Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Respiratory Insufficiency

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Respiration Disorders

Respiratory Tract Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Bupivacaine

After endotracheal intubation, patients will be positioned in lateral decubitus position. A linear ultrasound probe will be placed at the edge of scapula at the level of T5-T6. Under sterile conditions, the landmark points (rhomboid major muscle, 5th and 6th ribs, and intercostal muscles) will be observed and a block needle will be directed to the interfacial plane between rhomboid major muscle and intercostal muscle. RIB will be performed by injecting 20 ml of bupivacaine 0.25%. In the same position, the probe will be placed at the midaxillary line at the level of T3, and the landmark points (latissimus dorsi muscle and serratus muscle and intercostal muscles) will be observed. Under sterile conditions, a SAP block will be performed by injecting 20 ml of Bupivacaine 0.25% into the plane between serratus muscle and intercostal muscle.

No block procedures will be performed in this group.

RIB block will be performed after endotracheal intubation, then a SAP block will be performed. No other intervention will be performed to the patients.

RIB+SAP blocks

Bakiye Uğur, MD

Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. Serratus anterior plane block is used to block lateral cutaneous branches of intercostal nerves between T2 and T6, in addition, it is also known to block thoracodorsal nerve and long thoracic nerve. Both of the blocks are usually performed for postoperative analgesia following breast surgery. The primary hypothesis of the study is that FEV1 value of the patients who will receive modified radical mastectomy (MRM) and rhomboid intercostal plane (RIP) block combined with serratus anterior plane (SAP) will be higher than FEV1 value of the patients in the no-block group. The secondary hypothesis is that RIP+SAP blocks will provide reduction in the pain scores and opioid consumption in the postoperative first 24 hours.

The patients who are scheduled for MRM under general anesthesia, aged between 18-65 years and ASA scores I-II will be included in the study. Respiratory functions (FEV₁, FVC, FEV₁/FVC, PEF, FEF25-75) of the patients will be measured by a hand-held spirometry device prior to the operation in the surgical ward. The induction of anesthesia will be provided similarly in all patients, then patients will be intubated and randomly divided into two groups. One group will receive RIP+SAP block using 40 milliliters of %0.25 bupivacaine and patients in the control group will receive no block procedures. The standard analgesia will be provided by intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg which will be administered in 15 minutes before end of the surgery. Respiratory functions of the patients will be measured at the postoperative 2nd, 4th and 24th hours. Pain intensity of the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges between 0 (no pain) and 10 (the worst pain that a person can stand). NRS scores will be evaluated at the postoperative 15th, 30th minutes and 1st, 2nd, 6th, 12th and 24th hours, and opioid consumption will be recorded at the postoperative 24th hour.

Prospective, randomized, controlled study

The patients will be under general anesthesia and will not know if they received a block procedure or not.

The investigator, the data collector and the outcome assessor will be completely blind to the study groups. Only the care provider who will perform the block procedures will know the study groups.

The Effect of Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions

The Effect of Ultrasound-guided Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions and Analgesia After Breast Surgery

FEV1 of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

The pain scores of the patients in the block group will be lower than the patients in the control group at the postoperative second hour.

The opioid consumption of the patients in the block group will be lower than the patients in the control group at the postoperative 24th hour.

FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

FEV1/FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

FEF25-75 values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

PEF values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

Muğla Sıtkı Koçman University

Associated Prof Dr

Gland and Hormone Related Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Recurrence

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

Patients who have been successfully operated on with total parathyroidectomy for symptomatic secondary hyperparathyroidism and their PTH levels are below 72 pg/dL within one week after surgery.

Patients who have had regular dialysis and their iPTH levels are around 500 pg/dL

Patients should receive total parathyroidectomy plus bilateral thymectomy and autotransplantation

parathyroidectomy plus bilateral thymectomy and autotransplantation

Chang Huang-Chih, MD

Chen Jib-Bor, MD

Lai Chi-Chih, MD

In this study, investigators measure patient's voice frequency, swallowing function, and O2 desaturation of the 6 mins walking test before surgery and 4 months after surgery, to find the increase of voice frequency, and swallowing function and the decrease of O2 desaturation.

