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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07051434
Enrollment
66
Registered
2025-07-04
Start date
2025-07-01
Completion date
2026-02-01
Last updated
2025-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Techniques, Postoperative Recovery, Sleep Quality

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.

Interventions

OTHERRegional Analgesic Block

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).

Sponsors

Istinye University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Sleep Quality Measured by RCSQPostoperative 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.

Contacts

Primary Contactilke dolgun
ilkeser2004@gmail.com+905555485632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026