Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Breast Neoplasms

Pain

Acute Pain

Neurologic Manifestations

Acute Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Analgesics

Platelet Aggregation Inhibitors

Antipyretics

Anesthetics

Fentanyl

Oxycodone

Rocuronium

Ropivacaine

Propofol

Sevoflurane

Succinylcholine

Acetaminophen

Analgesics, Non-Narcotic

Analgesics, Opioid

Narcotics

Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone.

After the induction of general anesthesia, before the beginning of the surgery, the erector spinae plane block with 0.375% ropivacaine will be performed. Then, the patient will be treated as in the controlled group.

After the induction of general anesthesia, before the beginning of the surgery, the erector spinae plane block with 0.9% saline will be performed. Then, the patient will be treated as in the controlled group.

Ultrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose).

Erector spinae plane block

Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).

Sham block

Standard general anesthesia. The induction with fentanyl, 1-3 mcg per KG; propofol, 1.5-2 mg per kg. Then, the laryngeal mask airway will be inserted. Patients with the risk of aspiration will be intubated using rocuronium or suxamethonium.

The maintenance with oxygen/air mixture, sevoflurane, and fentanyl.

General anesthesia

All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)

Patient-controlled analgesia

Intravenous oxycodone will be administered about 30 minutes before the end of the surgery at a dose of 0.1 mg/KG. Additional 2 doses can be given if pain on the visual analog scale will be higher than 40.

intravenous paracetamol will be used (1.0 gram), up to 4 grams per day

paracetamol

Paweł Piwowarczyk, MD-PhD

Patients scheduled for breast surgery due to cancer. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Patients will be allocated to one of three groups: erector spinae plane (ESP) block, sham block, controlled group.

Only patients who are qualified for an elective procedure of mitral breast surgery may participate in the study. Each patient will be anesthetized generally. The same drugs will be used in each stage of anesthesia. The induction: propofol, fentanyl, rocuronium. The airway will be secured with a laryngeal mask airway (LMA). When there is a risk of aspiration, the patient will be intubated. Then, rocuronium or suxamethonium will be used. The anesthesia maintenance: sevoflurane, fentanyl. The emergence: oxygen, sugammadex or neostigmine a required.

After the induction of general anesthesia, an opaque envelope with the selected group will be opened. In the controlled group, the procedure will be continued in the patient's supine position. Women from the ESP and Sham groups will be placed in the lateral position. The operated side will be above. Then, the ultrasound-guided ESP block with saline or ropivacaine will be performed.

At the end of the surgery, an anesthesiologist will administer oxycodone intravenously (0.1 mg/KG).

After emergence from anesthesia, the patient will be transferred to the postoperative care unit. Vital signs will be monitored. The patient-controlled analgesia pump with oxycodone will be used.

The patient: The primary intervention (erector spinae plane block) will be provided under general anesthesia.

The investigator and outcome assessor will be not aware of the allocation.

ESP in Breast Surgery Due to Cancer

Effectiveness of the Erector Spinae Plane Block in Patients Undergoing Breast Surgery Due to Cancer

Quality of recovery (QoR) score containing 40 items. This questionnaire measures the early postoperative health status of patients. Minimum is 40, maximum is 200. More points is better.

Acute pain measured with VAS (visual analog scale). From 0 (no pain) to 100. More on the scale is worse.

Consumption of oxycodone with PCA pump, loading, and additional doses.

Medical University of Lublin

associate professor

Mouth and Tooth Diseases

Digestive System Diseases

Carcinoma

Carcinoma, Squamous Cell

Headache

Head and Neck Neoplasms

Stomatitis

Mucositis

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Narcotic Antagonists

Buprenorphine

Tramadol

The main objective of this study is to provide preliminary evidence that FDA approved dose of transdermal buprenorphine in conjunction with oral tramadol can provide adequate analgesia of radiation-induced mucositis pain during treatment and follow up period in head and neck cancer patients.

Transdermal buprenorphine will be started at 5 mcg/hr once a week. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 20 mcg/hr once a week.

Oral tramadol will be started at 50 mg/day. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 400 mg/day.

Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.

Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.

Oral Mucositis (OM) Pain App

Stuart J. Wong, MD

This is a single-arm prospective clinical trial to determine the safety and feasibility of using transdermal buprenorphine in alleviation of radiation induced mucositis pain in head and neck cancer patients.

Hypothesis: Long-acting transdermal buprenorphine (FDA-approved dose from 5 mcg to 20 mcg /week) in conjunction with oral tramadol (50mg-400mg) as needed for breakthrough pain would lead to significant reduction in mucositis-related pain in locally advanced head and neck cancer patients being treated with radiation therapy by the end of treatment and follow up period of 12 weeks.

This is a single-arm, interventional, supportive care clinical trial for head and neck cancer patients evaluating role of transdermal (TD) buprenorphine and tramadol combination in alleviating radiation-induced mucositis pain. This will generate preliminary data to test the feasibility and efficacy of study drug regimen. The study will also test the clinical usefulness of the smart phone pain app in recording and reporting radiation induced mucositis pain.

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients: A Pilot Study

The Brief Pain Inventory - Short Form (BPI-sf) is a nine-item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity -- 0 being no pain and 10 being the pain as bad as you can imagine (within the previous 24 hours).

The Oral Mucositis (OM) Pain App is a smartphone application that was designed to permit subjects to key in pain severity using a visual analog 0-10 scale. The amount of pain that a subject feels ranges across a continuum from none (0) to an extreme amount of pain (10). The App is programed with an alarm to prompt the patient to record pain severity at prescribed intervals daily and through spontaneous patient input. Compliance is measured by subjects entering in a value four times a day into the OM Pain App.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ESP in Breast Surgery Due to Cancer	NCT04726878	Breast Cancer Pain, Acute Anesthesia, Loc...	Erector spinae ... Sham block General anesthe... Patient-control... Oxycodone paracetamol	18 Years - 80 Years	Medical University of Lublin
Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients	NCT04752384	Head and Neck S...	Buprenorphine Tramadol Oral Mucositis ...	18 Years - 80 Years	Medical College of Wisconsin
Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients	NCT04752384	Head and Neck S...	Buprenorphine Tramadol Oral Mucositis ...	18 Years - 80 Years	Medical College of Wisconsin

Spots Global Cancer Trial Database for visual analog scale