Sleep During Recovery: Effect of Preoperative Regional Block on Postoperative Sleep Quality in Mastectomy Patients

ConditionsSleep Quality Postoperative Recovery Anesthesia Techniques

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorIstinye University

About this trial

This prospective observational study investigates the impact of preoperative regional anesthesia on postoperative sleep quality in patients undergoing mastectomy. Sleep quality will be assessed using two validated tools: the Richards-Campbell Sleep Questionnaire (RCSQ) for all participants, and the Pittsburgh Sleep Quality Index (PSQI) in a subgroup. The study also examines the relationship between sleep quality and postoperative pain, patient satisfaction, and psychological status measured by the Hospital Anxiety and Depression Scale (HADS). Patients will be grouped based on anesthesia technique-general anesthesia alone or general anesthesia combined with regional block-and sleep outcomes will be compared. The study aims to provide evidence on how anesthetic technique and psychological factors affect recovery and sleep quality after breast cancer surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18 years or older

Undergoing elective mastectomy surgery

ASA physical status I to III

Willing and able to provide written informed consent

Disqualifiers

History of major psychiatric or neurological disorders

Regular use of antidepressants, anxiolytics, or hypnotics

Difficult airway management during anesthesia (e.g., intubation or ventilation complications)

Reoperation within the first 24 hours after surgery

Trial population

The study population will consist of adult female patients (≥18 years old) scheduled for elective mastectomy surgery at a single academic hospital

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Regional Analgesic Block
Other intervention
Preoperative regional analgesic block performed as part of routine clinical care in selected patients undergoing mastectomy (e.g., PECS block, paravertebral block, or other truncal blocks).

Treatment groups

66 Participants

are divided into 2 treatment groups

Group A: General Anesthesia Only (GA)1 intervention

Group B: General Anesthesia + Regional Block (GA+RB)1 intervention

Trial outcomes

Primary outcomes

Postoperative Sleep Quality Measured by RCSQ

Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ) on the first morning after surgery. The total score ranges from 0 (poor sleep) to 100 (excellent sleep). Comparison will be made between patients receiving general anesthesia alone and those receiving general anesthesia combined with regional block.

Time frame

Postoperative Day 1 (the morning after surgery)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istinye University

Lead sponsor

Haseki Training and Research Hospital

Sponsor institution

Source ClinicalTrials.gov

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