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Completed

NCT Number: NCT03224884

Interscalene Block Versus Supraclavicular Block for Shoulder Surgery

Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder surgery. However it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease.

This randomized controlled trial will compare ultrasound-guided interscalene block (ISB) and supraclavicular block in patients undergoing arthroscopic shoulder surgery.

The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rate scale (NRS) from 0 to 10.

Our research hypothesis is that interscalene and supraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points

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Key information

Conditions

Pain, Postoperative Arthralgia Diaphragmatic Paralysis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Insufficiency Respiratory Paralysis Respiratory Tract Diseases Shoulder Pain Signs and Symptoms Surgical Procedure, Unspecified

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinico Universidad de Chile

Santiago, Metropolitan, 8380456, Chile

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing arthroscopic shoulder surgery
  • American Society of Anesthesiologists classification 1-3
  • Body mass index between 20 and 35

Exclusion criteria

  • Adults who are unable to give their own consent
  • Pre-existing neuropathy
  • Coagulopathy
  • Obstructive or restrictive pulmonary disease
  • Renal failure
  • Hepatic failure
  • Allergy to local anesthetics
  • Pregnancy
  • Prior surgery in the corresponding side of the neck or supraclavicular fossa
  • Chronic pain syndromes requiring opioid intake at home

Treatment and study plan

interscalene block

Procedure

Ultrasound guided brachial plexus block injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in the interscalene groove, under the prevertebral fascia.

Supraclavicular block

Procedure

Ultrasound guided brachial plexus injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL (3 mL in the "corner pocket" followed by 17 mL posterolateral to the brachial plexus).

Primary outcomes

  1. Static pain at 30 minutes after arrival in the PACU

    Time frame: 30 minutes

    Evaluated with a NRS from 0 to 10.

Secondary outcomes

  1. Static pain at 60 minutes after arrival in the PACU

    Time frame: 60 minutes

    Evaluated with a NRS from 0 to 10.

  2. Postoperative static pain at 2 hours

    Time frame: 2 hours

    Evaluated with a NRS from 0 to 10.

  3. Postoperative static pain at 3 hours

    Time frame: 3 hours

    Evaluated with a NRS from 0 to 10.

  4. Postoperative static pain at 6 hours

    Time frame: 6 hours

    Evaluated with a NRS from 0 to 10.

  5. Postoperative static pain at 12 hours

    Time frame: 12 hours

    Evaluated with a NRS from 0 to 10.

  6. Postoperative static pain at 24 hours

    Time frame: 24 hours

    Evaluated with a NRS from 0 to 10.

  7. Incidence of HDP at 30 minutes after interscalene or supraclavicular block

    Time frame: 30 minutes post injection

    Ultrasound diagnosed HDP

  8. Incidence of HDP at 30 minutes after arrival to PACU.

    Time frame: 30 minutes after arrival to PACU

    Ultrasound diagnosed HDP

  9. Block performance time

    Time frame: 1 hour before surgery

    Time from skin desinfection until the end of local anesthetic injection.

  10. Sensory and Motor block

    Time frame: 30 minutes post injection

    Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score.

  11. Incidence of complete block

    Time frame: 30 minutes post injection

    Percentage of blocks with a minimal sensorimotor composite score of 6 points out of a maximum of 8 points at 30 minutes post injection.

  12. Procedural pain during blocks

    Time frame: 1 hour before surgery

    Evaluated with a NRS from 0 to 10.

  13. Onset time

    Time frame: 1 hour before surgery

    Time required to reach a minimal sensorimotor composite score of 6 points out of a maximum of 8 points.

  14. Intraoperative opioid requirements

    Time frame: Intraoperative period

    Total amount of fentanyl required during general anesthesia.

  15. Surgical duration

    Time frame: intraoperative period

    Time between skin incision and closure.

  16. Postoperative opioid consumption

    Time frame: 24 hours after surgery

    Total amount of morphine required during the first 24 hours after surgery.

  17. Patient satisfaction

    Time frame: 24 hours after surgery

    Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 = very satisfied).

  18. Block- and opioid-related side effects

    Time frame: 1 week

    Incidence of side effects.

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

A Randomized Comparison Between Interscalene and Supraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2017
Registry last updated
Nov 14, 2017

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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