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The Effect of Deep Neuromuscular Block and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity in Shoulder Surgery Using a Deltopectoral Approach

Primary Purpose

Shoulder Pain, Anesthesia

Status
Recruiting
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Deep neuromuscular block
Moderate neuromuscular block
Neuromuscular Blocking Agents and reversing agents
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Adult patient undergoing elective or semi-elective surgery to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • University Hospitals LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Comparison group

Deep group

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.
Visual analogue scale (VAS)
Scale ranges from 0 to 10 representing respectively no pain and wordt imaginable pain.

Secondary Outcome Measures

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).
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).
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).
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.
Analgesic needs
The analgesic needs of the patient after hospitalization will be derived from a patient diary.
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).
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.
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.
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).

Full Information

First Posted
August 6, 2018
Last Updated
August 9, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
MSD Belgium BVBA
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1. Study Identification

Unique Protocol Identification Number
NCT03643913
Brief Title
The Effect of Deep Neuromuscular Block and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity in Shoulder Surgery Using a Deltopectoral Approach
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
MSD Belgium BVBA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The patient and the surgeon are blinded for the intervention. The anesthesist knows the allocation.
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comparison group
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Deep group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Deep neuromuscular block
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Moderate neuromuscular block
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Neuromuscular Blocking Agents and reversing agents
Intervention Description
Deep neuromuscular block versus moderate neuromuscular block.
Primary Outcome Measure Information:
Title
Modified Leiden score
Description
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.
Time Frame
1 Day of surgery
Title
Visual analogue scale (VAS)
Description
Scale ranges from 0 to 10 representing respectively no pain and wordt imaginable pain.
Time Frame
Day 3 post-operative at 14 o' clock
Secondary Outcome Measure Information:
Title
Muscular damage
Description
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).
Time Frame
1 Day of surgery
Title
Muscular damage
Description
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).
Time Frame
1 year after inclusion
Title
VAS
Description
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).
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.
Title
Analgesic needs
Description
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.
Time Frame
Up to 5 days post-operative
Title
Analgesic needs
Description
The analgesic needs of the patient after hospitalization will be derived from a patient diary.
Time Frame
From hospital discharge to 30 days post-operative
Title
Length of stay at post-anesthesia care unit (PACU)
Description
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).
Time Frame
1 Day of surgery
Title
Length of surgery
Description
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.
Time Frame
intraoperative
Title
Length of stay
Description
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.
Time Frame
from day 3 up to 3 weeks after surgery
Title
Evaluation of dry catheter technique
Description
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).
Time Frame
1 Day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Adult patient undergoing elective or semi-elective surgery to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elga Nijs, BSN
Phone
016 34 23 64
Ext
0032
Email
elga.nijs@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Ceuleers
Phone
016 34 46 66
Ext
0032
Email
kathleen.ceuleers@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harm Hoekstra, Prof. Dr.
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harm Hoekstra, Prof. Dr.
Phone
016 34 1327
Ext
0032
Email
harm.hoekstra@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Steve Coppens, Dr.
First Name & Middle Initial & Last Name & Degree
Arne Neyrinck, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Willem Metsemakers, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Harm Hoekstra, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Deep Neuromuscular Block and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity in Shoulder Surgery Using a Deltopectoral Approach

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