Postoperative AnalgesiaPhase 4NCT05829707
Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia
A Phase 4 study testing Diclofenac Sodium, Levobupivacaine bolus analgesia and Levobupivacaine PCA group in people with Postoperative Analgesia and Hand Strength, run by Osijek University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Postoperative Analgesia, Hand Strength, Health Related Quality of Life
- What is being tested?
- Diclofenac Sodium, Levobupivacaine bolus analgesia and Levobupivacaine PCA group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2009to 5 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Long-term Outcomes of Breast Cancer Patients Receiving Levobupivacaine Wound Infiltration or Diclofenac for Postoperative Pain Relief
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:
- Diclofenac 2 mg/kg/day - control,
- Wound infiltration via wound catheter with catheter tip placed in the axilla, 3*0.5 mg/kg 0.5% levobupivacaine bolus dose.
- 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.
Read more
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.
Read the 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
- Being tested
- Diclofenac Sodium, Levobupivacaine bolus analgesia, Levobupivacaine PCA group
- Keywords
- Acute Postoperative Pain, Breast Cancer, Postoperative analgesia, Patient-Controlled Analgesia, Levobupivacaine, Diclofenac, Hand Grip Strength, Quality of life, Treatment Outcome
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac SodiumDrug
Also called Nonsteroidal antiinflammatory 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 analgesiaDrug
Also called Postoperative wound infiltration with bolus applications of local anesthetic, Chirocaine 0.5%
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 groupDrug
Also called Postoperative continuous wound infiltration analgesia with local anesthetic, Chirocaine 0.5%
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.
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac | Active comparator | 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. Receives: Drug: Diclofenac Sodium |
| Levobupivacaine bolus analgesia | Experimental | 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. Receives: Drug: Levobupivacaine bolus analgesia |
| Levobupivacaine PCA group | Experimental | 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. Receives: Drug: Levobupivacaine PCA group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
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.
Measured: from 1-4 days postoperative, day of surgery is day 1
Hand grip strength
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.
Measured: Before surgery, on day 4 after surgery, and one year after surgery
Shoulder disability
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.
Measured: Before surgery and after one year at surgical control.
Health related quality of life
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).
Measured: Before surgery and after one year at surgical control.
Secondary outcomes (2)
Long-term survival - 5 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.
Measured: Five years after surgery
Long term survival - 10 years after surgery
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.
Measured: Ten years after surgery until data were collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start5 Jan 2009
- Primary completion31 Dec 2012
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josipa Glavas Tahtler, MD, Principal investigator, Department of Anaesthesiology, Resuscitation and ICU, Osijek University Hospital,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829707
- Sponsor's protocol ID
- OsijekUH21
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: data may be shared upon request from researchers.
Publications
Beguinot M, Monrigal E, Kwiatkowski F, Ginzac A, Joly D, Gayraud G, Le Bouedec G, Gimbergues P. Continuous Wound Infiltration With Ropivacaine After Mastectomy: A Randomized Controlled Trial. J Surg Res. 2020 Oct;254:318-326. doi: 10.1016/j.jss.2020.05.006. Epub 2020 Jun 5.
PubMed 32512380Kaur U, Shamshery C, Agarwal A, Prakash N, Valiveru RC, Mishra P. Evaluation of postoperative pain in patients undergoing modified radical mastectomy with pectoralis or serratus-intercostal fascial plane blocks. Korean J Anesthesiol. 2020 Oct;73(5):425-433. doi: 10.4097/kja.20159. Epub 2020 Sep 24.
PubMed 32987492Li R, Xiao C, Liu H, Huang Y, Dilger JP, Lin J. Effects of local anesthetics on breast cancer cell viability and migration. BMC Cancer. 2018 Jun 19;18(1):666. doi: 10.1186/s12885-018-4576-2.
PubMed 29914426Chen JL, Liu ST, Huang SM, Wu ZF. Apoptosis, Proliferation, and Autophagy Are Involved in Local Anesthetic-Induced Cytotoxicity of Human Breast Cancer Cells. Int J Mol Sci. 2022 Dec 7;23(24):15455. doi: 10.3390/ijms232415455.
