The pharmacokinetics of bupivacaine 0.5% with epinephrine 5 mcg/mL for a total dose of 2mg/kg of ideal body weight following an ESP block will be determined by the collection of blood samples at predetermined time points.

Pharmacokinetics

Anesthesia, Local

Nine blood samples will be collected to determine bupivacaine pharmacokinetics at T10min, T20min, T30min, T45min, T60min, T90min, T120min, T180min, and T240min. T0 will be defined as the end of bupivacaine injection.

Collection of blood samples

Centre Hospitalier de l'Université de Montréal (CHUM)

Peak Plasma Levels of Bupivacaine After an Erector Spinae Block (ESP)

Peak Plasma Levels of Bupivacaine After an Erector Spinae Block

The Cmax will be estimated by interpolation based on the plasmatic bupivacaine values obtained after the analysis of the blood samples.

The Tmax will be estimated by interpolation based on the plasmatic bupivacaine values obtained after the analysis of the blood samples.

Sensory block level will be measured with a 6.1g von Frey filaments.

The quality of postoperative analgesia at rest will be evaluated with a verbal numeric scale (VNS) where 0 represents 'no pain' and 10 represents 'the worst pain'.

The total dose of opioids used by the patients during the PACU stay will be recorded.

Centre hospitalier de l'Université de Montréal (CHUM)

patients were subjected to ultrasound guided SGB using 1 ml ketamine in a dose of 0.5mg/kg plus 5ml bupivacaine 0.5% in total volume 10 ml

patients were subjected to ultrasound guided SGB using 1 ml ketamine in a dose of 0.5mg/kg plus 5ml bupivacaine 0.5% in total volume 10 ml plus posterior approach shoulder injection with PRP.

Breast Neoplasms

combined platelet rich plasma and 1 ml ketamine in a dose of o.5 ml/kg plus 5ml bupivacaine 0.5% in a total volume 10 ml

Platelet rich plasma

1 ml ketamine in a dose of o.5 ml/kg plus 5ml bupivacaine 0.5% in a total volume 10 ml

ketamine and bupivacaine injection

Ultrasound Guided Stellate Ganglion Block in Postmastectomy Pain Syndrome: A Comparison of Ketamine versus Morphine as Adjuvant to Bupivacaine

Urbaniak GC, Plous S. Research randomizer. Retrieved July. 1997;7:2008.

Sweeny J, Grossman BJ. Blood collection, storage and component preparation methods. Tech Manual 14th ed Bethesda MD Am Assoc Blood Banks. 2002;955-8.

Welsh WJ. Autologous platelet gel: clinical function and usage in plastic surgery. Cosmet Derm. 2000;11:13.

MansouraU

Combined Intra-articular Shoulder Injection and Stellate Ganglion Block in Chronic Post-mastectomy Shoulder Pain

Combined Platelet Rich Plasma Intra-articular Shoulder Injection and Stellate Ganglion Block. A New Technique for Management of Chronic Post-mastectomy Shoulder Pain Syndrome

Visual analogue score (VAS) was done at rest and at shoulder movement before injection, one, two and three months after injection. VAS was explained to the patients during assessment as 0 equal no pain and 10 equal worst imaginable pain. Shoulder mobility was assessed while the patient was sitting using goniometry.

It was measured in degrees in five position (extension, flexion, and abduction, internal and external rotation) before and one month after injection.

shoulder and hand (DASH) questionnaire was done before injection, one, two and three months after injection.

Nevert Adel

Principal investigator

Mansoura University

Investigators were not allowed to know randomization codes and block size until all calculations and measurements had been entered into the database for all patients. All medical caregivers, investigators and patients were blinded to group allocation. One hour before the injection procedure of an enrolled patient, a nurse (not otherwise participating in the study) opened a sealed opaque envelope containing group allocation, and then filled the assigned drug injection for each patient according to the protocol of randomization.

