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

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.

Conditions

• Postoperative Analgesia
• Hand Strength
• Health Related Quality of Life
• Chronic Shoulder Pain
• Breast Cancer Female
• Surgical Wound Infiltration
• Lymph Node Dissection

Interventions

DRUG

Diclofenac Sodium

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

DRUG

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. 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.

DRUG

Levobupivacaine PCA group

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.

Sponsors & Collaborators

• Osijek University Hospital

  lead OTHER

Principal Investigators

• Josipa Glavas Tahtler, MD · Department of Anaesthesiology, Resuscitation and ICU, Osijek University Hospital,

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-05

Primary Completion

2012-12-31

Completion

2023-04-05

FDA Drug

Yes