Shoulder PainPhase 4NCT03643913
The Effect of Deep Neuromuscular Block and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity in Shoulder Surgery Using a Deltopectoral Approach
A Phase 4 study testing Deep neuromuscular block, Moderate neuromuscular block and Neuromuscular Blocking Agents and reversing agents in people with Shoulder Pain and Anesthesia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The study evaluates wether deep neuromuscular block during entire surgical procedure to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach results in less muscular damage to the deltoid muscle and therefore less post-operative pain and an earlier functional recovery.. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain, Anesthesia
- What is being tested?
- Deep neuromuscular block, Moderate neuromuscular block and Neuromuscular Blocking Agents and reversing agents
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Dec 2018to 27 Nov 2024
- Phase
- Phase 4
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient undergoing elective or semi-elective surgery to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach
Who cannot join
- Inability to consent because of mental status
- Open injuries involving the deltoid muscle
- Previous open surgery on the shoulder joint.
- American Society of Anaesthesiologists (ASA) physical status >II
- Age <18 or >85 year old
- Body mass index (BMI) <18.5 or >35 kg/m2
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- Renal insufficiency (glomerular filtration rate <40 ml/min)
- Impaired liver function (hepatic cirrhosis, cholestatic jaundice)
- Neuromuscular disease
- Pregnancy
- Breastfeeding
- Predicted difficult airway
- Patients receiving medications known to interact with neuromuscular blocking agents
- Allergy to any drug included in the anesthetic protocol
Trial locations and contacts
1 site in 1 country.
About this study
The study evaluates wether deep neuromuscular block during entire surgical procedure to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach results in less muscular damage to the deltoid muscle and therefore less post-operative pain and an earlier functional recovery..
- Conditions
- Shoulder Pain, Anesthesia
- Being tested
- Deep neuromuscular block, Moderate neuromuscular block, Neuromuscular Blocking Agents and reversing agents
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep neuromuscular blockProcedure or surgery
Deep neuromuscular block requiring higher doses of Esmeron to target a post tetanic count (PTC) of 1-2 and higher doses of Bridion to reverse the block (4mg/kg).
Moderate neuromuscular blockProcedure or surgery
Normal neuromuscular block requiring dosis of Esmeron to target a train of four (TOF) count of max 2 and lower doses of Bridion to reverse the block (2mg/kg).
Neuromuscular Blocking Agents and reversing agentsDrug
Deep neuromuscular block versus moderate neuromuscular block.
| Study group | Role | What they receive |
|---|---|---|
| Comparison group | Active comparator | Neuromuscular Blocking Agents and reversing agents: The comparison group will receive anesthesia top up Esmeron dose to maintain a Train Of Four (TOF) count of maximum 2 during the whole procedure. This represents moderate neuromuscular block conditions. A neuromuscular monitor (PHILIPS integrated) will be used to evaluate TOF count.
To maintain TOF at 2 and according to our practice a bolus injection of 0,1 mg/kg Rocuronium will be given when TOF count returns to 3. This dose will be repeated if TOF does not go back to 2 within 2 minutes after bolus injection. TOF guard and TOF tube will be used at the ulnar nerve at the contralateral side and will be checked continuously during surgery.
Reversal of the TOF=2 will be done by Sugammadex 2 mg/kg at end of procedure (Time of last suture) Receives: Procedure: Moderate neuromuscular block; Drug: Neuromuscular Blocking Agents and reversing agents |
| Deep group | Experimental | Neuromuscular Blocking Agents and reversing agents: The deep group will receive deep neuromuscular block, using a infusion of Esmeron at 0,1mg/kg/hour. A post tetanic count will be performed and our target will be to have a PTC 1-2. The standard infusion will be adjusted as such. Reversal will be achieved by Sugammadex 4 mg/kg depending on reversal speed at the end of procedure (Time of last suture) Receives: Procedure: Deep neuromuscular block; Drug: Neuromuscular Blocking Agents and reversing agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Leiden score
the surgeon will be asked to score the surgical conditions on a five step scale based upon previously used scales:
- grade 5: optimal surgical conditions, perfect access to the proximal humerus, glenohumeral joint and excellent visibility.
