Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia
Condition: Postoperative Analgesia; Hand Strength; Health Related Quality of Life; Chronic Shoulder Pain; Breast Cancer Female; Surgical Wound Infiltration; Lymph Node Dissection
MeSH terms: Breast Neoplasms; Shoulder Pain; Wounds and Injuries; Surgical Wound
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Diclofenac Sodium; Levobupivacaine bolus analgesia; Levobupivacaine PCA group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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; 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.; 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.
Other intervention name(s): Nonsteroidal antiinflammatory drug; Postoperative wound infiltration with bolus applications of local anesthetic, Chirocaine 0.5%; Postoperative continuous wound infiltration analgesia with local anesthetic, Chirocaine 0.5%
Intervention MeSH terms: Diclofenac; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Anesthetics; Levobupivacaine; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Postoperative Pain; Breast Cancer; Postoperative analgesia; Patient-Controlled Analgesia; Levobupivacaine; Diclofenac; Hand Grip Strength; Quality of life; Treatment Outcome