Shoulder Pain, Anesthesia
Conditions
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..
Interventions
PROCEDUREDeep neuromuscular block
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).
PROCEDUREModerate neuromuscular block
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).
DRUGNeuromuscular Blocking Agents and reversing agents
Deep neuromuscular block versus moderate neuromuscular block.
Sponsors
MSD Belgium BVBA
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The patient and the surgeon are blinded for the intervention. The anesthesist knows the allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Leiden score | 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) | Day 3 post-operative at 14 o' clock | Scale ranges from 0 to 10 representing respectively no pain and wordt imaginable pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscular damage | 1 Day of surgery | 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). |
| VAS | 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. | 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 | Up to 5 days post-operative | 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. |
| Length of stay at post-anesthesia care unit (PACU) | 1 Day of surgery | 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 | intraoperative | 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 | from day 3 up to 3 weeks after surgery | 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 | 1 Day of surgery | 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). |
Countries
Belgium
Outcome results
None listed