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

Osijek University Hospital

Status and phase: Completed; Phase 4

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

Treatments: Drug: Diclofenac Sodium; Drug: Levobupivacaine PCA group; Drug: Levobupivacaine bolus analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05829707

OsijekUH21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer patients whose disease requires axillary lymph node dissection
• who consented to participate in the study
• aged 30 - 75
• The patient is able to understand all three methods of analgesia
• Patients can receive any of the study drugs
• Able to understand and complete questionnaires on quality of life and shoulder pain

Exclusion criteria

• Age <30 years - >75 years
• Patients who refused to participate in the study (at any stage of the study)
• Patients who after histological analysis did not require axillary lymph node dissection
• Patients with known intolerance to study drugs
• Patients who unintentionally removed wound infiltration catheters.
• Patients who required surgical reintervention during the study period
• Patients having adverse reactions to any study drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Diclofenac

Active Comparator group

Description:

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.

Treatment:

Drug: Diclofenac Sodium

Levobupivacaine bolus analgesia

Experimental group

Description:

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.

Treatment:

Drug: Levobupivacaine bolus analgesia

Levobupivacaine PCA group

Experimental group

Description:

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.

Treatment:

Drug: Levobupivacaine PCA group