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

NCT01881776 | Completed Early Phase 1 Results DMC

• 1 other identifier: 10142
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Adverse Effects

Keywords

Single injection interscalene brachial plexus block; Continuous interscalene brachial plexus block; General anesthesia; Postoperative pain; Recovery profile

Outcome Measures

Primary Outcomes (1)

• Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4

  The effects of the three anesthetic techniques (continuous interscalene brachial plexus block (CISB), single interscalene brachial plexus block (SISB), or general anesthesia (GA)) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (highest NRS pain rating)

  throughout the first postoperative week on days 1, 2, 3, and 7

Secondary Outcomes (2)

• Time-to-first Pain

  throughout the first postoperative week

• The Number of Patients Consume ≥1 Dose of Analgesics

  throughout the first postoperative week

Other Outcomes (4)

• Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number

  throughout the first postoperative week (how many patients left PACU immediately just after the operation)

• Length of PACU Stay

  throughout the first postoperative week (how long patients stayed in PACU just after the operation)

• Time to Discharge Home

  throughout the first postoperative week (how long patients stayed in the hospital (includes PACU and hospital time)

Study Arms (3)

Single ISB (SISB) group

ACTIVE COMPARATOR

Patients in this group received single injection (SISB) interscalene brachial plexus block

Procedure: ISB

Continuous ISB (CISB) group

ACTIVE COMPARATOR

Patients in this group received continuous (CISB) interscalene brachial plexus block

Procedure: ISB

General anesthesia (GA) group

NO INTERVENTION

Patients in this group received general anesthesia (GA)

Interventions

ISB PROCEDURE

In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Also known as: SISB needle (Stimuplex®A, B Braun), CISB needle and catheter (Contiplex® Tuohy, B. Braun)

Continuous ISB (CISB) group; Single ISB (SISB) group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-III patients
• ≥ 18 years of age BMI ≤ 35 kg/m2 Scheduled for elective arthroscopic shoulder surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

St Luke's Roosevelt Hospital Center

New York, New York, 10025, United States

Location

Related Publications (1)

• Salviz EA, Xu D, Frulla A, Kwofie K, Shastri U, Chen J, Shariat AN, Littwin S, Lin E, Choi J, Hobeika P, Hadzic A. Continuous interscalene block in patients having outpatient rotator cuff repair surgery: a prospective randomized trial. Anesth Analg. 2013 Dec;117(6):1485-92. doi: 10.1213/01.ane.0000436607.40643.0a.

  PMID: 24257398 DERIVED

Related Links

• SINGLE INJECTION ISB
• CONTINUOUS ISB

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Catheters

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Limitations and Caveats

1\. It was difficult to keep three different groups blinded. 2. The resting and mobilization highest/worst NRS pain scores were ignored and only the highest pain scores of the postoperative days 1, 2, 3, and 7 were recorded.

Results Point of Contact

• Title: Dr.Admir Hadzic
• Organization: StLukeNY

admir@nysora.com

212-665-1400

Study Officials

• Admir Hadzic, MD,PhD,Prof

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: June 20, 2013
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 4, 2014
• Results First Posted: June 4, 2014

Record last verified: 2013-07

Locations

US (1)