This was a prospective case-control study. From July 2017 to Dec. 2018, investigators recruited 38 patients, who had undergone a successful operation of total parathyroidectomy and bilateral thymectomy (TPxBT) plus autotransplantation for symptomatic secondary hyperparathyroidism as the study group. In the same period 4 patients who had a surgical failure were excluded from the study. Indications for surgery were patients who had undergone long-term regular hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), with serum levels of Ca \> 10.1 mg/dL, P \> 5.5 mg/dL, alkaline phosphatase (Alk-ptase) \> 94 U/L and intact parathyroid hormone(iPTH) \> 800 pg/mL and with symptoms and signs such as skin itching, bone pain, general weakness, insomnia and T-score of bone mineral density (BMD) (the lowest T-score of lumbar spine 1-4, global femur, femoral neck, radial 1/3, and global radius) \< -2.5. During surgery, Total parathyroidectomy and bilateral thymectomy was performed plus autotranplantation of 100 mg of hyperplastic parathyroid tissue to the subcutaneous tissue of the forearm without harboring an arteriovenous fistula.

Ten patients with regular hemodialysis who had developed mild secondary hyperparathyroidism (iPTH around 500 pg/mL) but did not undergo parathyroidectomy were recruited as the control group.

Investigators recorded patients' age, symptoms, gender, body mass index (BMI) and measured serum levels of Ca, P, Alk-ptase and iPTH, and BMD (T-score). The Investigators also recorded patients' voice quality, airway invasion during swallowing and pulmonary functions before surgery and 4 months after surgery to find the changes after surgery. In the control group, investigators recorded and measured these items at baseline and 4 months later.

At 1 week after surgery, serum Ca, P, Alk-ptase and iPTH levels were measured again to make sure that the operation was successful. A successful operation was defined as iPTH levels \< 72 pg/mL within 1 week after surgery. Four patients were excluded from this study with a surgical failure in the same period.

The perceptual evaluation of voice quality such as speech impairment and speech quality by means of multidimensional clinical measurements based on auditory methods with grade, hoarseness, roughness, breathiness, asthenia, and strain (GRBAS) on a scale (0-3) (normal-high degree) were performed by the ear, nose, and throat specialist (Dr. Lai, C.C.). Voice handicap index (VHI-10) (\>11, abnormal) and eating assessment tool (EAT-10) (≥ 3, abnormal) were evaluated by patients themselves.

Acoustic and aerodynamic measurements were applied to recordings of each subject producing sustained vowel productions in a soundproof room. Acoustic variables including jitter (Jitt), shimmer (ShdB), noise-to-harmonic ratio (NHR), fundamental frequency (Fo), and high pitch were measured using computerized speech laboratory (Core Model SCL # 4300B, KayPENTAX Elementries, Lincoln park, NJ).

The maximal phonation time and s/z ratio were measured with circumferentially vented pneumotachography mask and differential transducers of the Aerophone system (Aerophone II, Model 6800, KayPENTAX Elementrics). Vocal cord mobility, vocal cord closure (complete or incomplete), airway invasion during swallowing were inspected with fiber-optic endoscopy to show premature spillage, penetration-aspiration scale levels (1-8) (no entry of material into the larynx or trachea-material enter the airway passes below vocal folds and no effort is made to eject) (\>1, abnormal). The Yale pharyngeal residue severity rating scale for vallecula (0-4) (non-trace-mild-moderate-severe) and pyriform sinus (0-4) were also performed by the ENT specialist.

