The Impact of Patient Education on Postoperative Analgesia Strategy and Its Effect on Pain Intensity and Quality of Recovery After Hospital Discharge: A Pilot Prospective Randomized Controlled Trial
| Registry | NCT07880223 |
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 108 (Estimated) |
| Sponsor | Moumtzidou Maria Aikaterini (Other) |
| Conditions | Postoperative Pain, Pain Management, Breast Surgery, Chronic Postoperative Pain |
| Interventions | Patient Education, Paracetamol, Dexketoprofen, Pregabalin, Tramadol (Behavioral, drug) |
| Dates | start 2026-10-19, primary completion 2027-08-01 (estimated), completion 2027-11-01 (estimated), first posted 2026-10-19, last updated 2026-10-20 |
| Locations | 1 site in Greece |
Related Papers Related Patents Related Grants Related Experts
All trials for Postoperative Pain All trials for Pain Management All trials of Patient Education All trials of Paracetamol
-Summary
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.
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+Detailed description
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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Patient Education-Based Analgesia | Experimental | Behavioral: Patient Education; Drug: Paracetamol; Drug: Dexketoprofen; Drug: Pregabalin; Drug: Tramadol | 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. |
| Standard Analgesia | Active comparator | Drug: Paracetamol; Drug: Tramadol | Participants will receive standard postoperative analgesic management with written postoperative instructions and paracetamol. |
- 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)
+Outcome measures
Primary outcomes
- Postoperative Pain Intensity [Postoperative day 1, day 7, 1 month, and 3 months after surgery]: Postoperative pain intensity assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain)
- Quality of Recovery [Postoperative day 1]: 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
Secondary outcomes
- Incidence of Chronic Neuropathic Pain [Preoperatively, 1 month, and 3 months after surgery]: Incidence of chronic neuropathic pain assessed using the PainDETECT questionnaire
- Patients' Emotional Status [Preoperatively]: Assessment of patients' emotional status using the Patient Health Questionnaire-9 (PHQ-9)
- Incidence of Postoperative Opioid Use [From surgery through 3 months postoperatively]: Postoperative opioid use recorded as a binary variable (yes/no), indicating whether participants received opioids for postoperative pain management during hospitalization
- Incidence of Adverse Events [From surgery through 3 months postoperatively]: Incidence of adverse events associated with the postoperative analgesic regimens, including dizziness, nausea, vomiting, and other adverse effects reported or observed during the study
+Eligibility
Sex: Female, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
|---|
| University General Hospital of Heraklion (PAGNI) | Heraklion, Crete | Greece | Recruiting |
+Publications
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- Gildemyn H. [Perforating wounds of the cornea with prolapse of the iris; treatment without iridectomy]. Bull Soc Belge Ophtalmol. 1982;201:33-9. No abstract available. French. PMID 7187257
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- Chang PJ, Asher A, Smith SR. A Targeted Approach to Post-Mastectomy Pain and Persistent Pain following Breast Cancer Treatment. Cancers (Basel). 2021 Oct 16;13(20):5191. doi: 10.3390/cancers13205191. PMID 34680339
- Wang L, Cohen JC, Devasenapathy N, Hong BY, Kheyson S, Lu D, Oparin Y, Kennedy SA, Romerosa B, Arora N, Kwon HY, Jackson K, Prasad M, Jayasekera D, Li A, Guarna G, Natalwalla S, Couban RJ, Reid S, Khan JS, McGillion M, Busse JW. Prevalence and intensity of persistent post-surgical pain following breast cancer surgery: a systematic review and meta-analysis of observational studies. Br J Anaesth. 2020 Sep;125(3):346-357. doi: 10.1016/j.bja.2020.04.088. Epub 2020 Jun 28. PMID 32611524
- Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. PMID 19903919
- El-Boghdadly K, Levy NA, Fawcett WJ, Knaggs RD, Laycock H, Baird E, Cox FJ, Eardley W, Kemp H, Malpus Z, Partridge A, Partridge J, Patel A, Price C, Robinson J, Russon K, Walumbe J, Lobo DN. Peri-operative pain management in adults: a multidisciplinary consensus statement from the Association of Anaesthetists and the British Pain Society. Anaesthesia. 2024 Nov;79(11):1220-1236. doi: 10.1111/anae.16391. Epub 2024 Sep 25. PMID 39319373
- Park R, Mohiuddin M, Arellano R, Pogatzki-Zahn E, Klar G, Gilron I. Prevalence of postoperative pain after hospital discharge: systematic review and meta-analysis. Pain Rep. 2023 May 8;8(3):e1075. doi: 10.1097/PR9.0000000000001075. eCollection 2023 May-Jun. PMID 37181639