PubMed 36555096Castelli V, Piroli A, Marinangeli F, d'Angelo M, Benedetti E, Ippoliti R, Zis P, Varrassi G, Giordano A, Paladini A, Cimini A. Local anesthetics counteract cell proliferation and migration of human triple-negative breast cancer and melanoma cells. J Cell Physiol. 2020 Apr;235(4):3474-3484. doi: 10.1002/jcp.29236. Epub 2019 Sep 20.
PubMed 31541469Kwakye AK, Kampo S, Lv J, Ramzan MN, Richard SA, Falagan AA, Agudogo J, Atito-Narh E, Yan Q, Wen QP. Levobupivacaine inhibits proliferation and promotes apoptosis of breast cancer cells by suppressing the PI3K/Akt/mTOR signalling pathway. BMC Res Notes. 2020 Aug 17;13(1):386. doi: 10.1186/s13104-020-05191-2.
PubMed 32807213Klein I, Kalichman L, Chen N, Susmallian S. Effect of physical activity levels on oncological breast surgery recovery: a prospective cohort study. Sci Rep. 2021 May 17;11(1):10432. doi: 10.1038/s41598-021-89908-8.
PubMed 34002007Meerkerk CDA, Chargi N, de Jong PA, van den Bos F, de Bree R. Sarcopenia measured with handgrip strength and skeletal muscle mass to assess frailty in older patients with head and neck cancer. J Geriatr Oncol. 2021 Apr;12(3):434-440. doi: 10.1016/j.jgo.2020.10.002. Epub 2020 Oct 13.
PubMed 33067163Glavas Tahtler J, Djapic D, Neferanovic M, Miletic J, Milosevic M, Kralik K, Neskovic N, Tomas I, Mesaric D, Marjanovic K, Rajc J, Orkic Z, Cicvaric A, Kvolik S. Long-Term Outcomes of Breast Cancer Patients Receiving Levobupivacaine Wound Infiltration or Diclofenac for Postoperative Pain Relief. Pharmaceutics. 2023 Aug 23;15(9):2183. doi: 10.3390/pharmaceutics15092183.
PubMed 37765154
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Breast Cancer Patients Receiving Levobupivacaine Wound Infiltration or Diclofenac for Postoperative Pain Relief
- ClinicalTrials.gov ID
- NCT05829707
- Acronym / sponsor ID
- OsijekUH21
- Conditions
- Postoperative Analgesia, Hand Strength, Health Related Quality of Life, Chronic Shoulder Pain, Breast Cancer Female, Surgical Wound Infiltration
- Keywords
- Acute Postoperative Pain, Breast Cancer, Postoperative analgesia, Patient-Controlled Analgesia, Levobupivacaine, Diclofenac, Hand Grip Strength, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Study start
- 5 Jan 2009 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Diclofenac 2 mg/kg/day - control,
- Wound infiltration via wound catheter with catheter tip placed in the axilla, 3*0.5 mg/kg 0.5% levobupivacaine bolus dose.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diclofenac | Active comparator | Drug: Diclofenac SodiumAll 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. |
| Levobupivacaine bolus analgesia | Experimental | Drug: Levobupivacaine bolus analgesiaGroup 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. |
| Levobupivacaine PCA group | Experimental | Drug: Levobupivacaine PCA groupGroup 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac SodiumAlso: Nonsteroidal antiinflammatory drugA 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 | Diclofenac |
| Levobupivacaine bolus analgesiaAlso: Postoperative wound infiltration with bolus applications of local anesthetic, Chirocaine 0.5%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 bolus analgesia |
| Levobupivacaine PCA groupAlso: Postoperative continuous wound infiltration analgesia with local anesthetic, Chirocaine 0.5%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. | Drug | Levobupivacaine PCA group |
Primary outcome
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.
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.
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.
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).