The specialist of chest medicine (Dr. Chang, H.C.) performed pulmonary function tests including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), bronchodilator test (BDT) (a positive response to BDT defined by the American Thoracic Society as an increase in FEV1 or FVC ≥ 12% and 200 ml), total lung capacity (TLC), and alveolar volume (VA) using MasterScope (Jaeger, VIASYS healthcare GmbH, Höchberg, Germany), and diffusion capacity of the lung for carbon monoxide (DLCO) using Vmax Autobox (SensorMedics, a subsidiary of VIASYS healthcare, California, USA). The 6 minutes walking test (6MWT) was also performed to evaluate distance (meter) and O2 desaturation (differences of O2 saturation between pre- and post-tests) (defined as positive if O2 desaturation ≧ 4%).

Pulmonary Function, Voice and Swallowing Symptoms After Parathyroidectomy

Changes of Pulmonary Function, Voice and Swallowing Symptoms After Total Parathyroidectomy for Secondary Hyperparathyroidism in the Presence of Intact Recurrent Laryngeal Nerve

After successful surgery, patients were recruited in the study, and we excluded patients with a surgical failure.

speech impairment and speech quality were evaluated with GRBAS on a scale (0-3), VHI-10 (\>11, abnormal) and (EAT-10) (≥ 3, abnormal) .

\*GRBAS (grade, roughness, breathiness, asthenia, strain) scale grades hoarseness, roughness, breathiness, aesthenia (weakness), and strain on a scale of 0-3 0 = normal, 1 = mild degree, 2 = moderate degree, and 3 = high degree

speech impairment and speech quality were evaluated with voice handicap index (VHI-10) (\>11, abnormal) 0-4 Rating Scale 0 = Normal

1. = Almost Normal
2. = Sometimes
3. = Abnormal
4. = Always

speech impairment and speech quality were evaluated with EAT-10 (≥ 3, abnormal) .

\*eating assessment tool (EAT-10) 0 - 4 Rating Scale 0 = No problem

1. = Mild Problem
2. = Mild to moderate
3. = Moderate problem
4. = Severe problem

mean frequency (F0, Hz); Noise-to-Harmonic Ratio (NHR), jitter(%), and shimmer (%)

The maximal phonation time (sec) and s/z ratio were measured with circumferentially vented pneumotachography mask and differential transducers of the Aerophone system .

Vocal cord mobility, vocal cord closure (complete or incomplete), airway invasion during swallowing were inspected with fiber-optic endoscopy to show premature spillage, penetration-aspiration scale levels . The Yale pharyngeal residue severity rating scale for vallecula and pyriform sinus (0-4) (non-trace-mild-moderate-severe) and pyriform sinus (0-4) were also performed.

Forced vital capacity (FVC) (L), forced expiratory volume in 1 second (FEV1), bronchodilator test (BDT) (a positive response to BDT defined by the American Thoracic Society as an increase in FEV1 or FVC ≥ 12% and 200 ml), total lung capacity (TLC) (L), and alveolar volume (VA) using MasterScope (Jaeger, VIASYS healthcare GmbH, Höchberg, Germany), and diffusion capacity of the lung for carbon monoxide (DLCO) (%) using Vmax Autobox (SensorMedics, a subsidiary of VIASYS healthcare, California, USA).

The 6 minutes walking test (6MWT) was also performed to evaluate distance (meter) and O2 desaturation (differences of O2 saturation between pre- and post-tests) (defined as positive if O2 desaturation ≧ 4%).

Chang Gung Memorial Hospital

Consultant professor

Immune System Diseases

Blood and Lymph Conditions

Hematologic Diseases

Workers and volunteers engaged or potentially engaged in oil spill clean-up operations in the Gulf of Mexico

Dale Sandler, Ph.D.

Background:

* There has been little research on the long-term health effects from oil spills, even though at least 10 percent of all oil tanker spills between 1970 and 2009 have affected coastal populations. The Deepwater Horizon disaster, with its release of approximately 5 million barrels (\~680,000 tons) of crude oil into the Gulf of Mexico, is far larger than any of the individual tanker spills. Given the magnitude of this spill and the scope of the potential exposures, including the 55,000 workers involved in clean-up efforts and countless residents of the affected areas, researchers are interested in monitoring Gulf clean-up workers to understand the adverse consequences of oil spills in general.
* The Gulf Long-term Follow-up Study will investigate health effects associated with the clean-up activities following the Deepwater Horizon disaster in the Gulf of Mexico on April 20, 2010. More than 100,000 persons completed safety training in preparation for participation in clean-up activities related to the spill. Many of these individuals participated in active clean-up efforts, but others did not. Exposures among persons involved in clean-up range from negligible to potentially significant, especially for workers involved in tasks associated with direct exposure to crude or burning oil, or to chemical dispersants. However, prediction of adverse health effects is not possible because the long-term human health consequences of oil spills are largely unknown. In addition to the oil itself, the widespread economic and lifestyle disruption caused by the oil spill may contribute to mental health problems among this population.

Objectives:

- To investigate potential short- and long-term health effects associated with clean-up activities and exposures surrounding the Deepwater Horizon oil spill.

Eligibility:

- English-, Spanish-, and Vietnamese-speaking workers and volunteers at least 21 years of age engaged or potentially engaged in oil spill clean-up operations in the Gulf of Mexico, or who lived in affected areas (Louisiana, Mississippi, Alabama, and Florida coastal regions).

Design:

* Participants will be divided into groups of those who performed oil-spill clean-up-related work ( exposed ) and those who did not engage in clean-up-related work ( unexposed controls).
* Participants will be screened with a full medical history and physical examination, as well as an interview to determine the nature of their potential exposure.
* Participants will provide blood, hair, toenail, urine, and saliva (spit) samples. Participants may also have a lung function exam.
* Participants will have researchers collect dust from their homes by using wipes and special vacuum bags.
* Participants will also provide detailed contact information, including their Social Security number, to be contacted in the future for long-term health follow-up appointments. These appointments will include 30-minute telephone interviews every 2 years.

The Gulf Long-term Follow-up Study (GuLF STUDY) will investigate potential short- and long-term health effects associated with the clean-up activities following the Deepwater Horizon disaster in the Gulf of Mexico on April 20, 2010. Crude oil, burning oil, and the dispersants used during clean-up efforts contain a range of known and suspected toxins. Over 100,000 persons have completed safety training in preparation for participation in clean-up activities related to the spill. While many of these individuals participated in active clean-up efforts, others did not. Exposures among persons involved in clean-up range from negligible to potentially significant, especially for workers involved in tasks associated with direct exposure to crude or burning oil, or to chemical dispersants. However, prediction of adverse health effects is not possible because the long-term human health consequences of oil spills are largely unknown due to the dearth of research in this area. The potential health effects associated with the levels of exposure experienced by clean-up workers are largely unstudied. Heat and stress experienced by these workers may also have adverse long-term health effects. In addition to the oil itself, the widespread economic and lifestyle disruption caused by the oil spill may contribute to mental health problems among this population.

The over-arching hypotheses of this study are:

1. Exposure to constituents of oil, dispersants, and oil-dispersant mixtures, and to spill-related stress by workers engaged in clean-up of the Deepwater Horizon oil spill are associated with adverse health effects, particularly respiratory, neurological, hematologic, and psychological or mental health.
2. There are exposure-response relationships between the above exposures and health effects.
3. Biomarkers of potentially adverse biologic effects are associated with the above exposures.

Based on what is known about individuals involved in clean-up efforts, the cohort will consist primarily of English-, Spanish-, or Vietnamese-speaking adults who performed oil-spill clean-up-related work ( exposed ) and similar persons who did not engage in clean-up-related work ( unexposed controls). Accommodations for enrolling participants speaking other languages will be developed through community collaborations as appropriate. Workers will be sampled from across job/potential exposure groups. A total of approximately 55,000 persons are expected to be enrolled into the cohort. A random sample of the full cohort, stratified by category of job/potential exposure (including N\~6,000 with no oil-spill work to serve as controls) and oversampled for workers with higher potential exposures, will be enrolled into an Active Follow-up Sub-cohort (N\~20,000). A random sample of the Active Follow-up Sub-cohort, also stratified by category of job/potential exposure and oversampled for workers with higher potential exposures, will be enrolled into a Biomedical Surveillance Sub-cohort (N\~5,000). Participants will be interviewed about their clean-up-related tasks, demographic and socioeconomic factors, occupational and health histories, psychosocial factors, and physical and mental health. Members of the Active Follow-up Sub-cohort will also be asked to provide biological samples (blood, urine, hair, toenail clippings, and possibly saliva) and environmental samples (house dust) and will have basic clinical measurements (height, weight, waist and hip circumference, blood pressure, urinary glucose levels, FEV1 and FVC as a measure of pulmonary function) taken during home visits at baseline. The Biomedical Surveillance Sub-cohort will participate in a more comprehensive clinical assessment after the initial home visit, including more comprehensive pulmonary function testing, neurological testing, and collection of additional biological and environmental samples. The specific tests to be performed and clinical protocols will be developed in collaboration with extramural investigators selected through a request for proposals (RFP). When developed, the protocol for this portion of the study will be submitted separately to the Institutional Review Board as a study amendment.

Exposures will be estimated using detailed job-exposure matrices developed from data from monitoring performed by different agencies and organizations during the crisis, as well as information on recommended or actual use of personal protection, information obtained by interview, and the available scientific literature. It should be noted that, in the absence of individual or group monitoring data for most workers, estimates of exposure, whether based on job activities or on more refined job-exposure matrices, will indicate the degree of potential exposure (i.e., exposure opportunity) rather than known exposure. We will investigate acute health effects via self-report from the enrollment interview among all cohort members and also via clinical measures and biological samples from Active Follow-up Sub-cohort members. All cohort members will be followed for development of a range of health outcomes through record linkage (cancer, mortality) and if feasible, through linkage with electronic medical records that may become available during the course of follow-up. Health outcomes among the Active Follow-up Sub-cohort will also be identified through self-report via periodic follow-up interviews. Additional outcome information will be obtained on the Biomedical Surveillance Sub-cohort from periodic follow-up clinical evaluations (e.g., spirometry, neurological testing) and analysis of follow-up biospecimens (e.g., immunologic parameters, liver function, renal function, DNA damage). Follow-up of the entire cohort is initially planned for 10 years, with extended follow-up possible depending upon scientific and public health needs and the availability of funds.

Recruitment of subjects should begin in March 2011, with the telephone interviews expected to be completed within 12-24 months and the baseline home visits within 18-26 months. For the home visits, we will initially target workers residing in the four most affected Gulf States (LA, MS, AL, and FL), although we may expand to other states if further information about the geographic distribution of workers and their potential exposures warrants additional follow-up in these states. We will work closely with a Community Advisory Board to develop community support for this study and appropriate communications and study materials.

Gulf Long-Term Follow-Up Study

Gulf STUDY: Gulf Long-Term Follow-Up Study

To investigate potential short- and long-term health effects associated with oil spill clean-up activities/exposures surrounding the Deepwater Horizon Disaster.

To investigate biomarkers of potentially adverse biological effect in relation to oil spill clean-up activities/exposures.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions	NCT05547932	Breast Cancer Postoperative P... Respiratory Fun...	RIB+SAP blocks	18 Years - 65 Years	Muğla Sıtkı Koçman University
Pulmonary Function, Voice and Swallowing Symptoms After Parathyroidectomy	NCT04267965	Secondary Hyper...	parathyroidecto...	20 Years - 80 Years	Chang Gung Memorial Hospital
Gulf Long-Term Follow-Up Study	NCT01287000	Cardiovascular ... Hematologic Dis... Immunologic Dis... Cancer Respiratory Fun...		21 Years -	National Institutes of Health Clinical Center (CC)

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