An interventional study of Patient Education and Paracetamol in Postoperative Pain, Pain Management and Breast Surgery, sponsored by Moumtzidou Maria Aikaterini. Recruiting at 1 site in Greece. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Moumtzidou Maria Aikaterini · Not applicable, Interventional, and Treatment
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:
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:
Postoperative pain following breast surgery can negatively affect patients' recovery and overall experience after hospital discharge. Effective postoperative analgesia may require not only appropriate pharmacological treatment but also adequate patient education regarding pain management and the use of non-pharmacological measures.
This pilot prospective randomized clinical trial is designed to evaluate whether a comprehensive postoperative analgesia strategy incorporating patient education can improve pain control and quality of recovery compared with standard postoperative analgesic management in adult women undergoing breast surgery.
The intervention strategy combines patient education, discussion of postoperative pain management, non-pharmacological measures, and a multimodal pharmacological analgesic regimen. The control strategy consists of standard postoperative analgesic management and written postoperative instructions.
Participants will be followed from the preoperative period through 90 days after surgery to evaluate postoperative pain, quality of recovery, and other patient-reported outcomes.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 108 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with Moumtzidou Maria Aikaterini as lead sponsor.
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Exclusion Criteria:
Participants will receive a comprehensive postoperative analgesia strategy including patient education and discussion regarding pain management, non-pharmacological measures, and multimodal pharmacological analgesia with paracetamol, dexketoprofen, and pregabalin.
Behavioral: Patient Education · Drug: Paracetamol · Drug: Dexketoprofen · Drug: Pregabalin · Drug: Tramadol
Participants will receive standard postoperative analgesic management with written postoperative instructions and paracetamol.
Drug: Paracetamol · Drug: Tramadol
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 1 g orally three times daily (3 g/day)
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 25-75 mg is administered orally every 12 hours for 30 days as part of the multimodal postoperative analgesic regimen
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)
Postoperative Pain Intensity
Postoperative pain intensity assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain)
Time frame: Postoperative day 1, day 7, 1 month, and 3 months after surgery
Quality of Recovery
Quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Total scores range from 0 to 150, with higher scores indicating better quality of recovery
Time frame: Postoperative day 1
Incidence of Chronic Neuropathic Pain
Incidence of chronic neuropathic pain assessed using the PainDETECT questionnaire
Time frame: Preoperatively, 1 month, and 3 months after surgery
Patients' Emotional Status
Assessment of patients' emotional status using the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Preoperatively
Incidence of Postoperative Opioid Use
Postoperative opioid use recorded as a binary variable (yes/no), indicating whether participants received opioids for postoperative pain management during hospitalization
Time frame: From surgery through 3 months postoperatively
Incidence of Adverse Events
Incidence of adverse events associated with the postoperative analgesic regimens, including dizziness, nausea, vomiting, and other adverse effects reported or observed during the study
Time frame: From surgery through 3 months postoperatively
Plan to share: No
Started Oct 2026 (actual). Primary completion is estimated for Aug 2027, 10 months after the start.
Of 1,888 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 10 months is close to that.
Counting every sponsor, half of 1,901 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Dexketoprofen · Pregabalin