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

NCT ID: NCT05829707

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-05
• Study Completion Date: 2023-04-05

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Diclofenac

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 Type: ACTIVE_COMPARATOR

Diclofenac Sodium

Intervention Type: DRUG

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

Levobupivacaine bolus analgesia

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 Type: EXPERIMENTAL

Levobupivacaine bolus analgesia

Intervention Type: DRUG

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 PCA group

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.

Group Type: EXPERIMENTAL

Levobupivacaine PCA group

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

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%

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Osijek University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josipa Glavas Tahtler, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, Resuscitation and ICU, Osijek University Hospital,

References

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Other Identifiers

OsijekUH21

Identifier Type: -

Identifier Source: org_study_id