290

USG Brachial Plexus Block for Upper Extremity Surgery

A study testing Ropivacaine in people with Fracture at Wrist and/or Hand Level and Rupture of Tendon of Wrist and Hand, run by Jens Borglum Neimann at 1 site in Denmark.

Completed

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

Official record

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Trial summary

Ultrasound-guided (USG) brachial plexus (BP) block efficacy at the Supraclavicular (SCL), Lateral- Infraclavicular (LIC) and Axillary (AX) level: Randomized, observer-blinded study of the single-penetration multiple-injection-technique. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Fracture at Wrist and/or Hand Level, Rupture of Tendon of Wrist and Hand, Injuries to the Wrist, Hand and Fingers (S60-S69)
What is being tested?: Ropivacaine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteDenmark
Study dates: Apr 2013to Jun 2015
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Age above 18 years
American Society of Anaesthesiology class 1-3
Patients undergoing upper extremity surgery

Who cannot join

Inability to cooperate
Inability to understand and talk danish
Allergic to ropivacaine
Infection at site of surgery
Neurological dysfunction at site of surgery
Severe coagulopathy

Show all 10Show fewer

Drug and alcohol abuse
Patients, who can not get a nerve block due to technical difficulty
Pregnancy or nursing
Body mass index >35

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Department of anaesthesiology, Bispebjerg Hospital
Copenhagen, 2400

Other trials in Denmark

About this study

Official title: Ultrasound-guided Brachial Plexus Block With the Single-penetration Multiple-injection-technique for Upper Extremity Surgery

Read the detailed description

The investigators will compare the BP block efficacy (for surgical anaesthesia) with the USG single-penetration multiple-injection-technique at the SCL, LIC and AX level for upper-extremity surgery (elbow, forearm, wrist, hand). The investigators want to investigate whether the single-penetration multiple-injection-technique would provide for safe surgical anaesthesia with lower volumes of local anaesthetics than has previously been described in a comparative study at the three different levels.

120 patients will prospectively be randomized to an USG BP block administered as a single-penetration multiple-injection-technique at one of three different levels: (1) SCL (2) LIC (3) AX. Ropivacaine 0.75% (20 mL) will be used for all blocks prior to surgery.

Conditions: Fracture at Wrist and/or Hand Level, Rupture of Tendon of Wrist and Hand, Injuries to the Wrist, Hand and Fingers (S60-S69), Ganglion Cysts, Carpal Tunnel Syndrome
Being tested: Ropivacaine
Medical subject headings: Ganglion Cysts, Carpal Tunnel Syndrome

What participants receive

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

RopivacaineDrug
Also called Naropin
20 ml in total of 0,75% Ropivacaine is administered to each patient in all three arms.

Study groups in NCT01993290
Study group	Role	What they receive
USG Supraclavicular block	Active comparator	20 ml of ropivacaine 0,75% is administered to brachial plexus at supraclavicular level. Receives: Drug: Ropivacaine
Lateral infraclavicular block	Active comparator	20 ml of ropivacaine 0,75 % is administered to brachialis plexus at lateral infraclavicular level Receives: Drug: Ropivacaine
USG Axillaris block	Active comparator	20 ml of ropivacaine 0,75% is administered to plexus brachialis at axillaris level Receives: Drug: Ropivacaine

What is being measured

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

Blockade performance time (seconds)
Measured: Time (seconds) from the time the ultrasound transducer is placed on the skin and until the needle is taken out of the body.

Secondary outcomes (4)

Onset time of blockade (minutes)
Measured: Time from block completion to complete sensory and motor block is accomplished.
Number of needle passes
Measured: Number of times the direction of the needle changes while performing the block
Patient reported pain related to needle passes (Scale 0-2)
0= no pain
1. middle
2. sever pain
Measured: Pain related to block performance reported by the patient right after block completion
Duration of time of block postoperatively (hours)
Measured: Patient reported the time off ending sensory and motory block

Timeline

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

Apr 2013Jun 2015

First posted25 Nov 2013 (estimated)
Study startApr 2013
Primary completionOct 2014
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Fracture at Wrist and/or Hand LevelStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01993290
Sponsor's protocol ID: BBH-PB
Other IDs: H-2-2012-055
Status last verified: Jul 2015
First submitted: 10 Jun 2013
Last updated: 21 Jul 2015
Results posted: No
Data monitoring committee: Yes

