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

Not yet recruiting

• Conditions: Sleep Quality; Postoperative Recovery; Anesthesia Techniques

• Registration Number: NCT07051434
• Lead Sponsor: Istinye University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study Start: 2025-07-01
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04
• Primary Completion: 2026-01-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• 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
• Expected to remain hospitalized for at least 24 hours postoperatively

Exclusion Criteria

• 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
• Inability to complete questionnaires due to deep sedation or visual/auditory impairment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative Sleep Quality Measured by RCSQ	Postoperative Day 1 (the morning after surgery)	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.