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Mastectomy clinical trials

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NCT ID: NCT03578237 Completed - Knee Arthropathy Clinical Trials

Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study

Start date: August 25, 2018
Phase: N/A
Study type: Interventional

The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this analgesic modality decreases the risk of persistent postoperative pain, or "chronic" pain. The objective of the proposed pilot study is to optimize the protocol and collect data to power subsequent, definitive clinical trials. Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of cryoanalgesia decreases the incidence and severity of post-surgical pain. Hypothesis 1a (primary): The severity of surgically-related pain will be significantly decreased on postoperative day 2 with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Hypothesis 1b: The incidence of chronic pain will be significantly decreased one year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Hypothesis 1c: The severity of chronic pain will be significantly decreased one year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Specific Aim 2: To determine if, compared with current and customary analgesia, the addition of cryoanalgesia improves postoperative functioning. Hypothesis 2a: Following primary unilateral knee and shoulder arthroplasty as well as rotator cuff repair, joint range of motion will be significantly increased within the year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Hypothesis 2b: Following video-assisted thoracoscopic surgery, inspiratory spirometry will be improved within the month following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.

NCT ID: NCT03181139 Completed - Clinical trials for Breast Cancer Female

Efficacy of Enhanced Recovery After Surgery Pathway for Total Mastectomy

ERAS_Breast
Start date: July 1, 2013
Phase: N/A
Study type: Observational

Retrospective analysis of pre and post-Enhanced Recovery after Surgery for Total mastectomy pathway implementation.

NCT ID: NCT03177733 Completed - Mastectomy Clinical Trials

Evaluation of a Breast Double Block Analgesia for the Mastectomy With Radical Axillary Lymphadenectomy Surgery

Start date: June 20, 2017
Phase:
Study type: Observational

This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF block) for the anesthesia of the intercostal nerves anterior branches and assesses the association of the serratus block with a PIF block for the breast surgery. To obtain a correct prospective clinical trial completion we have to begin a new series of inclusion.

NCT ID: NCT03125941 Completed - Breast Cancer Clinical Trials

High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy

DEX-MAS
Start date: March 27, 2017
Phase: Phase 4
Study type: Interventional

The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after breast cancer surgery, with removal of the breast (mastectomy). Primary outcome is the proportion patients who require transfer to the post anaesthesia care unit (PACU) and the proportion that can be transferred directly to the ward. Secondary outcomes are organospecific complications in the postanesthesia phase, pain and nausea the first 5 days, seroma and wound infection the first 14 days and readmissions the first 30 days after surgery. The investigators hypothesize that the frequency of transfer to the PACU and organospecific complications will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections, seroma or readmissions.

NCT ID: NCT03067922 Completed - Quality of Life Clinical Trials

Postmastectomy Pain Syndrome in an Indian Cancer Hospital

Start date: March 6, 2017
Phase:
Study type: Observational [Patient Registry]

Breast cancer is the most common cancer in women in India and accounts for 27% of all cancers in women. Incidence rises in early thirties, peaks at 50-64 years. Approximately 48% are below 50 years of age. Most present when symptoms develop, so are 2B and beyond. Treatment depends on the stage of the disease. Surgical removal of the tumour is part of the treatment attempting a cure. Simple mastectomy involves removal of breast tissue without axillary lymph node dissection or removal of chest wall muscles. Radical mastectomy involves removal of the entire breast, skin, pectoralis major and minor muscles and ipsilateral axillary lymph nodes. Modified radical mastectomy involves removal of the breast and ipsilateral axillary lymph nodes. The pectoralis muscle is preserved. Breast conserving surgery involves removal of tumour with or without axillary dissection. The extent of surgery tells us about the nerve damage, local tissue handling. For example operating in upper and outer quadrant of breast and axilla increases nerve handling in that particular region. Local radiation also plays a role. Persistent pain after mastectomy was first reported in the 1970s by Wood and defined by International Association for Study of Pain (IASP) as pain in the anterior aspect of the thorax, axilla, and/or upper half of the arm beginning after mastectomy or quadrantectomy and persisting for more than three months after surgery and known as Postmastectomy pain Syndrome (PMPS). It is a common problem, with a 25- 60% incidence. The pain is described as burning or tenderness with paroxysms of lancinating, shock-like pain, and also described by some as dysesthesia (perception of non noxious stimuli as painful). Risk factors for PMPS include age, raised Body mass index (BMI), severity of postoperative pain, type of surgery, susceptibility to pain with a history of other pains such as headache and dysmenorrhoea. Axillary hematoma and postoperative radiotherapy have also been implicated in the development of PMPS. Tata Memorial Hospital, is a tertiary cancer institute in India. Around 4000 patients with suspected breast cancers register annually at the hospital and approximately 2800 breast cancer surgeries are performed yearly. Very few studies on PMPS in Indian population exist. We therefore plan to identify the incidence of PMPS in our patients and also the severity of pain along with its impact on daily function and quality of life

