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NCT04756791
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.
NCT05444361
Breast cancer is the most common type of cancer in women. Removal of the breast, called "mastectomy", is performed either when there is cancer-or an increased risk of cancer-in the breast. This can result in a lot of pain during the months after surgery. Opioids-"narcotics"-are the most common pain control method provided to patients; but they frequently do not relieve enough pain, have undesirable side effects like vomiting and constipation, and are sometimes misused which can lead to addiction. Mastectomy also frequently results in long-term pain which can interfere with physical and emotional functioning; and the more pain patients have immediately after surgery, the greater the risk of developing long-term pain. Numbing the nerves with local anesthetic can decrease the amount of short- and long-term pain experienced by patients, but even the longest types of these nerve blocks last for hours or days, and not the 1-2 months of pain typically following mastectomy. So, there is reason to believe that if the nerve blocks could be extended so that they last longer than the pain from surgery, short- and long-term pain might be avoided completely without the need for opioids. A prolonged nerve block may be provided by freezing the nerve using a technique called "cryoneurolysis". With cryoneurolysis and ultrasound machines, a small needle-like "probe" may be placed through anesthetized skin and guided to the target nerve to allow freezing. The procedure takes about 5 minutes for each nerve, involves little discomfort, has no side effects, and cannot be misused or become addictive. After 2-3 months, the nerve returns to normal functioning. The investigators have completed a small study suggesting that a single cryoneurolysis treatment may provide potent pain relief after mastectomy. The ultimate objectives of the proposed research study are to determine if temporarily freezing the nerves that go to the breast will decrease short-term pain, opioid use, physical and emotional dysfunction, and long-term pain following mastectomy when added to current and customary postoperative analgesics. The current project is a pragmatic, multicenter, randomized, triple-masked (investigators, participants, statisticians), sham/placebo-controlled, parallel-arm, human-subjects, post-market clinical trial to determine if cryoneurolysis is an effective non-opioid treatment for pain following mastectomy.
NCT06914258
A mastectomy is a medical surgery in which the breast is removed whole or in part. Breast cancer is the second most prevalent cancer diagnosed in women. Rotator cuff dysfunction-related shoulder pain is a common symptom associated with mastectomy, reconstruction, and therapy for breast cancer.) Patients who get treatment for breast cancer report reduced strength (prevalence 17-33%), loss of upper limb range of motion (prevalence 2-51%), and reduced ability to carry out daily life tasks.
NCT05932147
1-Subjects: Sixty-eight patients sample size according to G power who have Axillary web syndrome post mastectomy participated in this study. Their ages ranged from 35 to 55 years. The participants selected from learning hospitals (Al kasr Al Ayni hospital and National cancer institute) and randomly distributed into 2 equal groups. 1.1 Design of study: In this study the patients randomly assigned into two equal groups (34 patients for each group) 1.1(a) Group A: (Pilates Exercise) 1.1(b) Group B: (Manual Lymphatic Drainage) 2\. Equipment's and Tools: Equipment in this study divided into two main categories: measuring and therapeutic equipment. 2.1. Measuring Equipment: The following tools are used to assess Range of motion and pain for shoulder joint: 2.1 (a) Measuring and assessment of pain by: * Visual analogue scale 2.2 (b) Measuring range of motion (ROM) by: * Electronic Goniometer 2.3 (c) Measuring Disability of the arm, shoulder and hand by: * DASH questionnaire (Disability of the arm, shoulder and hand). 2.2. Therapeutic Equipment: 1. Pilates exercise 2- Manual lymphatic drainage 3. Procedures of the study: The procedures of this study are classified into the following: 3.1 Measurement Procedures: All measurements have been taken before treatment (pre) after 9 weeks (post 1) after 9 weeks (post 2). 1.1 (a) Assessment of pain of shoulder joint • Assessment of upper limb pain using visual analogue scale 3.1(b) Assessment of Range of motion of shoulder joint: By Electronic Goniometer. 3.1 (c) Assessment of Disability of the arm, shoulder and hand The disabilities of the arm, shoulder and hand questionnaire (DASH) 1.2 Therapeutic procedures: 3.2(a) procedures of Pilates exercise program: 1. Shoulder Abduction with External Rotation exercise 2. Shoulder bridge exercise 3. Mermaid sitting exercise. 4. Standing Pilates mermaid exercise with towel 5. Rocking exercise 6. Saw Pilates exercise. 7. Bird-dog Pilates exercise. 8. Roll up exercise. 9. Cobra pose exercise. 10. Child pose exercise.
NCT05914415
Breast cancer is one of the most common types of cancer today. Treatment is planned depending on various factors. The most common treatment option is surgery. Mastectomy is a type of surgery in which the entire breast is removed. Tumorous tissue is removed with mastectomy, and cancer is treated, but after the intervention, physiological, psychological and social problems may occur in individuals in the acute and chronic periods. By providing pre-operative education, complications in the postoperative period can be reduced and the patient's compliance with the treatment can be ensured. It is stated in the studies that the training given by the nurses with different methods before the surgery reduces the anxiety, pain level and increases the comfort of the patients. No study was found in which the preoperative structured education given to patients scheduled for mastectomy was evaluated with the Postoperative Healing Quality Scale. The study is planned to be conducted as a randomized controlled experimental study and the patients who applied to Bakırköy Dr.Sadi Konuk Training and Research Hospital General Surgery Clinic for mastectomy constitute the research population. The sample is planned to consist of 70 patients, including 35 control and 35 experimental groups. In the structured training program in the research, both face-to-face information will be given to the patients and a written training booklet will be used. Patient Diagnosis Form, Recovery Quality Scale will be used to collect data. Through the data obtained, it will be evaluated whether the education given to the patients who are planned for mastectomy has an effect on the quality of recovery in the early postoperative period. It is thought that this study will reveal the benefits of preoperative education, increase the health care satisfaction of the patients and support their recovery.
