Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Musculoskeletal Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Rare Diseases

Breast Neoplasms

Pain, Postoperative

Influenza, Human

Pain

Shoulder Pain

Surgical Wound

Breast Diseases

Skin Diseases

Neurologic Manifestations

Arthralgia

Joint Diseases

Quality of Life

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Adjuvants, Anesthesia

Anesthetics

Anesthetics, Local

Levobupivacaine

Diclofenac

Anti-Inflammatory Agents, Non-Steroidal

Meperidine

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

All patients underwent quadrantectomy or mastectomy with axillary lymph node dissection. They received diclofenac 2 x 75 mg intravenously on the first day after surgery. During the 3 subsequent days, from day 2 to day 4 postoperatively patients were given 3 x 50 mg diclofenac tablets orally. The medicine was delivered by the nurse, and the patients drank tablets in front of her.

Group Levobupivacaine Bolus received 0.5 mg/kg 0.5% Levobupivacaine HCl every 8 h via wound catheter. The dose of levobupivacaine was prescribed by the doctor and the drug was delivered by the nurse.

Group Levobupivacaine patient-controlled analgesia (PCA) received 0.05 mg/kg 0.5% Levobupivacaine HCl continuously via wound catheter delivered by CADD - Legacy® PCA Pump. These patients were allowed to add a dose of 7.5 mg 0.5% levobupivacaine in case of pain by pressing the patient's button on the PCA pump, with a lock-out period of 4 hours.

A group of patients with breast cancer who were randomized to the diclofenac group by drawing random numbers was given 2 x 75 mg of drug IV on the first PO day and then 3 x 50 mg tablets orally for postoperative analgesia.

All patients were assessed before the surgical procedure: hand grip strength, shoulder disability, and health-related quality of life were measured. Pain relief was assessed by the visual analog scale (VAS) from 0-10.

Rescue analgesia was offered for pain \>4 on the VAS, meperidine 20-30 mg for VAS \>or = 4

Diclofenac Sodium

The levobupivacaine dose was calculated by a doctor. A wound infiltration catheter was inserted at the end of the surgical procedure by a surgeon. A first dose of local anesthetic was delivered at the end of the surgical procedure to test catheter placement. Bolus doses of local anesthetics based on the patients' body weight were thereafter delivered by the nurse in 8 hours intervals.

All patients were assessed before the surgical procedure and hand grip strength, shoulder disability, and health-related quality of life were measured. Pain relief was assessed by the visual analog scale (VAS) from 0-10.

Rescue analgesia was offered for pain \>4 on the VAS, meperidine 20-30 mg for VAS \>or = 4.

Levobupivacaine bolus analgesia

The levobupivacaine dose was calculated by a doctor. A wound infiltration catheter was inserted at the end of the surgical procedure by a surgeon. Levobupivacaine was delivered by PCA pump (CADD - Legacy® PCA Pump, Model 6300, Smiths Medical MD, Inc., St. Paul, USA). A drug delivery was started at the end of the surgical procedure.

All patients were assessed before the surgical procedure: hand grip strength, shoulder disability, and health-related quality of life were measured. Pain relief was assessed by the visual analog scale (VAS) from 0-10.

Rescue analgesia was offered for persisting pain \>4 on the VAS, and meperidine 20-30 mg for VAS \>or = 4.

Levobupivacaine PCA group

Josipa Glavas Tahtler, MD

In the study that was conducted from 05.01.2009 - 31.12.2012. 120 patients were examined. By drawing random numbers, the patients were randomized into 3 groups for postoperative analgesia:

1. Diclofenac 2 mg/kg/day - control,
2. Wound infiltration via wound catheter with catheter tip placed in the axilla, 3\*0.5 mg/kg 0.5% levobupivacaine bolus dose.
3. 0.05 mg/kg/h 0.5% levobupivacaine continuously via wound infiltration catheter with catheter tip placed in the axilla. The drug was delivered using a PCA pump for 24 hours.

The aim was to compare early postoperative outcomes - pain control on a visual analog scale of 1-10, hand grip strength, and quality of life after surgery and after 1 year.

Long-term survival was examined subsequently, from the hospital register.

Before the operation, the patients were randomized into 3 groups: the first group received diclofenac for postoperative analgesia. On the first day, they received 2 x 75 mg intravenously, and then 3 x 50 mg tablets. For the wound infiltration with levobupivacaine, a perforated catheter was placed at the end of the surgical procedure by the surgeon in both groups of patients. The tip of the catheter was in the axillary fossa, where the dissection was performed. Patients in the levobupivacaine bolus group (N=39) received three times a day bolus doses of 0.5 mg/kg 0.5% levobupivacaine (Chirocaine, Abbot S.p.A., Latina, Italy) through the catheter. The dose of levobupivacaine was prescribed by the doctor, and the drug was delivered by the nurse. In levobupivacaine, PCA group (N=40) women had the same catheter placed, but received 0.05 mg/kg/h 0.5% levobupivacaine continuously for 24 hours via a catheter placed in the axilla. Levobupivacaine was delivered by PCA pump (CADD - Legacy® PCA Pump, Model 6300, Smiths Medical MD, Inc., St. Paul, USA). These patients were allowed to add a dose of 7.5 mg 0.5% levobupivacaine in case of pain by pressing the patient's button on the PCA pump, with a lock-out period of 4 hours. Postoperative pain was measured with a visual analog scale (VAS). All patients had the option of additional analgesia, using NSAIDs for pain \<4 or meperidine for VAS \>4. After the surgery, the patients received oncological chemoradiotherapy, depending on the type and stage of cancer.

On the one-year control examination, the investigator was blinded on the type of postoperative analgesia

Female breast cancer patients were included in the study

Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia

Long-term Outcomes of Breast Cancer Patients Receiving Levobupivacaine Wound Infiltration or Diclofenac for Postoperative Pain Relief

data may be shared upon request from researchers.

Pain after mastectomy was evaluated by self-reports from patients using a Visual Analog Scale (VAS) from 0 - no pain up to 10 - the worst pain imaginable.

Hand grip strength (HGS) was measured preoperatively, 4 days after surgery and at follow-up after 1 year, using a handheld dynamometer (Dynatest®, Rud. Reister Gmbh\&CaKG, Jungingen, Germany) and expressed in bars. Mean expected normal values for female patients are in the range between 0.4-0.6 bar.

Shoulder pain was assessed using the Shoulder Disability Questionnaire (SDQ), and shoulder pain was assessed in 16 typical situations such as writing, opening a door, sleeping on the operated side, or carrying a load. The maximal score was all positive ( 16 in 16, 100%), suggesting that pain was present in all 16 clinical situations, and the minimum score is 0 (0 positive responses /16 situations, 0% - no disability in any situation.

Health-related quality of life was assessed using the Croatian version of the SF-36 questionnaire. There were eight domains examined: physical health, role limitation due to physical problems, pain, general health perception, energy / vitality, social functioning, limitations due to emotional problems, and general mental health.

This instrument summarizes health perception from the patient's perspective. SF-36 scores range from 0 (worst) to 100 (best) (5).

Survival after 5 years from the surgery will be checked through the hospital registry, or for those who died through the official population records and death registers of the Republic of Croatia. Patients' outcomes are dichotomous and are presented as alive or dead 5 years after surgery.

Survival after 10 years from the surgery will be checked through the hospital registry, or for those who died through the official population records and death registers of the Republic of Croatia. Patients' outcomes are dichotomous and are presented as alive or dead 10 years after surgery.

Spots Global Cancer Trial Database for levobupivacaine bolus analgesia