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

Postoperative Pain Clinical Trial

Official title:

Continuous Interscalene Block in Patients Having Outpatient Rotator Cuff Repair Surgery: a Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881776
• Other study ID #: 10142
• Status: Completed
• Phase: Phase 0
• First received: February 26, 2013
• Last updated: May 5, 2014
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Background The advantages of single injection (SISB) and continuous interscalene brachial plexus block (CISB) over general anesthesia (GA) only have been previously reported. However, few studies extended their observations beyond 48 postoperative hours, and no study has compared the effects of SISB and CISB as sole anesthesia modalities with GA only. We undertook this randomized trial to compare the recovery profile of patients receiving SISB, CISB or GA for arthroscopic rotator cuff repair surgery through the first postoperative week. Our primary hypothesis was that highest NRS pain rating (worst pain score) at the end of the study week is lower for patients in the CISB group than for patients in the SISB or GA groups.

Methods After Institutional Review Board approval and informed consents were obtained, 71 patients of American Society of Anesthesiologists (ASA) physical status I-III, ≥18 years of age, and BMI≤35 kg/m2, scheduled for elective outpatient arthroscopic rotator cuff repair, were enrolled. CISB patients received 20 mL of 0.5% ropivacaine as bolus through the catheter whereas SISB patients received the same volume of injection through a needle. CISB patients received an infusion of 0.2% ropivacaine at 5mL/h with a patient controlled bolus of 5 mL hourly. GA only patients received a standardized general anesthetic. All patients were prescribed acetaminophen (500mg) with hydrocodone (7.5mg) every 4h as needed. CISB was discontinued 48 h after surgery. Postoperative highest pain scores (NRS) through the first postoperative week, time-to-first pain, analgesic consumption, fast-tracked postoperative care unit (PACU) bypass rate, length of PACU stay, time-to-discharge home, sleep duration, and related adverse effects were recorded in the PACU and at home on postoperative days 1, 2, 3, and 7.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Adverse Effects
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• ISB
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.

Locations

Country	Name	City	State
United States	St Luke's Roosevelt Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number	To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using fast-tracked PACU bypass rate	throughout the first postoperative week (how many patients left PACU immediately just after the operation)	No
Other	Length of PACU Stay	To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using length of PACU stay.	throughout the first postoperative week (how long patients stayed in PACU just after the operation)	No
Other	Time to Discharge Home	To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using time-to-discharge home.	throughout the first postoperative week (how long patients stayed in the hospital (includes PACU and hospital time)	No
Other	Total Hours of Sleep	To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using sleep duration.	first postoperative week (on day 7)	No
Primary	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	Yes
Secondary	Time-to-first Pain	The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (time-to-first pain).	throughout the first postoperative week	Yes
Secondary	The Number of Patients Consume =1 Dose of Analgesics	The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (analgesic consumption).	throughout the first postoperative week	Yes