Postoperative PainNCT07880223
Comparison of Two Postoperative Care Strategies After Breast Surgery
A study testing Patient Education, Paracetamol and Dexketoprofen in people with Postoperative Pain and Pain Management, run by Moumtzidou Maria Aikaterini at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain, Pain Management, Breast Surgery
- What is being tested?
- Patient Education, Paracetamol and Dexketoprofen
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteGreece
- Study dates
- 19 Oct 2026to Nov 2027
- Phase
- Interventional
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- ASA physical status classification I-III
- Provision of written informed consent
- Ability to be contacted by telephone
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University General Hospital of Heraklion (PAGNI)
Heraklion, Crete, 71305
Maria Aikaterini Moumtzidou, MD, +30 6944798447, maritina_moumtzidou@hotmail.com
About this study
Official title: 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
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:
Read more
- 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.
Read the 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.
- Being tested
- Patient Education, Paracetamol, Dexketoprofen, Pregabalin, Tramadol
- Keywords
- Pain Management, Patient Education, Postoperative analgesia, Multimodal analgesia, Postoperative pain, Breast surgery, Chronic postsurgical pain, Quality of Recovery, Neuropathic pain
- Medical subject headings
- Pain, Postoperative, Agnosia, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient EducationBehavioural
Structured patient education regarding postoperative pain management, including discussion of the analgesic strategy and appropriate use of pharmacological and non-pharmacological pain management measures.
ParacetamolDrug
Paracetamol 1 g orally three times daily (3 g/day)
DexketoprofenDrug
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.
PregabalinDrug
Pregabalin 25-75 mg is administered orally every 12 hours for 30 days as part of the multimodal postoperative analgesic regimen
TramadolDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Patient Education-Based Analgesia | Experimental | 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. Receives: Behavioral: Patient Education; Drug: Paracetamol; Drug: Dexketoprofen; Drug: Pregabalin; Drug: Tramadol |
| Standard Analgesia | Active comparator | Participants will receive standard postoperative analgesic management with written postoperative instructions and paracetamol. Receives: Drug: Paracetamol; Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: 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
Measured: Postoperative day 1
Secondary outcomes (4)
Incidence of Chronic Neuropathic Pain
Incidence of chronic neuropathic pain assessed using the PainDETECT questionnaire
Measured: Preoperatively, 1 month, and 3 months after surgery
Patients' Emotional Status
Assessment of patients' emotional status using the Patient Health Questionnaire-9 (PHQ-9)
Measured: 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
Measured: 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
Measured: From surgery through 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start19 Oct 2026
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moumtzidou Maria Aikaterini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moumtzidou Maria Aikaterini, University General Hospital of Heraklion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880223
- Sponsor's protocol ID
- 24138/08-07-2025
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali Z, Ahsan Z, Liaqat N, Din IU. Bridging the gap: evaluation of preoperative patients' education by comparing expectations and real-perioperative surgical experiences: a mixed-methods descriptive cross-sectional study. BMC Health Serv Res. 2024 Aug 21;24(1):964. doi: 10.1186/s12913-024-11388-z.
PubMed 39169337Gildemyn 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.
PubMed 7187257Clarke HA, Manoo V, Pearsall EA, Goel A, Feinberg A, Weinrib A, Chiu JC, Shah B, Ladak SSJ, Ward S, Srikandarajah S, Brar SS, McLeod RS. Consensus Statement for the Prescription of Pain Medication at Discharge after Elective Adult Surgery. Can J Pain. 2020 Mar 8;4(1):67-85. doi: 10.1080/24740527.2020.1724775.
PubMed 33987487Brenin DR, Dietz JR, Baima J, Cheng G, Froman J, Laronga C, Ma A, Manahan MA, Mariano ER, Rojas K, Schroen AT, Tiouririne NA, Wiechmann LS, Rao R. Pain Management in Breast Surgery: Recommendations of a Multidisciplinary Expert Panel-The American Society of Breast Surgeons. Ann Surg Oncol. 2020 Nov;27(12):4588-4602. doi: 10.1245/s10434-020-08892-x. Epub 2020 Aug 11.
PubMed 32783121Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
PubMed 26827847Chang 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.
PubMed 34680339Wang 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.
PubMed 32611524Gartner 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.
PubMed 19903919El-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.
PubMed 39319373Park 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.
PubMed 37181639