Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Wounds and Injuries

Breast Neoplasms

Analgesics

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Bupivacaine

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Epinephrine

Anesthetics, Local

Analgesics, Opioid

Diclofenac

Racepinephrine

Epinephryl borate

Patients will receive intraoperative wound soakage with 20ml of 0.5% bupivacaine with adrenaline by the surgeon before closure and receive a continuous infusion of 4ml/hr of 0.2% bupivacaine delivered by an elastomeric pump the catheter of which will be placed by the surgeon in the wound before closure. Postoperative anlagesia will be provided with oxycodone, paracetamol and diclofenac.

Patients will receive morphine up to 0.1mg/kg intraoperatively. Postoperative analgesia will be provided with oxycodone, paracetamol and diclofenac.

intraoperative wound soakage with 20ml of 0.5% bupivacaine with epinephrine and continuous infusion of 4ml/hr of 0.2% bupivacaine for 48 hours postoperatively

Denise M McCarthy, MB FCARCSI

Brian O'Donnell, MD FCARCSI

Axillary clearance forms part of the surgical armamentarium for the treatment of breast cancer. Although the introduction of sentinel lymph node mapping and dissection has allowed for the decreased use of axillary clearance, it remains a frequently performed operation. Axillary clearance is associated with moderate postoperative pain.

We hypothesize that a continuous wound infusion of 0.2% Bupivacaine at 4ml/hr would provide superior analgesia, when compared to standard opioid-based analgesia, in patients undergoing axillary lymph node clearance surgery.

The study will take the form of a prospective randomised clinical trial. The following assessment tools will be used

* The visual analogue scale (VAS) consists of a 100 mm horizontal line with the two end points labelled "no pain" and "worst pain ever". Patients are asked to mark on the line a point that corresponds to the level of pain intensity they feel. The score is obtained by measuring the distance (mm) from the left end of the line.
* The short-form McGill Pain Questionnaire (SF-MPQ) consists of 15 representative words from the sensory and affective categories of the standard McGill Pain Questionnaire. It also includes the present pain intensity and a VAS to provide overall indices of pain intensity. It has been shown to be sensitive to clinical changes brought about by various interventions, postoperative analgesic drugs (6).
* The Pain Catastrophising Score (PCS) is a 13 item instrument which asks patient to reflect on past painful experiences, and to indicate the degree to which they experienced each of these 13 thoughts or feelings, on 5-point scales with the end points; 0 = not at all, 4 = all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness (7).
* The Hospital Anxiety and Depression Score (HADS) is a 14-item scale, which screens for these, the two most common disturbances encountered in a medical setting (8).

Use of Continuous Wound Infusion of Bupivacaine for Analgesia Following Axillary Clearance Surgery

Does Continuous Wound Infusion of 0.2% Bupivacaine Provide Superior Analgesia Compared to Standard Opioid-based Therapy in Patients Following Axillary Clearance Surgery?

Cork University Hospital

Denise McCarthy

Blood and Lymph Conditions

Symptoms and General Pathology

Lymphocele

Breast Diseases

Skin Diseases

Cysts

Lymphatic Diseases

Antineoplastic Agents

Gastrointestinal Agents

Octreotide

Antineoplastic Agents, Hormonal

Intramuscular injection of sandostatin 30 mg 3 days before surgery

Injection of sandostatine

EMMANUELLE MARTIN, MD

The lymphocele is the main early postoperative complication of axillary clearance for breast cancer patients with rates up to 85%.

The usual treatment consists of external drainage. However, this method increases the duration of hospitalization.

As a result, some practitioners have abandoned drainage, allowing for ambulatory surgery.

If this solution makes it possible to reduce the duration of the hospitalizations, it involves iterative punctures of the axillary hollow in case of lymphocele These punctures may be responsible for pain, hematoma or infection of the operative site.

To date, no method has proved superior in terms of decreasing the incidence of lymphocele postoperatively axillary clearance.

Octreotide (Sandostatin®) is a peptide, one of whose effects is to reduce the inflammation responsible for lymphoceles.

The aim of the study is to inject Sandostatin® before surgery, with the aim of reducing the incidence of seroma by 50% after axillary clearance

A phase II prospective, single-center, non-randomized study.

Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation

Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation In Patients With Breast Cancer

The frequency of occurrence of a lymphocele requiring at least one evacuation puncture.

