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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
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).
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).
Deep neuromuscular block versus moderate neuromuscular block.
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium
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.
Time frame: 1 Day of surgery
Visual analogue scale (VAS)
Scale ranges from 0 to 10 representing respectively no pain and wordt imaginable pain.
Time frame: Day 3 post-operative at 14 o' clock
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).
Time frame: 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).
Time frame: 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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
Analgesic needs
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
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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 1 Day of surgery