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

Status Completed

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.

Clinical Trial 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. ;

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

• NCT number: NCT01881776
• Study type: Interventional
• Source: St. Luke's-Roosevelt Hospital Center
• Status: Completed
• Phase: Phase 0
• Start date: August 2011
• Completion date: June 2012