Clinical trial · Interventional
Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia
Long-term Outcomes of Breast Cancer Patients Receiving Levobupivacaine Wound Infiltration or Diclofenac for Postoperative Pain Relief
NCT05829707CI-TRIAL-00066053completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Chronic Shoulder Pain | — | UNRESOLVED | — |
| Hand Strength | — | UNRESOLVED | — |
| Health Related Quality of Life | — | UNRESOLVED | — |
| Lymph Node Dissection | — | UNRESOLVED | — |
| Postoperative Analgesia | — | UNRESOLVED | — |
| Surgical Wound Infiltration | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diclofenac Sodium | Drug | — | UNRESOLVED |
| Levobupivacaine bolus analgesia | Drug | — | UNRESOLVED |
| Levobupivacaine PCA group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Diclofenac
- 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.
- interventionNames
- Drug: Diclofenac Sodium
- type
- EXPERIMENTAL
- label
- Levobupivacaine bolus analgesia
- 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.
- interventionNames
- Drug: Levobupivacaine bolus analgesia
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDBeguinot 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. PMID 32512380
- BACKGROUNDKaur 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. PMID 32987492
- BACKGROUNDLi 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. PMID 29914426
- BACKGROUNDChen 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. PMID 36555096
- BACKGROUNDCastelli 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. PMID 31541469
- BACKGROUNDKwakye 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. PMID 32807213
- BACKGROUNDKlein 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.