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Pain, PostoperativeNCT02415088

Ultrasound-guided Selective Shoulder Block Versus Ultrasound-guided Interscalene Brachial Plexus Block, an RCT

A study testing Interscalene block and Selective shoulder block in people with Pain, Postoperative, run by Stessel Björn at 1 site in Belgium.

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

This is a randomised, observer-blinded trial to compare selective shoulder block with interscalene block. Both blocks will be placed using an ultra-sound guided technique. Primary outcome measures will be postoperative pain scores and use of rescue opioids. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pain, Postoperative
What is being tested?
Interscalene block and Selective shoulder block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteBelgium
Study dates
Apr 2015to Feb 2016
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • elective arthroscopic shoulder surgery
  • elective hospital admission for one night
  • age > 18 years and < 75 years
  • American Society of Anesthesiologists (ASA) physical status classification 1, 2 of 3.

Who cannot join

  • pregnancy
  • severe obesity ( BMI > 35)
  • severe COPD (Gold≥ 3) or restrictive (FEV1 < 50%) lungdisease
  • coagulation disorders
  • diabetes mellitus
  • previous injury or surgery of the involved shoulder
Show all 14Show fewer
  • pre-existing neuropathy or myopathy of the involved arm
  • allergy or contra-indication for the medication used in the study
  • preoperative use of opioids
  • infection at the puncture site
  • inability to understand or speak Dutch
  • inability to understand the PCIA system
  • inability to understand the NRS pain score system
  • refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Jessaziekenhuis Hasselt

    Hasselt, Limburg, 3500

Other trials in Belgium

About this study

Official title: Treatment of Postoperative Pain After Shoulder Surgery. Ultrasound-guided Block of the Axillary and Suprascapular Nerves (Selective Shoulder Block) Versus Ultrasound-guided Interscalene Brachial Plexus Block: An Observer-blinded RCT

This is a randomised, observer-blinded trial to compare selective shoulder block with interscalene block. Both blocks will be placed using an ultra-sound guided technique.

Primary outcome measures will be postoperative pain scores and use of rescue opioids. Secondary outcome measures will be pre- and postoperative occurence of motor deficit of the arm and dyspnea, quality of sleep in the first night after surgery as measured by a numeric rating scale and overall satisfaction with pain therapy as measured by the International Pain Outcomes questionnaire and an NRS-score (0 = not satisfied at all and 10 = very satisfied).

Read more

Primary and secondary outcome measures will be assessed during the first 24hours after surgery (assessment in the postanesthetic care unit (PACU) directly after admission and before discharge and in the surgical ward at 4, 8 and 24 hours after surgery).

Overall satisfaction with pain therapy will be assessed 48hours after surgery.

An interscalene block is a block of the plexus brachialis in the interscelene triangle (by injecting a local anesthetic around the nerve plexus).

A selective shoulder block is a block of the suprascapular and axillary nerves (by injecting a local anesthetic around these nerves).

Read the detailed description

This is a randomised, observer-blinded trial to compare selective shoulder block with interscalene block.

The goal of this study is to compare ultrasound-guided selective shoulder block (regional anesthesia of the suprascapular and axillary nerves) with ultrasound-guided interscalene block after arthroscopic shoulder surgery.

More specific, this study is designed to compare postoperative pain scores, use of opioids, pre- and postoperative occurence of motor deficit of the arm and dyspnea, quality of sleep in the first night after surgery as measured by a numeric rating scale and overall satisfaction as measured by the International Pain Outcomes questionnaire and an NRS-score (0 = not satisfied at all and 10 = very satisfied).

Primary and secondary outcome measures will be assessed during the first 24hours after surgery (assessment in the postanesthetic care unit (PACU) directly after admission and before discharge and in the surgical ward at 4, 8 and 24 hours after surgery).

Overall satisfaction with pain therapy will be assessed 48hours after surgery.

Continuous interscalene brachial plexus block is considered to be the standard treatment for postoperative pain after shoulder surgery. With interscalene block a local anesthetic is injected around the nerve plexus supplying motor and sensory innervation to the upper limb. Disadvantages are an extensive motor and sensory block of the upper limb and paresis of the diaphragm sometimes provoking dyspnea.