2 secondary outcomes
Long-term survival - 5 years after surgery
Time frame: Five years after surgery
Long term survival - 10 years after surgery
Time frame: Ten years after surgery until data were collected
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Background: PubMed 32512380Beguinot M, Monrigal E, Kwiatkowski F, Ginzac A, Joly D, Gayraud G, Le Bouedec G, Gimbergues P. Continuous Wound Infiltration With Ropivacaine After Mastectomy: A Randomized Controlled Trial. J Surg Res. 2020 Oct;254:318-326. doi: 10.1016/j.jss.2020.05.006. Epub 2020 Jun 5.
- Background: PubMed 32987492Kaur U, Shamshery C, Agarwal A, Prakash N, Valiveru RC, Mishra P. Evaluation of postoperative pain in patients undergoing modified radical mastectomy with pectoralis or serratus-intercostal fascial plane blocks. Korean J Anesthesiol. 2020 Oct;73(5):425-433. doi: 10.4097/kja.20159. Epub 2020 Sep 24.
- Background: PubMed 29914426Li R, Xiao C, Liu H, Huang Y, Dilger JP, Lin J. Effects of local anesthetics on breast cancer cell viability and migration. BMC Cancer. 2018 Jun 19;18(1):666. doi: 10.1186/s12885-018-4576-2.
- Background: PubMed 36555096Chen JL, Liu ST, Huang SM, Wu ZF. Apoptosis, Proliferation, and Autophagy Are Involved in Local Anesthetic-Induced Cytotoxicity of Human Breast Cancer Cells. Int J Mol Sci. 2022 Dec 7;23(24):15455. doi: 10.3390/ijms232415455.
- Background: PubMed 31541469Castelli V, Piroli A, Marinangeli F, d'Angelo M, Benedetti E, Ippoliti R, Zis P, Varrassi G, Giordano A, Paladini A, Cimini A. Local anesthetics counteract cell proliferation and migration of human triple-negative breast cancer and melanoma cells. J Cell Physiol. 2020 Apr;235(4):3474-3484. doi: 10.1002/jcp.29236. Epub 2019 Sep 20.
- Background: PubMed 32807213Kwakye AK, Kampo S, Lv J, Ramzan MN, Richard SA, Falagan AA, Agudogo J, Atito-Narh E, Yan Q, Wen QP. Levobupivacaine inhibits proliferation and promotes apoptosis of breast cancer cells by suppressing the PI3K/Akt/mTOR signalling pathway. BMC Res Notes. 2020 Aug 17;13(1):386. doi: 10.1186/s13104-020-05191-2.
- Background: PubMed 34002007Klein I, Kalichman L, Chen N, Susmallian S. Effect of physical activity levels on oncological breast surgery recovery: a prospective cohort study. Sci Rep. 2021 May 17;11(1):10432. doi: 10.1038/s41598-021-89908-8.
- Background: PubMed 33067163Meerkerk CDA, Chargi N, de Jong PA, van den Bos F, de Bree R. Sarcopenia measured with handgrip strength and skeletal muscle mass to assess frailty in older patients with head and neck cancer. J Geriatr Oncol. 2021 Apr;12(3):434-440. doi: 10.1016/j.jgo.2020.10.002. Epub 2020 Oct 13.
- Derived from this study: PubMed 37765154Glavas Tahtler J, Djapic D, Neferanovic M, Miletic J, Milosevic M, Kralik K, Neskovic N, Tomas I, Mesaric D, Marjanovic K, Rajc J, Orkic Z, Cicvaric A, Kvolik S. Long-Term Outcomes of Breast Cancer Patients Receiving Levobupivacaine Wound Infiltration or Diclofenac for Postoperative Pain Relief. Pharmaceutics. 2023 Aug 23;15(9):2183. doi: 10.3390/pharmaceutics15092183.
- Individual participant dataSharing planned: No. data may be shared upon request from researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josipa Glavas Tahtler, MD principal investigator
Department of Anaesthesiology, Resuscitation and ICU, Osijek University Hospital,
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac Sodium, Levobupivacaine bolus analgesia and Levobupivacaine PCA group in people with Postoperative Analgesia and Hand Strength, run by Osijek University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesia (time frame: from 1-4 days postoperative, day of surgery is day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05829707, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.