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

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.

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Key information

Conditions

Sleep Quality Anesthesia Techniques Dyssomnias Mental Disorders Nervous System Diseases Postoperative Recovery Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regional Analgesic Block

Other

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).

Primary outcomes

Postoperative Sleep Quality Measured by RCSQ

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ilke dolgun

CONTACT

[email protected]

+905555485632

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

Sleep During Recovery: Does Preoperative Regional Block Affect Postoperative Sleep Quality in Mastectomy Patients? A Prospective Evaluation Using Two Validated Sleep Quality Scales

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 4, 2025
Registry last updated: Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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