- grade 4: good conditions: adequate surgical conditions to perform the surgery, but not optimal
- grade 3: acceptable conditions, surgical procedure is jeopardized, but adequate surgical result is obtained, eventually after additional intervention
- grade 2: poor conditions, exposure and handling hindered resulting in suboptimal surgical outcome
- grade 1: extremely poor conditions, the surgeon is unable to work because of the inability to get access to the shoulder joint because of inadequate muscle relaxation.
Measured: 1 Day of surgery
Visual analogue scale (VAS)
Scale ranges from 0 to 10 representing respectively no pain and wordt imaginable pain.
Measured: Day 3 post-operative at 14 o' clock
Secondary outcomes (9)
Muscular damage
Two light photos will be taken before closure of the deltoideopectoral interval to document the muscular damage by the surgeon using a grading score (1-4, 1=no muscular damage, 2=superficial damage (fraying) or contusion, 3=muscular tear < 1 cm depth, 4=muscular tear > 1 cm depth).
Measured: 1 Day of surgery
Muscular damage
Two light photos will be taken before closure of the deltoideopectoral interval to document the muscular damage by two independent reviewers (surgeons blinded to the procedure) using a grading score (1-4, 1=no muscular damage, 2=superficial damage (fraying) or contusion, 3=muscular tear < 1 cm depth, 4=muscular tear > 1 cm depth).
Measured: 1 year after inclusion
VAS
Scale ranges from 0 to 10 representing respectively no pain and worst imaginable pain. Post-operative pain will be scored using a VAS-pain scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: The scoring will be done at 8-14 and 20 o'clock on days 1-3-5 post-operative and once a day from day 5 to day 30 post-operative.
Analgesic needs
The analgesic needs of the patient during hospitalization will be derived from the Electronic Medical Prescription (EMV) module of the Electronic patient file system. The total morphine consumption will be assessed in all groups as well as rescue medication such as ketalar, NSAID's catapressan and paracetamol.
Measured: Up to 5 days post-operative
Analgesic needs
The analgesic needs of the patient after hospitalization will be derived from a patient diary.
Measured: From hospital discharge to 30 days post-operative
Length of stay at post-anesthesia care unit (PACU)
Evaluation and length of stay at the PACU will also be examined as this clearly reflects the amount of post-operative comfort or possible adverse effects witnessed post procedure. The parameter will be expressed in hours and there will be two measurement. The time of expected discharge and the actual discharge (with reasons of possible delay between those two figures expressed in minutes or hours).
Measured: 1 Day of surgery
Length of surgery
Will be expressed in %. As different procedures are being performed within this study, absolute length would not be indicative for ease of procedure. Therefore we express length of surgery as actual length of the procedure (incision to closure), divided by the mean length of the 10 last identical procedures (out of the study) performed by the same surgeon.
Measured: intraoperative
Length of stay
Is defined as post-operative length of stay, the day of surgery being day 0. This parameter will be expressed in days. As post-operative pain is one of the principal reasons for hospitalization after shoulder surgery, we believe this parameter is an indirect measure for post-operative pain.
Measured: from day 3 up to 3 weeks after surgery
Evaluation of dry catheter technique
Evaluation of the efficacy of the catheter will be done 30 minutes after the bolus injection. Efficacy will be tested by using ether swab to test sensory block and also motorfunction evaluation of the motorjoint (raising arm to full height pass/fail).
