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Phase 4 N=126 Randomized Triple-blind Treatment

Interscalene Block Versus Superior Trunk Block

Joint Disease · Pain · Pain, Acute · Pain, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT03272139 ↗
Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP) — 45; 3; 18; 59 participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Bupivacaine (Drug); Ultrasound (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Hospital for Special Surgery, New York
Primary completion
Dec 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)		 45; 3; 18; 59 —
PRIMARY
Numerical Pain Rating System (NRS) Pain Scores		 0; 0 —
SECONDARY
Block Duration		 23.18; 23.15 —

Summary

Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair, stabilization, rotator cuff repair).

Eligibility Criteria

Inclusion Criteria

  • Patients who will be undergoing primary unilateral labral repair/stabilization of the shoulder
  • Age 18 to 80 years
  • Planned use of general anesthesia with LMA and interscalene or superior trunk block
  • Ability to follow study protocol
  • English speaking
  • ASA I - III

Exclusion Criteria

Pre-existing neuropathy of the operative limb

  • Younger than 18 years old and older than 80
  • Patients with pulmonary severe respiratory disease
  • Allergy to one of the study medications
  • Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
  • Chronic opioid use (taking opioids for longer than 3 months)
  • Contraindication to general anesthesia, interscalene or superior trunk block
  • Herniated Cervical Disk, Cervical Myelopathy
  • BMI >35
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03272139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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