Determined by the volume of the punctures carried out

Determined by the data recovered from the Health Insurance

Institut Cancerologie de l'Ouest

Patients randomised to early drainage removal arm will have the drain removed in postoperative day 1. Lymph will be punctured on a regular basis

Patients randomised to late drainage removal arm will have the drains kept until total daily drainage is 30ml and then removed

Drainage will be removed in postoperative day 1

Early drainage removal

Drains will be kept until daily drainage is 30ml and then removed

Late drainage removal

Jacek Zielinski, MD, PhD

Pawel Kabata, MD

Jacek Zielinsk, MD, PhD

Maciej Bobowicz, MD

Piotr Rak, MD, PhD

Iwona Chruscicka, MD, PhD

Radoslaw Jaworski, MD, PhD

Janusz Jaśkiewicz, MD, PhD

The aim of the study is to assess whether early drainage removal in patients with less than 150ml of lymph in postoperative day 1 can reduce total lymphorrhoea

Patients with early drainage removal will be compared with patients in whom drainage will be kept until daily lymphorrhoea is 30ml

Effect of Early vs Late Drainage Removal in Women After Radical Mastectomy With Axillary Clearance

Prospective Randomised Clinical Trial Comparing the Effect of Early and Late Drainage Removal in Female Patients After Radical Mastectomy With Axillary Clearance

Assessment of total lymph volume and lymphorrhoea time up to 3 months after the surgery

Post operative pain assessment using VAS (Visual Analogue Scale) scale until 30 days after surgery

Medical University of Gdansk

Assistant Profesor

Bone Density Conservation Agents

Anticoagulants

Other Dietary Supplements

Tamoxifen

Citric Acid

Sodium Citrate

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Citrate

Either a total mastectomy with axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) with axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse.

Either a total mastectomy without axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) without axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse.

20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.

tamoxifen citrate

Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).

conventional surgery

No radiotherapy is to be given after mastectomy. Radiotherapy is optional after breast conserving surgery according to prospectively determined guidelines within each institution. It should be given to the breast only and not to the draining node areas.

radiation therapy

Axillary clearance

Diana Crivellari, MD

RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast cancer cells. It is not yet known if surgery to remove breast cancer is more effective with or without lymph node removal.

PURPOSE: Randomized phase III trial to compare the effectiveness of breast surgery with or without removal of axillary lymph nodes in treating women who have stage I or stage IIA breast cancer.

OBJECTIVES:

* Compare local and systemic disease-free survival, ipsilateral axillary relapse, occurrence of postmastectomy syndrome, and overall survival of elderly women with clinically operable stage I or IIA breast cancer who subsequently receive adjuvant tamoxifen after treatment with breast surgery with or without axillary node dissection.
* Compare the toxicity of these regimens in these patients.
* Compare the quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether they received prior primary surgery (yes vs no) and participating center.

* Arm I: Patients undergo mastectomy, lumpectomy, or quadrantectomy with axillary clearance. Patients then receive oral tamoxifen for 5 years. Patients may also undergo sentinel node biopsy.
* Arm II: Patients undergo surgery as in arm I without axillary clearance. Patients then receive oral tamoxifen for 5 years.

Patients in both arms who undergo breast-conserving surgery may receive optional radiotherapy for 5-6 weeks to the remaining breast tissue, chest, and lung. Upon recurrence in the conserved breast, patients undergo total mastectomy; those in arm II who experience ipsilateral axillary recurrence undergo surgical excision. Adjuvant tamoxifen and follow up are continued.

Quality of life is assessed.

Patients are followed every 3 months for 1 year, every 6 months while receiving tamoxifen, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,020 patients will be accrued for this study within approximately 5 years.

Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer

Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.

Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.

Side effects of treatment, especially surgery-related events.

Quality of life will be assessed by standard International Breast Cancer Study Group instruments

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Use of Continuous Wound Infusion of Bupivacaine for Analgesia Following Axillary Clearance Surgery	NCT01314144	Breast Cancer	Bupivacaine	18 Years -	Cork University Hospital
Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation	NCT03791736	Breast Cancer Lymphocele	Injection of sa...	18 Years -	Institut Cancerologie de l'Ouest
Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation	NCT03791736	Breast Cancer Lymphocele	Injection of sa...	18 Years -	Institut Cancerologie de l'Ouest
Effect of Early vs Late Drainage Removal in Women After Radical Mastectomy With Axillary Clearance	NCT01221064	Breast Cancer	Early drainage ... Late drainage r...	18 Years - 75 Years	Medical University of Gdansk
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer	NCT00002528	Breast Cancer	tamoxifen citra... conventional su... radiation thera... Axillary cleara...	60 Years -	ETOP IBCSG Partners Foundation
Use of Continuous Wound Infusion of Bupivacaine for Analgesia Following Axillary Clearance Surgery	NCT01314144	Breast Cancer	Bupivacaine	18 Years -	Cork University Hospital

Spots Global Cancer Trial Database for axillary clearance