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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Interscalene block
Selective shoulder block
Sponsored by
Stessel Björn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Nerve block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jessaziekenhuis Hasselt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Interscalene block

Selective shoulder block

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain Score as measured by Numeric Rating Scale
Use of piritramide as documented by the PCIA (patient controlled intravenous analgesia) system

Secondary Outcome Measures

Subjective feeling of dyspnea as measured by a numeric rating scale
Motor deficit after nerve block as measured by Medical Research Council scale
Quality of sleep in the first night after surgery as measured by a numeric rating scale
Overall satisfaction as measured by the International Pain Outcomes questionnaire

Full Information

First Posted
March 8, 2015
Last Updated
April 2, 2016
Sponsor
Stessel Björn
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1. Study Identification

Unique Protocol Identification Number
NCT02415088
Brief Title
Ultrasound-guided Selective Shoulder Block Versus Ultrasound-guided Interscalene Brachial Plexus Block, an RCT
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stessel Björn

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interscalene block
Arm Type
Active Comparator
Arm Description
block of the plexus brachialis in the interscalene region with local anaesthetics
Arm Title
Selective shoulder block
Arm Type
Active Comparator
Arm Description
selective block of the suprascapular nerve and the axillary nerve with local anaesthetics
Intervention Type
Procedure
Intervention Name(s)
Interscalene block
Intervention Description
block of the plexus brachialis in the interscalene region with local anaesthetics
Intervention Type
Procedure
Intervention Name(s)
Selective shoulder block
Intervention Description
selective block of the suprascapular nerve and the axillary nerve with local anaesthetics
Primary Outcome Measure Information:
Title
Pain Score as measured by Numeric Rating Scale
Time Frame
24hours
Title
Use of piritramide as documented by the PCIA (patient controlled intravenous analgesia) system
Time Frame
24hours
Secondary Outcome Measure Information:
Title
Subjective feeling of dyspnea as measured by a numeric rating scale
Time Frame
24hours
Title
Motor deficit after nerve block as measured by Medical Research Council scale
Time Frame
24hours
Title
Quality of sleep in the first night after surgery as measured by a numeric rating scale
Time Frame
24hours
Title
Overall satisfaction as measured by the International Pain Outcomes questionnaire
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Schoorens, MD
Organizational Affiliation
Jessa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessaziekenhuis Hasselt
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
29659438
Citation
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.
Results Reference
derived

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

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