Early Phase 1 N=70 Randomized Single-blind Supportive Care

Continuous Interscalene Block Results in Superior Recovery Throughout the First Postoperative Week

Postoperative Pain · Adverse Effects

Bottom Line

View on ClinicalTrials.gov: NCT01881776 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

Jun 2014

Primary outcome: Primary: Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4 — 19; 5; 11 participants

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: ISB (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: St. Luke's-Roosevelt Hospital Center
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4	19; 5; 11	—
SECONDARY Time-to-first Pain	11; 26; 2	—
SECONDARY The Number of Patients Consume ≥1 Dose of Analgesics	16; 12; 13	—

Summary

The investigators undertook this prospective, randomized trial to compare the recovery profile throughout the first postoperative week in patients receiving continuous (CISB) interscalene brachial plexus block, single injection (SISB), or general anesthesia (GA) for arthroscopic rotator cuff repair surgery. Specifically, the effects of the three anesthetic techniques when used intraoperatively as a sole anesthesia modality were studied on postoperative pain, time-to-first pain, analgesic consumption, fast-tracked PACU bypass rate, length of PACU stay, time-to-discharge home, sleep duration, and related adverse effects. The investigators hypothesized that CISB results in a superior postoperative recovery profile as compared to SISB or GA alone.

Eligibility Criteria

Inclusion Criteria

American Society of Anesthesiologists (ASA) physical status I-III patients

≥ 18 years of age BMI ≤ 35 kg/m2 Scheduled for elective arthroscopic shoulder surgery

Exclusion Criteria

Patients who were undertaken open shoulder procedures Patients with difficulty understanding the instructions for using the anesthetic infusion pump and/or pain scales Patients with contraindications to regional anesthesia (e.g., allergy to a local anesthetic (LA), local infection, coagulopathy) Patients with significant neurologic disorders of the upper extremity, psychiatric or cognitive disorders, history of substance abuse or chronic opioid use

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Data sourced from ClinicalTrials.gov (NCT01881776). 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.