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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03643913
• Other study ID #: NS918
• Status: Recruiting
• Phase: Phase 4
• Start date: December 18, 2018
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Elga Nijs, BSN
• Phone: 016 34 23 64
• Email: elga.nijs[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Shoulder Pain

Intervention

Procedure:
• Deep 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).
• Moderate 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).

Drug:
• Neuromuscular Blocking Agents and reversing agents
Deep neuromuscular block versus moderate neuromuscular block.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	MSD Belgium BVBA

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 Day of surgery
Primary	Visual analogue scale (VAS)	Scale ranges from 0 to 10 representing respectively no pain and wordt imaginable pain.	Day 3 post-operative at 14 o' clock
Secondary	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).	1 Day of surgery
Secondary	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).	1 year after inclusion
Secondary	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).	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.
Secondary	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.	Up to 5 days post-operative
Secondary	Analgesic needs	The analgesic needs of the patient after hospitalization will be derived from a patient diary.	From hospital discharge to 30 days post-operative
Secondary	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).	1 Day of surgery
Secondary	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.	intraoperative
Secondary	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.	from day 3 up to 3 weeks after surgery
Secondary	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).	1 Day of surgery