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Completed

NCT Number: NCT05829707

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diclofenac Sodium

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

Other names: Nonsteroidal antiinflammatory drug

Levobupivacaine bolus analgesia

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.

Other names: Postoperative wound infiltration with bolus applications of local anesthetic, Chirocaine 0.5%

Levobupivacaine PCA group

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.

Other names: Postoperative continuous wound infiltration analgesia with local anesthetic, Chirocaine 0.5%

Primary outcomes

  1. Postoperative analgesia

    Time frame: from 1-4 days postoperative, day of surgery is day 1

    Pain after mastectomy was evaluated by self-reports from patients using a Visual Analog Scale (VAS) from 0 - no pain up to 10 - the worst pain imaginable.

  2. Hand grip strength

    Time frame: Before surgery, on day 4 after surgery, and one year after surgery

    Hand grip strength (HGS) was measured preoperatively, 4 days after surgery and at follow-up after 1 year, using a handheld dynamometer (Dynatest®, Rud. Reister Gmbh&CaKG, Jungingen, Germany) and expressed in bars. Mean expected normal values for female patients are in the range between 0.4-0.6 bar.

  3. Shoulder disability

    Time frame: Before surgery and after one year at surgical control.

    Shoulder pain was assessed using the Shoulder Disability Questionnaire (SDQ), and shoulder pain was assessed in 16 typical situations such as writing, opening a door, sleeping on the operated side, or carrying a load. The maximal score was all positive ( 16 in 16, 100%), suggesting that pain was present in all 16 clinical situations, and the minimum score is 0 (0 positive responses /16 situations, 0% - no disability in any situation.

  4. Health related quality of life

    Time frame: Before surgery and after one year at surgical control.

    Health-related quality of life was assessed using the Croatian version of the SF-36 questionnaire. There were eight domains examined: physical health, role limitation due to physical problems, pain, general health perception, energy / vitality, social functioning, limitations due to emotional problems, and general mental health.

    This instrument summarizes health perception from the patient's perspective. SF-36 scores range from 0 (worst) to 100 (best) (5).

Secondary outcomes

  1. Long-term survival - 5 years after surgery

    Time frame: Five years after surgery

    Survival after 5 years from the surgery will be checked through the hospital registry, or for those who died through the official population records and death registers of the Republic of Croatia. Patients' outcomes are dichotomous and are presented as alive or dead 5 years after surgery.

  2. Long term survival - 10 years after surgery

    Time frame: Ten years after surgery until data were collected

    Survival after 10 years from the surgery will be checked through the hospital registry, or for those who died through the official population records and death registers of the Republic of Croatia. Patients' outcomes are dichotomous and are presented as alive or dead 10 years after surgery.

Sponsors and collaborators

Lead sponsor

Osijek University Hospital

Other

Registry information

Official study title

Long-term Outcomes of Breast Cancer Patients Receiving Levobupivacaine Wound Infiltration or Diclofenac for Postoperative Pain Relief

Important dates

Study start
2009
Primary completion
2012
Study completion
2023
First posted
Apr 26, 2023
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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