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

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ClinicalTrials.gov Identifier: NCT02415088
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Stessel Björn, Jessa Hospital

Brief 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).


Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Interscalene block Procedure: Selective shoulder block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Active Comparator: Interscalene block
block of the plexus brachialis in the interscalene region with local anaesthetics
Procedure: Interscalene block
block of the plexus brachialis in the interscalene region with local anaesthetics

Active Comparator: Selective shoulder block
selective block of the suprascapular nerve and the axillary nerve with local anaesthetics
Procedure: Selective shoulder block
selective block of the suprascapular nerve and the axillary nerve with local anaesthetics




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415088


Locations
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Belgium
Jessaziekenhuis Hasselt
Hasselt, Limburg, Belgium, 3500
Sponsors and Collaborators
Stessel Björn
Investigators
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Principal Investigator: Dirk Schoorens, MD Jessa Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stessel Björn, MD, Jessa Hospital
ClinicalTrials.gov Identifier: NCT02415088    
Other Study ID Numbers: 15.26/anesth15.01
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016
Keywords provided by Stessel Björn, Jessa Hospital:
Nerve block
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations