Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Flushing

Hot Flashes

Ganglion Cysts

Synovial Cyst

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Central Nervous System Depressants

Pharmaceutical Solutions

Tamoxifen

Bupivacaine

Estrogens

Estrogen Receptor Modulators

Aromatase Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Anesthetics

Anesthetics, Local

Stellate Ganglion Block injection with 10 mL .5 % bupivacaine.

Saline injection (.9 normal saline) 5 ml.

A computer-generated 1:1 block randomization scheme will be used to assign participants to receive bupivacaine. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.10 mL .5% bupivicaine will be administered.

Bupivicaine

A computer-generated 1:1 block randomization scheme will be used to assign participants to receive saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card. 5 mL sterile normal saline will be administered.

Saline

David R. Walega, MD, MSCI

Vasomotor symptoms (VMS) affect up to 65% of breast cancer survivors and negatively impact their quality of life. The investigators aim to evaluate the benefit of SGB in symptomatic women with breast cancer who are on anti-estrogens and are seeking relief from moderate to very severe VMS that are adversely affecting health and wellbeing. Women with breast cancer on Tamoxifen, aromatase inhibitors (AIs) or Selective Estrogen Receptor Modulators (SERMS) with moderate to very severe VMS will be enrolled as participants in this study.

Hypotheses: The frequency and intensity of subjective and objective VMS will be significantly lower in women randomized to active SGB as compared to sham controls. Mood, memory, cognition, sleep, and quality of life will all be improved in the treatment group as compared to the sham-control group.

Specific Goals and Objectives:

Goal 1: To determine the effect of stellate ganglion blockade (SGB) for reducing subjective and objective VMS in women with breast cancer on tamoxifen, AIs, or SERMs Goal 2: To evaluate the effect of SGB on mood, memory, cognition, sleep and quality of life in women with breast cancer on tamoxifen, AIs, or SERMs.

We aim to conduct a randomized, single-site, sham-control clinical trial of SGB on VMS in 30 women with breast cancer on anti-estrogen therapy (15 per group). The primary entry criterion will be 28 or more moderate to very severe hot flashes per week. VMS will be measured by self-report on a written daily dairy over a 6-month period. Secondary outcomes include changes in mood, sleep, quality of life, and objective hot flashes measured by ambulatory monitoring (skin-conductance temperature monitoring) for 24 hours at baseline, three months and six months. Memory performance with neurocognitive testing will be done at baseline and 3 months.

Stellate Ganglion Block (SGB) For Women for Breast Cancer

Effects of Stellate Ganglion Block (SGB) on Vasomotor Symptoms in Women Receiving Anti-Estrogen Therapy for Breast Cancer

Change in number of mean night sweats from baseline to 6 months after intervention using a paper diary (subjective measure of frequency). Number is the change from mean baseline number of night sweats to mean 6 months after procedure (number of ns/month)

Mean change in number of hot flashes from baseline to 6 months after intervention using a paper diary (subjective measure of frequency). Number is the change from mean baseline number of hot flashes to mean 6 months after procedure (number of ns/month)

Hot flashes intensity from baseline and at 6 months as reported by the subject using paper diary (subjective) measures of intensity (including mild, severe and very severe HF).Intensity scoring = Frequency\*Severity = \[(frequency of mild\*1)+(frequency of moderate\*2) + (frequency of severe\*3) + (frequency of very severe\*4)\].

Mean intensity of hot flashes at baseline and 6 months. Score on a unlimited scale of 0- infinity based on number of hot flashes. A score on the scale where 0 is good higher scores are worse.

Baseline score change compared to the 6 month survey score using the Epidemiological Studies-Depression(CES-D) survey. This survey is a 20-item measure that asks to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. CES-D also provides cutoff scores (e.g., 16 or greater) that aid in identifying individuals at risk for clinical depression

Change in Pittsburg Sleep Quality Inventory (PSQI) between baseline and 6 months post intervention. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

University of Illinois at Chicago

Northwestern University

Associate Professor of Anesthesiology; Chief,Section of Pain Medicine

Adverse events are collected up to 7 days after the stellate ganglion block procedure.

Stellate Ganglion Block injection with bupivacaine

Bupivicaine: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive bupivacaine. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.

Saline injection

Saline: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Body Mass Index (kg/m^2)

Number of participants who have undergone a surgical procedure resulting in menopause.

Surgical menopause

Post menopausal

CES D is a 20 question survey where each question is scored 0-3 for a possible score of 0 low possibility of depression to 60. A score of 16 on the survey indicates a possibility of depression.

CES D Depressive Symptoms

The PSQI is a 7 component survey which is scored on a likert scale of 0 no disfunction to 3 great disfunction. A score of 0-21 is possible. A score of 21 would indicate worst sleep quality.

Pittsburgh Sleep Quality Index (PSQI)

The Functional Assessment of Cancer is a 37 item questionnaire scored using a likert scale of 0 (not at all) - to 4 (very much). The score ranges from 0 (poor) to 123 (good).

Functional Assessment of Cancer (FACT-B

Vasomotor symptoms (hot flashes) number per day as recorded by the participant using a daily diary.

Vasomotor Symptoms (Hot Flash)

Objective vasomotor hot flashes per day identified using a monitor attached non-invasively to paticipants skin.

Objective vasomotor symptoms (Hot Flashes)

Intensity of hot flashes reported by the participant in a daily diary. Scored on a scale of 0- no intensity to 100 greatest intensity.

Intensity of hot flashes (diary)

Number of subjects who consented and randomized to treatment.

Paul Fitzgerald

3 subjects in the bupivicaine group data was not available, 2 subjects in the saline treatment group data was not available.

Change in Number of Night Sweats From Baseline to 6 Months After Intervention.

Stellate Ganglion Block injection with 10 mL .5 % bupivacaine.

Bupivicaine: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive bupivacaine. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.10 mL .5% bupivicaine will be administered.

Saline injection (.9 normal saline) 5 ml.

Saline: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card. 5 mL sterile normal saline will be administered.

2 in the bupivicaine and 1 in the saline group at 6 months did not respond to interview.

Change in Number of Hot Flashes From Baseline to 6 Months After Intervention. [Time Frame: 6 Months After Intervention]

Hot Flash Intensity Baseline

Hot Flash Intensity 6 Months

10 subjects in the bupivicane group data not obtained and 4 subjects in the saline group not obtained at six months.

Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months

5 subjects in the bupivicaine group and 2 subjects in the saline group data not available.

Survey Score Changes From Baseline to 6 Months After Intervention Using the Epidemiological Studies-Depression(CES-D) Survey.

5 subjects in the bupivicaine group and 2 subject in the saline group data was not available.

Changes From Baseline of Pittsburg Sleep Quality Inventory (PSQI)

Stellate Ganglion Block injection with bupivacaine

Bupivicaine: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive bupivacaine. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card. 10mL of 0.5% bupivicaine will be administered.

Saline injection

Saline: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card. 5 mL of sterile normal saline will be administered.

Overall Study

Nervous System Diseases

Rare Diseases

Syndrome

Chronic Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Anti-Arrhythmia Agents

Channel Blockers

Analgesics

Anticonvulsants

Reproductive Control Agents

Magnesium Sulfate

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Tocolytic Agents

The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.

The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml

assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy

magnesium sulphate

bupivicaine

Rehab A. Abd Elaziz, Ass. Prof.

Rehab A. Abd Elaziz, Ass.Prof.

Modified radical mastectomy may be associated with severe post-operative pain, leading to chronic pain syndrome which usually requires optimal perioperative pain management.

Patients will be randomly into two equal groups (40 patients each) according to the adjuvant added to the local anesthetic (bupivacaine) in the serratus anterior plane block using a computer-generated random numbers concealed in sealed opaque envelopes. Group B: The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml. Group BM: The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.

Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy

Effectiveness of Adding Magnesium Sulphate to Bupivicaine in Ultrasound Guided Serratus Anterior Plane Block in Patients Undergoing Modified Radical Mastectomy

Alexandria University

Assisstant Professor of Anesthesia

Pain, Postoperative

Postoperative Complications

Vasoconstrictor Agents

Respiratory System Agents

Epinephrine

Racepinephrine

Epinephryl borate

TAP block with bupivicaine/epinephrine placed prior to surgery.

TAP block with placebo placed prior to surgery

The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis

The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.

Placebo

David M Kushner, MD

This study is a single-center, randomized, placebo-controlled, double-blind clinical trial. The purpose of this study is to evaluate the impact of pre-operative transverses abdominis plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for gynecologic cancers.

Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery: A Prospective Randomized, Double-blind, Placebo-controlled Trial

Pain scores by the Visual Analog Scale (VAS) \[0-5, where 0 is no pain and 5 is extreme\] and Wisconsin Brief Pain Inventory (BPI) \[where 0 is no pain and 10 is the most painful\], will be collected 3 times post-operatively (once the day of surgery (at least 2 hours post-op) and both the morning and afternoon/evening on post-operative day #1). Pain scores will be analyzed individually using the chi-squared test and linear regression. All statistical calculations used a two-sided significance level of 0.05 and were calculated using the R Project for Statistical Computing. VAS and BPI scores for each subject were averaged to provide a resultant VAS and BPI score.

University of Wisconsin, Madison

TAP block with bupivicaine/epinephrine placed prior to surgery.

Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis

TAP block with placebo placed prior to surgery

Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.

Body Mass Index (BMI)

The treatment group, who received TAP block placement, was younger than the saline injection group, on average (55.2 versus 62.1, P = 0.028).

Unilateral placement of block may decrease overall effectiveness. Sample size was small, from single institution, and encompassed a variety of diagnoses and procedures. Analysis also included intraoperative medications.

Dr. David Kushner

24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents

Pain Scores

Breast Diseases

Skin Diseases

On-Q Pain Pump filled with Saline. The On-Q pump will be connected to the catheter to deliver a constant flow of saline for up to 5 days.

On-Q Pain Pump filled with 0.375% Bupivicaine through two catheters at a total rate of 4 cc/hr over 111 hours. The On-Q pump will be connected to the catheter to deliver a constant flow of Bupivicaine for up to 5 days.

Charles E. Butler, MD

The objective of this pilot study is to examine the efficacy of the ON\~Q Pain Relief System plus Intravenous Patient Controlled Analgesia (IVPCA) with Morphine vs IV PCA alone in patients undergoing free transverse rectus abdominis musculocutaneous (TRAM) flap surgery. The primary outcome measure will be postoperative opioid analgesia requirements. Other outcomes will also be assessed, including pain scores, quality of recovery, and resource utilization.

Inadequate control of surgical pain after free TRAM procedures may lead to complications and delay recovery time. This could lead to a longer stay in the hospital. The standard care for pain after a free TRAM procedure has been with drugs that are anesthetics. Unfortunately, these anesthetics are not long lasting and usually require the use of opioids (morphine or hydromorphone) to control "break-through" pain. A continuous delivery of local anesthetic to the wound site may provide better control of pain and decrease the need for the use of opioids. This may decrease the length of the hospital stay as well as other side effects associated with the treatment of pain.

Before the study, you will be asked questions about your health, your age, and about any allergies you may have. Women who are able to have children must have a negative blood pregnancy test. You will have already been scheduled to undergo a free TRAM flap procedure.

During free TRAM flap procedure, you will have two "soaker catheters" placed by the surgeon directly into the surgical site. The catheters are flexible tubes which will allow pain medicine (or saline) to be delivered directly to the donor wound site which is the abdominal site from where the tissue for breast reconstruction is taken. A small pump (On-Q pump) will be connected to the catheter to deliver a constant flow of pain medicine (or saline) for up to 5 days. The On-Q pump is completely portable and can be attached to your hospital gown to allow for movement.

You will be randomly assigned (as in the toss of a coin) to one of two groups. Participants in the first group will have the On-Q pump filled with saline. Participants in the other group will have the On-Q pump filled with bupivicaine.

Participants in both groups will receive IVPCA, which is the standard of care for pain relief. The IVPCA will be placed on PRN mode which means you will be able to press a button to deliver pain medication whenever you feel pain.

You will be asked questions about your pain and your recovery process every 6 hours while you are awake for up to 5 days. You will also be asked to fill out a questionnaire about pain once a day during treatment. It should take around 10 minutes to complete the questionnaire.

The catheters will be removed after 5 days of treatment (or your last day in the hospital, whichever is sooner) by one of the surgeons that participated in the surgery

During the study, if you experience any intolerable side effects or your doctor feels it is in your best interest to stop treatment, you will be taken off the study and other treatment options will be discussed with you.

This is an investigational study. The On-Q device, PCA, and bupivicaine are FDA approved and commercially available. Up to 60 participants will take part in this study (30 in each group). All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center (MDACC).

This protocol is partially funded by a research grant from the I-Flow Corporation.

Pain Management Following TRAM Flap for Breast Reconstruction

Randomized, Double Blind, Controlled Trial of Two Methods of Postoperative Pain Management Following Free Transverse Rectus Abdominous Musculocutaneous (TRAM) Flap for Breast Reconstruction

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stellate Ganglion Block (SGB) For Women for Breast Cancer	NCT02513329	Hot Flushes Hot Flashes	Bupivicaine Saline	30 Years - 70 Years	Northwestern University
Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy	NCT04429893	Cancer Breast Chronic Pain Sy...	magnesium sulph... bupivicaine	20 Years - 70 Years	Alexandria University
Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy	NCT04429893	Cancer Breast Chronic Pain Sy...	magnesium sulph... bupivicaine	20 Years - 70 Years	Alexandria University
Stellate Ganglion Block (SGB) For Women for Breast Cancer	NCT02513329	Hot Flushes Hot Flashes	Bupivicaine Saline	30 Years - 70 Years	Northwestern University
Stellate Ganglion Block (SGB) For Women for Breast Cancer	NCT02513329	Hot Flushes Hot Flashes	Bupivicaine Saline	30 Years - 70 Years	Northwestern University
Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery	NCT01444924	Gynecologic Can... Post-operative ...	Bupivicaine Placebo	18 Years -	University of Wisconsin, Madison
Pain Management Following TRAM Flap for Breast Reconstruction	NCT00500565	Breast Cancer	Saline Bupivicaine	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for bupivicaine

Every month we try and update this database with for bupivicaine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bupivicaine

Every month we try and update this database with for bupivicaine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bupivicaine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.