This trial employs a phase I design with a dose escalation stage (stage I) and an expansion stage (stage 2) to better describe the tolerability of this combination and the effect of this combination on several biomarkers. In this second stage there will be two groups, each with ten patients, to better describe the tolerability of the bevacizumab/ABT-510 combination and the effect of this combination on several biomarkers. The primary objective of this study is to estimate the MTD/recommended phase II dose regimen. All other objectives are exploratory in nature.

Solid Tumors

Stage 1 (Cohorts -1, 2, 2, 3) ABT-510: 25, 50, 50, 100 mg SC BID*, bevacizumab: 5, 5, 10, 10 mg/kg IV every 14 days*
Stage 2 (RPTD) ABT-510: X mg SC BID**, bevacizumab: Y mg/kg IV every 14 days**
Stage I is the dose escalation stage. Stage II will include an additional 20 patients (10 patients in each group) enrolled at the RPTD in two different schedules to better assess safety and biomarker correlates.
*Both agents begin on Day 1 of Cycle 1.
**At the RPTD, ½ the patients will begin ABT-510 (Dose X) on Day 1 and bevacizumab (Dose Y) on Day 15 and the other ½ of the patients will begin bevacizumab on Day 1 and ABT-510 on Day 15. This will allow for a collection of some preliminary data of wound angiogenesis effects of ABT-510 alone versus the combination and bevacizumab alone versus the combination.

bevacizumab, ABT-510

Duke University Medical Center

A Phase I Study of ABT-510 in Combination With Bevacizumab in Advanced Solid Tumors

A Phase I Study of ABT-510 in Combination With Bevacizumab in Advanced Solid

Herbert Hurwitz

Associate Professor of Medicine

Genentech, Inc.

Abbott

Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.

Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.

Intraductal Arm

Intravenous Arm

Total

Sex: Female, Male

Region of Enrollment

Maximum tolerated dose (MTD) of administering pegylated liposomal doxorubicin (PLD) into one duct of women with breast cancer awaiting mastectomy. MTD reflects highest dose of drug that did not cause Dose Limiting Toxicity (DLT) in more than 30% of patients.

Maximum Tolerated Dose (MTD)

Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in blood (plasma) across all the participants in each group is reported.

Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.

Intraductal Arm- 0 mg PLD

Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.

Intraductal Arm- 2 mg PLD

Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.

Intraductal Arm- 5 mg PLD

Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.

Intraductal Arm- 10 mg PLD

Concentrations of Doxorubicin in Blood (Plasma) at Definitive Surgery

Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in tissue across all the participants in each group is reported.

Concentrations of Doxorubicin in Tissue at Definitive Surgery

Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.

Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.

Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.

Overall Study

Dr. Vered Stearns

Note: Adverse events were not collected in the intravenous group/arm; only the concentration of doxorubicin in tissue applied to this group of participants.

Breast Cancer

Patients will receive PLD intraductally according to the dose escalation schema (Dose Level -1=1 mg, Dose Level 1=2 mg, Dose Level 2= 5mg, Dose Level 3=10 mg). The PLD dose will be diluted in 5% dextrose in water and will be mixed for a total volume of 5 ml. The PLD will be administered via a breast duct (i.e., intraductally) using a microcatheter

Intraductal arm

Blood samples and a breast tissue biopsy collected to look at levels of doxorubincol from patients receiving intravenous pegylated liposomal doxorubin to compare to the group receiving drug intraductally.

Intravenous arm

Indiana University Melvin and Bren Simon Cancer Center

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer

A Phase I Study Assessing the Feasibility and Safety of Intraductal Administration of Pegylated Liposomal Doxorubicin (Doxil) in Women With Breast Cancer

dextrose/breast neoplasms

Peak Plasma Levels of Bupivacaine After an Erector Spinae Block (ESP)

Combined Intra-articular Shoulder Injection and Stellate Ganglion Block in Chronic Post-mastectomy Shoulder Pain

A Phase I Study of ABT-510 in Combination With Bevacizumab in Advanced Solid Tumors

Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer

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