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CompletedNCT02415088Updated Apr 5, 2016

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

An interventional study of Interscalene block and Selective shoulder block in Pain, Postoperative, sponsored by Stessel Björn. Completed at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-04-05.

Sponsored by Stessel Björn · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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).

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.

02

Conditions studied

  • Pain, Postoperative

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Keywords

  • Nerve block
03

In context

Pain, Postoperative

5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's enrollment of 100 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

This is the only study on the registry with Stessel Björn as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Interscalene block

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

    Procedure: Interscalene block

  • Active comparator
    Selective shoulder block

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

    Procedure: Selective shoulder block

Interventions

  • ProcedureInterscalene block

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

  • ProcedureSelective shoulder block

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

06

What researchers measure

Primary outcomes

  1. Pain Score as measured by Numeric Rating Scale

    Time frame: 24hours

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

    Time frame: 24hours

Secondary outcomes

  1. Subjective feeling of dyspnea as measured by a numeric rating scale

    Time frame: 24hours

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

    Time frame: 24hours

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

    Time frame: 24hours

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

    Time frame: 48 hours

07

Study locations

1 site
  • Jessaziekenhuis Hasselt
    Hasselt, Limburg 3500, Belgium
08

References and documents

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 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2015, a primary completion of Feb 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2015
First posted
Apr 14, 2015
Start
Apr 2015
Primary completionActual
Feb 2016
CompletionActual
Feb 2016
Last update
Apr 5, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02415088
Lead sponsor
Stessel Björn
Responsible party
Stessel Björn (MD, Jessa Hospital) — Sponsor-investigator
First posted
Apr 14, 2015
Start date
Apr 2015
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Apr 5, 2016

Study contacts

Dirk Schoorens, MD
principal investigator · Jessa Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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