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1.
J Am Geriatr Soc ; 64(12): 2433-2439, 2016 12.
Article in English | MEDLINE | ID: mdl-27787895

ABSTRACT

OBJECTIVES: To compared outcomes of regional nerve blocks with those of standard analgesics after hip fracture. DESIGN: Multisite randomized controlled trial from April 2009 to March 2013. SETTING: Three New York hospitals. PARTICIPANTS: Individuals with hip fracture (N = 161). INTERVENTION: Participants were randomized to receive an ultrasound-guided, single-injection, femoral nerve block administered by emergency physicians at emergency department (ED) admission followed by placement of a continuous fascia iliaca block by anesthesiologists within 24 hours (n = 79) or conventional analgesics (n = 82). MEASUREMENTS: Pain (0-10 scale), distance walked on Postoperative Day (POD) 3, walking ability 6 weeks after discharge, opioid side effects. RESULTS: Pain scores 2 hours after ED presentation favored the intervention group over controls (3.5 vs 5.3, P = .002). Pain scores on POD 3 were significantly better for the intervention than the control group for pain at rest (2.9 vs 3.8, P = .005), with transfers out of bed (4.7 vs 5.9, P = .005), and with walking (4.1 vs 4.8, P = .002). Intervention participants walked significantly further than controls in 2 minutes on POD 3 (170.6 feet, 95% confidence interval (CI) = 109.3-232 vs 100.0 feet, 95% CI = 65.1-134.9; P = .04). At 6 weeks, intervention participants reported better walking and stair climbing ability (mean Functional Independence Measure locomotion score of 10.3 (95% CI = 9.6-11.0) vs 9.1 (95% CI = 8.2-10.0), P = .04). Intervention participants were significantly less likely to report opioid side effects (3% vs 12.4%, P = .03) and required 33% to 40% fewer parenteral morphine sulfate equivalents. CONCLUSION: Femoral nerve blocks performed by emergency physicians followed by continuous fascia iliaca blocks placed by anesthesiologists are feasible and result in superior outcomes.


Subject(s)
Hip Fractures/surgery , Nerve Block/methods , Pain Management/methods , Pain, Postoperative/prevention & control , Aged , Aged, 80 and over , Female , Femoral Nerve , Humans , Male , Middle Aged , New York , Pain Measurement , Recovery of Function , Treatment Outcome , Ultrasonography, Interventional
2.
J Acquir Immune Defic Syndr ; 46(5): 538-46, 2007 Dec 15.
Article in English | MEDLINE | ID: mdl-18193495

ABSTRACT

OBJECTIVE: To assess the safety of the candidate microbicide Carraguard gel in HIV-positive women and men. DESIGN: A randomized, placebo-controlled, triple-blinded clinical trial of Carraguard gel when applied vaginally once per day for 14 intermenstrual days by sexually abstinent and sexually active HIV-positive women; and when applied directly to the penis once per day for 7 days by sexually abstinent HIV-positive men. METHODS: In each cohort (n = 20 per cohort), participants were randomized to Carraguard, methylcellulose placebo, or no product (1:1:1). In addition to traditional microbicide trial safety endpoints, the effects of microbicide use on vaginal shedding of HIV-1 RNA and markers of genital inflammation, epithelial sloughing, and microhemorrhage were also explored. RESULTS: Gel compliance was high in both gel-use groups in the 3 cohorts. Carraguard use was not associated with abnormal genital findings, other abnormal clinical findings, markers of genital inflammation, epithelial sloughing or microhemorrhage, or self-reported symptoms in women and men, or with abnormal vaginal flora or genital shedding of HIV-1 RNA in women. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups. CONCLUSIONS: Once-daily use of Carraguard for 7 to 14 days appeared to be safe in HIV-positive women and men.


Subject(s)
Anti-Infective Agents, Local/adverse effects , HIV Infections/prevention & control , Vaginal Creams, Foams, and Jellies/adverse effects , Adult , Anti-Infective Agents, Local/administration & dosage , Double-Blind Method , Female , Female Urogenital Diseases/pathology , Humans , Male , Male Urogenital Diseases/pathology , Middle Aged , Placebos/administration & dosage , RNA, Viral/genetics , South Africa , Vagina/pathology , Vagina/virology , Vaginal Creams, Foams, and Jellies/administration & dosage , Virus Shedding
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