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NCT Number: NCT02576223

Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery

The purpose of this randomized study is to examine the effect of a selective suprascapular nerve block on post operative pain after arthroscopic shoulder surgery. Half of the subjects will receive a active nerve block with Ropivacain. Half of the subjects will receive a placebo nerve block with saline.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nordsjællands Hospital, Hillerød, Denmark

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About this study

Postoperative pain management after arthroscopic shoulder surgery traditionally includes opioids and/or an interscalene brachial plexus block(IBPB). Opioid consumption often leads to unpleasant side effects including nausea, vomitting and sedation. IBPB offers very efficient pain relief but includes the discomfort of a paralyzed arm. Furthermore this approach often also leads to unilateral paresis of the phrenic nerve causing reduced respiratory capacity. The latter offering discomfort and a potential risk in patients with lung diseases or heavy overweight.

The suprascapular nerve is the most important nerve to the shoulder and a selective block of this nerve could offer a good pain relief without the mentioned side effects.

In this randomized study the investigators wish to examine the pain relieving effect of a selective block of the suprascapular nerve after arthroscopic shoulder surgery.

40 patients are randomized to a block of this nerve with either active drug (Ropivacaine) or placebo (Saline). All patients will get a PCA (Patient Controlled Analgesia) pump for administration of i.v. morphine in doses based on age and weight.

Patient are being monitored for 6 hours. The primary outcome is reduction in VAS at rest from baseline to 30 minutes after nerve block.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients planned for arthroscopic shoulder surgery.
  • Age ≥ 18.
  • ASA class ≤ 3.

Exclusion criteria

  • Patients with VAS never ≥5 mm during the first hour after arrivel to the post anesthesia care unit.
  • Patients unable to cooperate.
  • Patients unable to understand or speak danish.
  • Allergy towards the used drugs.
  • Abuse of alcohol- and/or medicine - investigators assessment.
  • Usage of opioids on a daily basis (not including Tramadole).
  • Pregnancy (It is obligatory for all fertile women in the study to take a hcg urine test).
  • Operations involving the clavicle.
  • Operations converted to open surgery.

Treatment and study plan

Ropivacaine hydrochloride

Drug

Ropivacaine injected perineural at the suprascapular nerve.

Other names: Ropivacaine, Naropin

Isotonic saline

Drug

Saline injected perineural at the suprascapular nerve.

Other names: Saline

PCA-pump

Drug

PCA (Patient controlled analgesia) pump with the following settings:

Age > 70 years or weight < 60 kg: bolus dose 2,5 mg i.v. morphine, 15 minutes lockout Age < 70 years and weight > 60 kg: bolus dose 5 mg i.v. morphine, 15 minutes lockout Lockout time 15 minutes.

Other names: Morphine

Primary outcomes

  1. Visual analogue scale (VAS) score at rest at T½

    Time frame: Baseline to 30 minutes

    Change in VAS score at rest from baseline to 30 minutes after nerve block (T½).

Secondary outcomes

  1. VAS score during maximum active shoulder abduction from T½ to T6

    Time frame: ½, 1, 2, 3, 4, 5, 6 hours

    VAS scores measured at 7 timepoints (T½, T1, T2, T3, T4, T5, T6) during maximal active shoulder abduction and calculated as area under the curve (AUC).

  2. VAS score at rest from T½ to T6

    Time frame: ½, 1, 2, 3, 4, 5, 6 hours

    VAS scores measured at 7 timepoints (T½, T1, T2, T3, T4, T5, T6) at rest and calculated as area under the curve (AUC).

  3. Morphine consumption.

    Time frame: 6 hours

    The total amount of morphine administered via the intravenous PCA pump the first 6 hours after nerve block.

  4. Electromyography at T½

    Time frame: Baseline to 30 minutes

    Change in activity of the infraspinatus muscle measured with surface electromyography from baseline to T½.

  5. Muscle strength at T½

    Time frame: Baseline to 30 minutes

    Change in strength of the supraspinatus (abduction of the shoulder) and the infraspinatus muscle (external rotation of the shoulder) measured with a handheld dynamometer from baseline to T½.

Sponsors and collaborators

Lead sponsor

Kai Henrik Wiborg Lange

Other

Registry information

Official study title

Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery - a Randomized, Blinded, Placebo Controlled Study

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 15, 2015
Registry last updated
Mar 21, 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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