Since 2007 newer techniques are described, for example selective block of the suprascapular nerve and the axillary nerve. These two nerves supply most of the shoulder joint with motor and sensory innervation, but have no function in the distal part of the upper limb. The risk of loss of innervation to the diaphragm is avoided with this selective shoulder block. Hence, possible breathing disorders are avoided. Previous studies have concluded that the selective shoulder block is a safe technique and is effective to reduce postoperative pain after arthroscopic shoulder surgery. Moreover, studies also suggest that selective shoulder block has a longer duration, less fluctutations in pain score and less rebound pain after fading of the regional anesthesia.

With this study the investigators want to compare the effect of this newer technique with the single shot interscalene plexus block. Therefore the investigators will allocate the patients to two groups for comparison. One group will receive interscalene plexus block and the other group will receive a selective shoulder block. The used local anesthetic will be the same in both groups, that is ropivacaine 0,75% with a total volume of 20 ml.

Both blocks will be placed using an ultra-sound guided technique. In previous studies a blind technique, based on anatomical reference points or nerve stimulation, has been used to place the selective shoulder block. As both blocks will be placed with an ultrasound-guided technique, the anesthesiologist will have a direct view of the location of the needle. With this technique there is less risk for accidental intravascular injection or nerve injury. Also there is greater probability of success and faster implementation of the block.

Indepent of the technique used, the pain that the patient may experience will be reduced to a minimum. Therefore the patient wlll be supplied with a PCIA system (patient controlled intravenous analgesia), next to the standard pain relievers (paracetamol, anti-inflammatory medication). This PCIA system is a pump system with piritramide (Dipidolor®, an opioid) connected with the infusion line. The system is set up in a way that, within certain limits, the patient can decide for him/herself when pain treatment is provided.

This is a monocentric, prospective, randomised and observer-blinded study. Patients included will be randomised in two groups. One group will receive the ultrasound-guided single shot interscalene block, the other group will receive the ultrasound-guided selective shoulder block (axillary nerve and suprascapular nerve). The patient is not strictly blinded as there are two injections needed for the selective shoulder block, compared to only one injection for the interscalene block. The data collector (per- and postoperative) will be blinded, as he will not be informed about which block is performed. This in order to avoid bias.

Being tested
Interscalene block, Selective shoulder block
Keywords
Nerve block
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Interscalene blockProcedure or surgery

    block of the plexus brachialis in the interscalene region with local anaesthetics

  • Selective shoulder blockProcedure or surgery

    selective block of the suprascapular nerve and the axillary nerve with local anaesthetics

Study groups in NCT02415088
Study groupRoleWhat they receive
Interscalene blockActive comparatorblock of the plexus brachialis in the interscalene region with local anaesthetics
Receives: Procedure: Interscalene block
Selective shoulder blockActive comparatorselective block of the suprascapular nerve and the axillary nerve with local anaesthetics
Receives: Procedure: Selective shoulder block

What is being measured

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

  1. Pain Score as measured by Numeric Rating Scale

    Measured: 24hours

  2. Use of piritramide as documented by the PCIA (patient controlled intravenous analgesia) system

    Measured: 24hours

Secondary outcomes (4)
  1. Subjective feeling of dyspnea as measured by a numeric rating scale

    Measured: 24hours

  2. Motor deficit after nerve block as measured by Medical Research Council scale

    Measured: 24hours

  3. Quality of sleep in the first night after surgery as measured by a numeric rating scale

    Measured: 24hours

  4. Overall satisfaction as measured by the International Pain Outcomes questionnaire

    Measured: 48 hours

Timeline

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

  1. First posted14 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

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
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02415088
Sponsor's protocol ID
15.26/anesth15.01
Status last verified
Apr 2016
First submitted
8 Mar 2015
Last updated
5 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • Neuts A, Stessel B, Wouters PF, Dierickx C, Cools W, Ory JP, Dubois J, Jamaer L, Arijs I, Schoorens D. Selective Suprascapular and Axillary Nerve Block Versus Interscalene Plexus Block for Pain Control After Arthroscopic Shoulder Surgery: A Noninferiority Randomized Parallel-Controlled Clinical Trial. Reg Anesth Pain Med. 2018 Oct;43(7):738-744. doi: 10.1097/AAP.0000000000000777.

    PubMed 29659438

Questions about this trial

What is this clinical trial studying?

A study testing Interscalene block and Selective shoulder block in people with Pain, Postoperative, run by Stessel Björn at 1 site in Belgium.

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 4 inclusion and 14 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 5 Apr 2016. 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 Belgium. 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?

Pain Score as measured by Numeric Rating Scale (time frame: 24hours). The study lists 2 primary outcomes in all. 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 NCT02415088, which also lists 1 linked publication.

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 5 Apr 2016.

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