Measured: 1 Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start18 Dec 2018
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- MSD Belgium BVBA
- Responsible party
- Principal investigator, Harm Hoekstra, prof. dr., Universitaire Ziekenhuizen KU Leuven
- Investigators
- Harm Hoekstra, Prof. Dr., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643913
- Sponsor's protocol ID
- NS918
- Status last verified
- Dec 2024
- First submitted
- 6 Aug 2018
- Last updated
- 12 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Neuromuscular Block and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity in Shoulder Surgery Using a Deltopectoral Approach
- ClinicalTrials.gov ID
- NCT03643913
- Acronym / sponsor ID
- NS918
- Conditions
- Shoulder Pain, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- MSD Belgium BVBA
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates wether deep neuromuscular block during entire surgical procedure to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach results in less muscular damage to the deltoid muscle and therefore less post-operative pain and an earlier functional recovery..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison group | Active comparator | Procedure: Moderate neuromuscular block, Drug: Neuromuscular Blocking Agents and reversing agentsNeuromuscular Blocking Agents and reversing agents: The comparison group will receive anesthesia top up Esmeron dose to maintain a Train Of Four (TOF) count of maximum 2 during the whole procedure. This represents moderate neuromuscular block conditions. A neuromuscular monitor (PHILIPS integrated) will be used to evaluate TOF count. To maintain TOF at 2 and according to our practice a bolus injection of 0,1 mg/kg Rocuronium will be given when TOF count returns to 3. This dose will be repeated if TOF does not go back to 2 within 2 minutes after bolus injection. TOF guard and TOF tube will be used at the ulnar nerve at the contralateral side and will be checked continuously during surgery. Reversal of the TOF=2 will be done by Sugammadex 2 mg/kg at end of procedure (Time of last suture) |
| Deep group | Experimental | Procedure: Deep neuromuscular block, Drug: Neuromuscular Blocking Agents and reversing agentsNeuromuscular Blocking Agents and reversing agents: The deep group will receive deep neuromuscular block, using a infusion of Esmeron at 0,1mg/kg/hour. A post tetanic count will be performed and our target will be to have a PTC 1-2. The standard infusion will be adjusted as such. Reversal will be achieved by Sugammadex 4 mg/kg depending on reversal speed at the end of procedure (Time of last suture) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient undergoing elective or semi-elective surgery to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach
Key exclusion criteria (14 listed)
- Inability to consent because of mental status
- Open injuries involving the deltoid muscle
- Previous open surgery on the shoulder joint.
- American Society of Anaesthesiologists (ASA) physical status >II
- Age <18 or >85 year old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep neuromuscular blockDeep neuromuscular block requiring higher doses of Esmeron to target a post tetanic count (PTC) of 1-2 and higher doses of Bridion to reverse the block (4mg/kg). | Procedure or surgery | Deep group |
| Moderate neuromuscular blockNormal neuromuscular block requiring dosis of Esmeron to target a train of four (TOF) count of max 2 and lower doses of Bridion to reverse the block (2mg/kg). | Procedure or surgery | Comparison group |
| Neuromuscular Blocking Agents and reversing agentsDeep neuromuscular block versus moderate neuromuscular block. | Drug | Comparison group, Deep group |
Primary outcome
Modified Leiden score
Time frame: 1 Day of surgery
the surgeon will be asked to score the surgical conditions on a five step scale based upon previously used scales: * grade 5: optimal surgical conditions, perfect access to the proximal humerus, glenohumeral joint and excellent visibility. * grade 4: good conditions: adequate surgical conditions to perform the surgery, but not optimal * grade 3: acceptable conditions, surgical procedure is jeopardized, but adequate surgical result is obtained, eventually after additional intervention * grade 2: poor conditions, exposure and handling hindered resulting in suboptimal surgical outcome * grade 1: extremely poor conditions, the surgeon is unable to work because of the inability to get access to the shoulder joint because of inadequate muscle relaxation.
Visual analogue scale (VAS)
Time frame: Day 3 post-operative at 14 o' clock
Scale ranges from 0 to 10 representing respectively no pain and wordt imaginable pain.
9 secondary outcomes
Muscular damage
Time frame: 1 Day of surgery
Muscular damage
Time frame: 1 year after inclusion
VAS
Time frame: The scoring will be done at 8-14 and 20 o'clock on days 1-3-5 post-operative and once a day from day 5 to day 30 post-operative.
Analgesic needs
Time frame: Up to 5 days post-operative
Analgesic needs
Time frame: From hospital discharge to 30 days post-operative
Length of stay at post-anesthesia care unit (PACU)
Time frame: 1 Day of surgery
Length of surgery
Time frame: intraoperative
Length of stay
Time frame: from day 3 up to 3 weeks after surgery
Evaluation of dry catheter technique
Time frame: 1 Day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harm Hoekstra, Prof. Dr. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Deep neuromuscular block, Moderate neuromuscular block and Neuromuscular Blocking Agents and reversing agents in people with Shoulder Pain and Anesthesia, run by Universitaire Ziekenhuizen KU Leuven 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 1 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 12 Dec 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Modified Leiden score (time frame: 1 Day of surgery). 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?
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 12 Dec 2024.