NCT05286489
PURPOSE: to assess the efficacy of Qigong exercise on microcirculation in postmastectomy lymphedema patient. BACKGROUND: Qigong is a mind-body integrative exercise originating from traditional Chinese medicine and is used to improve health and energy levels through regular training, yet its effects are not empirically assessed. Qigong may be a potentially beneficial exercise for survivors of breast cancer and could be used to regulate upper limb blood flow and decrease lymphedema. There is lack in knowledge and information in published studies about the efficacy of Qigong exercise on microcirculation in postmastectomy lymphedema patient. So, this study will be designed to provide a guideline about the efficacy of Qigong exercise on microcirculation in postmastectomy lymphedema patient. HYPOTHESES: It will be hypothesized that: It was hypothesized that Qigong exercise has no or limited effect in microcirculation in postmastectomy lymphedema patient. RESEARCH QUESTION: Does Qigong exercise an effect on microcirculation in postmastectomy lymphedema patient?
NCT04246034
this study aims to evaluate the outcomes of simultaneous free abdominal flap \& vascularized lymph node transfer for both breast reconstruction and postmastectomy lymphedema
NCT04356235
This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of life and patient satisfaction after breast reconstructive surgery with silicone implant (following SSM, ASM or NSM mastectomy) and symmetrization (mastopexy and/or silicone implant and/or Ultrapro mesh sling technique) over time. According to the hypothesis of the study, the results of implant-based breast reconstruction and symmetrization following advanced postmastectomy techniques significantly decrease over time and later results limited patient satisfaction rate. This is mainly due to the fact that over time, the natural breast differs from the reconstructed breast with silicone implant. Because of the different biological properties (gravity results ptosis on breast with mastopexy, significant volume increasement of the breast with mastopexy due to endocrine therapy, gradually progressive capsular contracture on the tumorous side, nipple flattening, nipple tattoo fading etc.) the two sides change differently resulting in significant asymmetry and consequently could lead to decreased patient satisfaction. The high degree of asymmetry over time (which can be similar to the difference between the result of a simple mastectomy and natural breast (control group)), may indicates additional surgeries or usage of medical devices, putting a financial burden on the patient and the health system. On the other hand, the symmetry can be achieved with bilateral skin-sparing mastectomies and implant-based immediate or delayed-immediate reconstructions is clearly better and change less with time. The mastectomy of the contralateral disease-free side is considered as an unreasonable burden for moderate risk patients. The information such as the need for multiple surgeries, change in symmetry over time etc., should be an important part of the professional decision-making mechanism and the surgeon should inform the patient during the primer surgery. Nowadays due to the lack of evidence-based knowledge, it is not part of the patient's information and surgical planning internationally. Planning breast units, attention, capacity and financial resources must also be provided to meet the long-term needs of patients who underwent postmastectomy breast reconstruction. Simple mastectomy with an external prosthesis can be an alternative for patients with intolerable degree of asymmetry or on the contrary, the results may justify the need for bilateral mastectomy and reconstruction even in the absence of high oncological risk and for purely symmetrical and cosmetic reasons.
NCT04345081
This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of life and patient satisfaction after delayed- immediate breast reconstruction with standardized technique Skin Reducing Nipple sparing mastectomy, SRNSM and SSM with standardized horizontal skin incision. According to our hypothesis, SRNSM with standardized technique on pendulous/ ptotic breasts is a safe procedure compared to SSM. It also promotes the cosmetic efficacy of SRNSM with the removal of the entire glandular tissue through avoidance of the reduction of projection, the need later nipple reconstruction surgery and of areola tattoo. In our study we propose that compared to one of the well-known and widely investigated studied SSM, our current standardized SRNSM technique is able to perform similar oncologically safe entire gland tissue removal, with low complication rate, accommodating for adjuvant treatments. Furthermore, it may provide superior cosmetic results than SSM (NAC is not removed, projection is maintained, and there is no need for further nipple reconstruction or tattoo) with high patient satisfaction which is maintained long term.
NCT04184102
A Randomized Control Trial (RCT) on the effect of education and Exercise on women after a mastectomy found positive results in range of motion of the affected shoulder and quality of life in the intervention group.
NCT04166279
This study emphasizes the importance of rehabilitation in breast cancer survivors after mastectomy, even during the course of radiotherapy and chemotherapy, both for good efficacy in reducing pain and for functional recovery of the upper limb. Authors designed a randomized-controlled trial to compare two different rehabilitation protocols: the single rehabilitative treatment (ST) and the group treatment (GT). The study is the first attempt to measure the reaching movement after BC surgery with an optoelectronic evaluation system previously standardized in the neurological field during rehabilitation treatment.
NCT04145739
The hypothesis behind our study was that patients after BC surgery, who underwent quadrantectomy or mastectomy, may present a different disability respect to the upper limb on the operated side. Accordingly they could have a different functional recovery patterns after rehabilitation. The aim of our study was to compare the recovery of the fluidity of the reaching movement (Jerk) as the primary outcome, the reduction of shoulder pain and improvement of disability for the upper limb respect the operated side as secondary outcomes, before and after a specific rehabilitation protocol treatment.