The Effect of Deep Neuromuscular Block and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity in Shoulder Surgery Using a Deltopectoral Approach
- Conditions
- Shoulder PainAnesthesia
- Interventions
- Procedure: Moderate neuromuscular blockProcedure: Deep neuromuscular blockDrug: Neuromuscular Blocking Agents and reversing agents
- Registration Number
- NCT03643913
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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..
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
• Adult patient undergoing elective or semi-elective surgery to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparison group Moderate neuromuscular block 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) Comparison group Neuromuscular Blocking Agents and reversing agents 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) Deep group Neuromuscular Blocking Agents and reversing agents 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) Deep group Deep neuromuscular block 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)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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.
Muscular damage 1 year after inclusion 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 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).
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.
Analgesic needs From hospital discharge to 30 days post-operative The analgesic needs of the patient after hospitalization will be derived from a patient diary.
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).
Trial Locations
- Locations (1)
University Hospitals Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium