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Completed

NCT Number: NCT02415088

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

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessaziekenhuis Hasselt

Hasselt, Limburg, 3500, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

interscalene block

Procedure

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

Selective shoulder block

Procedure

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

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

Sponsors and collaborators

Lead sponsor

Stessel Björn

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 14, 2015
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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