17 research outputs found
Postoperative Analgesia after Radical Retropubic Prostatectomy
Background: Postoperative pain after radical retropubic prostatectomy can be severe unless adequately treated. Low thoracic epidural analgesia and patient-controlled intravenous analgesia were compared in this double-blind, randomized study. Methods: Sixty patients were randomly assigned to receive either low thoracic epidural analgesia (group E) or patientcontrolled intravenous analgesia (group P) for postoperative pain relief. All patients had general anesthesia combined with thoracic epidural analgesia during the operation. Postoperatively, patients in group E received an infusion of 1 mg/ml ropivacaine, 2 g/ml fentanyl, and 2 g/ml adrenaline, 10 ml/h during 48 h epidurally, and a placebo patient-controlled intravenous analgesia pump intravenously. Patients in group P received a patient-controlled intravenous analgesia pump with morphine intravenously and 10 ml/h placebo epidurally. Pain, the primary outcome variable, was measured using the numeric rating scale at rest (incision pain and "deep" visceral pain) and on coughing. Secondary outcome variables included gastrointestinal function, respiratory function, mobilization, and full recovery. Health-related quality of life was measured using the Short Form-36 questionnaire, and plasma concentration of fentanyl was measured in five patients to exclude a systemic effect of fentanyl. Results: Incisional pain and pain on coughing were lower in group E compared with group P at 2-24 h, as was deep pain between 3 and 24 h postoperatively (P < 0.05). Maximum expiratory pressure was greater in group E at 4 and 24 h (P < 0.05) compared with group P. No difference in time to home discharge was found between the groups. The mean plasma fentanyl concentration varied from 0.2 to 0.3 ng/ml during 0 -48 h postoperatively. At 1 month, the scores on emotional role, physical functioning, and general health of the Short Form-36 were higher in group E compared with group P. However, no group ؋ time interaction was found in the Short Form-36. Conclusions: The authors found evidence for better pain relief and improved expiratory muscle function in patients receiving low thoracic epidural analgesia compared with patient
Factors Associated with Revision Surgery after Internal Fixation of Hip Fractures
Background: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. Methods: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. Results: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25-2.50; P = 0.001], higher body mass index (fo
Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.
BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca
Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
Background
A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials.
Methods
This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674.
Findings
Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation.
Interpretation
ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials
Routine Complete Capsular Closure During Hip Arthroscopy
The utility of hip arthroscopy has recently progressed beyond diagnostic to therapeutic purposes addressing central and peripheral compartment pathologies. Capsulotomy provides freedom of visualization and instrumentation. The contribution to hip stability of both dynamic and static hip structures is not fully understood. However, both basic science biomechanical and clinical outcome studies have exhibited a relevant role of the capsule in hip stability. Though rare, iatrogenic post-arthroscopy subluxation and dislocation have been reported. Therefore many surgeons have cautioned against aggressive capsulotomy or capsulectomy without repair, because of the potential for precipitation of iatrogenic hip instability. We typically perform a “T” capsulotomy and recommend complete capsular closure in conjunction with labral repair and osseous femoral and acetabular treatment. A safe, efficient, and effective method to accomplish complete capsular closure is presented to reduce iatrogenic postoperative hip instability
Arthroscopic-Assisted Core Decompression for Osteonecrosis of the Femoral Head
The management of pre-collapse osteonecrosis of the femoral head is controversial. Core decompression is a technique that theoretically decreases the intraosseous pressure of the femoral head, resulting in a local vascularized healing response. Its efficacy has been shown in delaying early subchondral collapse. We describe the technique of arthroscopic-assisted core decompression of the femoral head for osteonecrosis. The advantages of this technique include evaluation of the presence or absence of articular cartilage injury, subchondral collapse, and guidance during reaming and curettage. It also allows the ability to address any concomitant soft-tissue or bony pathology associated with or in addition to the osteonecrotic lesion
Arthroscopic Bony Bankart Fixation Using a Modified Sugaya Technique
Arthroscopic fixation of bony Bankart lesions in the setting of anterior shoulder instability has had successful long-term results. Key factors such as patient positioning, portal placement, visualization, mobilization of bony/soft tissues, and anatomic reduction and fixation are crucial to yield such results. We present a modified Sugaya technique that is reproducible and based on such key principles. This technique facilitates ease of anchor and suture placement to allow for anatomic reduction and fixation
Arthroscopic Distal Tibial Allograft Augmentation for Posterior Shoulder Instability With Glenoid Bone Loss
Glenoid bone loss is commonly associated with recurrent shoulder instability. Failure to recognize and appropriately address it can lead to poor outcomes. Numerous studies have found anterior-inferior glenoid bone loss in the setting of recurrent anterior instability. Though much less common, posterior shoulder instability can be seen in the setting of acute trauma, epilepsy, electrocution, and alcoholism. Heightened awareness has led to recognition in collision athletes as well. Posterior glenoid bone loss must be addressed in a similar fashion to anterior glenoid bone loss to prevent recurrent instability. Open bone augmentation procedures have been described with successful results. In this technical note, we describe an arthroscopic technique using fresh distal tibial allograft for posterior glenoid augmentation. In addition, a current review regarding the diagnosis and management of recurrent posterior shoulder instability is provided
The Posterolateral Portal: Optimizing Anchor Placement and Labral Repair at the Inferior Glenoid
The Bankart lesion is considered the critical lesion in anterior shoulder instability, in which the anteroinferior glenoid labrum separates from the glenoid rim. Technical advances in arthroscopy have ushered in a shift from open to arthroscopic Bankart repair. When one is performing an arthroscopic Bankart repair, proper portal placement is critical for success in labral preparation and anchor placement. Frequently, standard anterior portals are insufficient for inferior glenoid anchor placement and suture shuttling. The posterolateral portal—located 4 cm lateral to the posterolateral corner of the acromion—simplifies and improves anchor placement, trajectory, and anatomic capsulolabral repair of the inferior glenoid. We present our preferred technique for capsulolabral repair of the inferior glenoid