Clinical trial NCT05829707: Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia
Official title: Long-term Outcomes of Breast Cancer Patients Receiving Levobupivacaine Wound Infiltration or Diclofenac for Postoperative Pain Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Analgesia
Hand Strength
Health Related Quality of Life
Chronic Shoulder Pain
Breast Cancer Female
Surgical Wound Infiltration
Lymph Node Dissection
Keywords: Acute Postoperative Pain
Breast Cancer
Postoperative analgesia
Patient-Controlled Analgesia
Levobupivacaine
Diclofenac
Hand Grip Strength
Quality of life
Treatment Outcome
Lead sponsor: Osijek University Hospital
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative analgesia
timeFrame: from 1-4 days postoperative, day of surgery is day 1
measure: Hand grip strength
timeFrame: Before surgery, on day 4 after surgery, and one year after surgery
measure: Shoulder disability
timeFrame: Before surgery and after one year at surgical control.
measure: Health related quality of life
timeFrame: Before surgery and after one year at surgical control.
Secondary outcomes:
measure: Long-term survival - 5 years after surgery
timeFrame: Five years after surgery
measure: Long term survival - 10 years after surgery
timeFrame: Ten years after surgery until data were collected
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anaesthesiology, Resuscitation and ICU, Osijek University Hospital,
name: Josipa Glavas Tahtler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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