Publications

Koscielniak-Nielsen ZJ, Frederiksen BS, Rasmussen H, Hesselbjerg L. A comparison of ultrasound-guided supraclavicular and infraclavicular blocks for upper extremity surgery. Acta Anaesthesiol Scand. 2009 May;53(5):620-6. doi: 10.1111/j.1399-6576.2009.01909.x.
PubMed 19419356
Mariano ER, Sandhu NS, Loland VJ, Bishop ML, Madison SJ, Abrams RA, Meunier MJ, Ferguson EJ, Ilfeld BM. A randomized comparison of infraclavicular and supraclavicular continuous peripheral nerve blocks for postoperative analgesia. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):26-31. doi: 10.1097/AAP.0b013e318203069b.
PubMed 21455085
Tran DQ, Munoz L, Zaouter C, Russo G, Finlayson RJ. A prospective, randomized comparison between single- and double-injection, ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):420-4. doi: 10.1097/AAP.0b013e3181ae733a.
PubMed 19920418

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasound-guided Brachial Plexus Block With the Single-penetration Multiple-injection-technique for Upper Extremity Surgery
ClinicalTrials.gov ID: NCT01993290
Acronym / sponsor ID: BBH-PB
Conditions: Fracture at Wrist and/or Hand Level, Rupture of Tendon of Wrist and Hand, Injuries to the Wrist, Hand and Fingers (S60-S69), Ganglion Cysts, Carpal Tunnel Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (estimated)
Lead sponsor: Jens Borglum NeimannUniversity, hospital or other
Study start: Apr 2013
Primary completion: Oct 2014 (actual)
Study completion: Jun 2015 (actual)
First posted: 25 Nov 2013 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
USG Supraclavicular block	Active comparator	Drug: Ropivacaine20 ml of ropivacaine 0,75% is administered to brachial plexus at supraclavicular level.
Lateral infraclavicular block	Active comparator	Drug: Ropivacaine20 ml of ropivacaine 0,75 % is administered to brachialis plexus at lateral infraclavicular level
USG Axillaris block	Active comparator	Drug: Ropivacaine20 ml of ropivacaine 0,75% is administered to plexus brachialis at axillaris level

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age above 18 years
American Society of Anaesthesiology class 1-3
Patients undergoing upper extremity surgery

Key exclusion criteria (10 listed)

Inability to cooperate
Inability to understand and talk danish
Allergic to ropivacaine
Infection at site of surgery
Neurological dysfunction at site of 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: Naropin20 ml in total of 0,75% Ropivacaine is administered to each patient in all three arms.	Drug	Lateral infraclavicular block, USG Axillaris block, USG Supraclavicular block

Primary outcome

Blockade performance time (seconds)
Time frame: Time (seconds) from the time the ultrasound transducer is placed on the skin and until the needle is taken out of the body.

4 secondary outcomes

Onset time of blockade (minutes)
Time frame: Time from block completion to complete sensory and motor block is accomplished.
Number of needle passes
Time frame: Number of times the direction of the needle changes while performing the block
Patient reported pain related to needle passes (Scale 0-2)
Time frame: Pain related to block performance reported by the patient right after block completion
Duration of time of block postoperatively (hours)
Time frame: Patient reported the time off ending sensory and motory block

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 21 Jul 2015.
Background: PubMed 19419356Koscielniak-Nielsen ZJ, Frederiksen BS, Rasmussen H, Hesselbjerg L. A comparison of ultrasound-guided supraclavicular and infraclavicular blocks for upper extremity surgery. Acta Anaesthesiol Scand. 2009 May;53(5):620-6. doi: 10.1111/j.1399-6576.2009.01909.x.
Background: PubMed 21455085Mariano ER, Sandhu NS, Loland VJ, Bishop ML, Madison SJ, Abrams RA, Meunier MJ, Ferguson EJ, Ilfeld BM. A randomized comparison of infraclavicular and supraclavicular continuous peripheral nerve blocks for postoperative analgesia. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):26-31. doi: 10.1097/AAP.0b013e318203069b.
Background: PubMed 19920418Tran DQ, Munoz L, Zaouter C, Russo G, Finlayson RJ. A prospective, randomized comparison between single- and double-injection, ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):420-4. doi: 10.1097/AAP.0b013e3181ae733a.

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.

Mojgan Vazin, MD principal investigator

Department of Anaesthesiology, Bispebjerg hospital

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 Fracture at Wrist and/or Hand Level and Rupture of Tendon of Wrist and Hand, run by Jens Borglum Neimann 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 21 Jul 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?

Blockade performance time (seconds) (time frame: Time (seconds) from the time the ultrasound transducer is placed on the skin and until the needle is taken out of the body.). 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 NCT01993290, which also lists 3 linked publications.

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 21 Jul 2015; AzTrials last refreshed its copy on 27 Oct 2026.