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

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 Overview

• Status: Recruiting
• Conditions: Shoulder Pain; Anesthesia
• Intervention / Treatment: Procedure: Moderate neuromuscular block; Drug: Neuromuscular Blocking Agents and reversing agents; Procedure: Deep neuromuscular block

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Elga Nijs, BSN; Phone Number: 0032 016 34 23 64; Email: elga.nijs@uzleuven.be
• Study Contact Backup: Name: Kathleen Ceuleers; Phone Number: 0032 016 34 46 66; Email: kathleen.ceuleers@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • University Hospitals Leuven
      • Contact: Harm Hoekstra, Prof. Dr.; Phone Number: 0032 016 34 1327; Email: harm.hoekstra@uzleuven.be
      • Sub-Investigator: Steve Coppens, Dr.
      • Sub-Investigator: Arne Neyrinck, Prof. Dr.
      • Sub-Investigator: Willem Metsemakers, Prof. Dr.
      • Principal Investigator: Harm Hoekstra, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Comparison group; 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)	Procedure: 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.
Experimental: Deep group; 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)	Drug: Neuromuscular Blocking Agents and reversing agents; Deep neuromuscular block versus moderate neuromuscular block.; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: MSD Belgium BVBA
• Investigators: Principal Investigator: Harm Hoekstra, Prof. Dr., Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2018
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Blocking Agents
• Other Study ID Numbers: NS918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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