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RECRUITING Not applicable ClinicalTrials.gov

Comparison of Two Postoperative Care Strategies After Breast Surgery

Sponsor: Moumtzidou Maria Aikaterini • ClinicalTrials.gov ID: NCT07880223

Registry updated: 2026-10-20
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Description

The goal of this clinical trial is to compare two postoperative analgesia strategies in adult women undergoing breast surgery and to evaluate their effects on postoperative pain and quality of recovery after hospital discharge. The main questions it aims to answer are: * Does a patient education-based analgesia strategy improve postoperative pain control compared with standard analgesic management? * Does the patient education-based strategy improve quality of recovery after hospital discharge? Researchers will compare the patient education group with the standard care group to assess differences in postoperative pain intensity and quality of recovery. Participants will: * Receive either a patient education-based postoperative analgesia strategy or standard postoperative analgesic management. * Complete questionnaires assessing pain, quality of recovery, and other aspects of health at specified time points. * Be followed for 90 days after surgery.

Interventions

  • Patient Education (Behavioral)
    Structured patient education regarding postoperative pain management, including discussion of the analgesic strategy and appropriate use of pharmacological and non-pharmacological pain management measures.
  • Paracetamol (Drug)
    Paracetamol 1 g orally three times daily (3 g/day)
  • Dexketoprofen (Drug)
    Dexketoprofen 50 mg is administered intravenously every 12 hours during the first 48 hours postoperatively. It is then switched to oral dexketoprofen 25 mg every 12 hours for 3 days, followed by use as needed for pain until 7-14 days after surgery.
  • Pregabalin (Drug)
    Pregabalin 25-75 mg is administered orally every 12 hours for 30 days as part of the multimodal postoperative analgesic regimen
  • Tramadol (Drug)
    Tramadol 50-100 mg IV postoperatively as rescue therapy (maximum dose 300 mg/day). If the patient received tramadol during the postoperative period, oral tramadol 50 mg was continued as needed for pain for 4-7 days (maximum daily dose 300 mg)

Eligibility criteria

Inclusion Criteria: * Age ≥ 18 years * ASA physical status classification I-III * Provision of written informed consent * Ability to be contacted by telephone Exclusion Criteria: * Hypersensitivity to any of the medications used in the study * Severe hepatic or renal dysfunction * Pregnancy * History of epileptic seizures * Severe psychiatric disorder (e.g., active psychosis or severe depression) affecting their ability to cooperate * Underwent a second surgical procedure before completion of the 3-month follow-up period

Conditions

Postoperative Pain Pain Management Breast Surgery Chronic Postoperative Pain

Locations

  • University General Hospital of Heraklion (PAGNI) — Heraklion, Crete, Greece
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record