NCT ID: NCT03043755 Completed - Mastectomy Clinical Trials

PECS and Parasternal Block for Breast Surgery

PARAST
Start date: July 2016
Phase: N/A
Study type: Observational

Propose to evaluate efficacy of association between US guide parasternal block and pectorals nerves block (PECS) as anesthetic option for breast surgery (medial quadrantectomy and simple mastectomy). All patients undergoing medial quadrantectomy and simple mastectomy in 6 months period will be observed. All patients receive: US guide parasternal block at T4 and T6 space with 6ml of ropivacaine 0,75% and PECS type 2 block performed with 24ml of ropivacaine 0,75%. During surgery patients receive light sedation with continuous infusion of propofol Will be observed: Additional local anesthetic infiltration from surgeon. Pain at rest and during movement quantified as Numerical Rating Scores (0-10) during the first 12 hours postoperatively. Eventual side effects such as nausea/vomiting.

NCT ID: NCT03023007 Completed - Mastectomy Clinical Trials

Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on Chronic Pain of a Mastectomy

PECS
Start date: April 3, 2017
Phase: N/A
Study type: Interventional

A non-randomized, mono-centric, prospective interventional study that will assess the efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a patient will have either received a mastectomy or a mastectomy associated with axillary nodes dissection, and/or a reconstruction by prosthesis.

NCT ID: NCT03003169 Completed - Mastectomy Clinical Trials

Mastectomy in Ambulatory Breast Surgery

MASTAMBU
Start date: April 8, 2016
Phase:
Study type: Observational

This is a prospective observational study, involving 550 mastectomies in Lorraine Institute of Oncology, to assess care patients management of ambulatory surgical compared to standard surgery procedure.

NCT ID: NCT02976103 Completed - Mastectomy Clinical Trials

Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket

Start date: March 7, 2017
Phase: N/A
Study type: Interventional

This research study is studying a garment called the Jacki® recovery jacket that can be worn after surgery as a possible way to manage pain from surgical drains. The study intervention involved in this study is: -"Jacki" recovery jacket

NCT ID: NCT02919891 Completed - Chronic Pain Clinical Trials

Relationship of Intra-Epidermal Nerve Fibre Density (IENFD) and Structure to Chronic Post-Mastectomy Pain Syndrome (PMPS)

Start date: March 1, 2017
Phase:
Study type: Observational

This is a retrospective, observational study which will utilise the Edinburgh Cancer Research Centre's Tissue Bank to provide samples for IENFD testing in those who have undergone mastectomy surgery for breast cancer. The investigators shall identify all those patients in the Tissue Bank database who have undergone mastectomy surgery for breast cancer. The investigators shall consult the patient's electronic health record, and general practitioner if required, to ascertain whether the patient has died, been diagnosed with cognitive impairment or a psychotic disorder, or receiving ongoing oncological treatment which would exclude them from the study. The investigators shall also exclude all those patients who received surgery within the last year as we intend to elucidate the presence of pain in the immediate post-operartive period up to 12 months post-operatively. Having identified these patients the investigators shall contact them via post with a pack containing an information document, a consent form and questionnaires. As this is an observational study we shall contact all of the identified patients who meet the inclusion criteria with the aim of recruiting as many as possible. The investigators would anticipate a high response rate as has been the experience with previous questionnaire studies of breast cancer patients. Once a signed consent form has been returned the patient's tissue sample would undergo IENFD testing. Their questionnaire responses will allow participants to be split into two groups based upon whether they experience CPSP or not. Blinding of this grouping will take place so that those undertaking the IENFD testing are unaware of the patient's questionnaire responses. Statistical analysis of the two group's IEFD results and questionnaire responses will then be undertaken with the null hypothesis that the pre-operative IENFD at the site of surgery does not predict or correlate with CPSP.