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Completed

NCT Number: NCT03643913

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..

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep neuromuscular block

Procedure

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

Procedure

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).

Neuromuscular Blocking Agents and reversing agents

Drug

Deep neuromuscular block versus moderate neuromuscular block.

Primary outcomes

  1. Modified Leiden score

    Time frame: 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.
  2. Visual analogue scale (VAS)

    Time frame: Day 3 post-operative at 14 o' clock

    Scale ranges from 0 to 10 representing respectively no pain and wordt imaginable pain.

Secondary outcomes

  1. Muscular damage

    Time frame: 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).

  2. Muscular damage

    Time frame: 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).

  3. VAS

    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.

    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).

  4. Analgesic needs

    Time frame: 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.

  5. Analgesic needs

    Time frame: From hospital discharge to 30 days post-operative

    The analgesic needs of the patient after hospitalization will be derived from a patient diary.

  6. Length of stay at post-anesthesia care unit (PACU)

    Time frame: 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).

  7. Length of surgery

    Time frame: 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.

  8. Length of stay

    Time frame: 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.

  9. Evaluation of dry catheter technique

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • MSD Belgium BVBA

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 23, 2018
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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