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Not yet recruiting NCT07051434

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

— Observational Sleep Quality Postoperative Recovery Anesthesia Techniques

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Regional Analgesic Block.
Who it may be relevant to
Registry conditions: Sleep Quality, Postoperative Recovery, Anesthesia Techniques. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Regional 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).

Primary outcome measures

  • Postoperative Sleep Quality Measured by RCSQ [Time frame: Postoperative Day 1 (the morning after surgery)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Yang RZ, Li YZ, Liang M, Yu JJ, Chen ML, Qiu JJ, Lin SZ, Wu XD, Zeng K. Stellate Ganglion Block Improves Postoperative Sleep Quality and Analgesia in Patients with Breast Cancer: A Randomized Controlled Trial. Pain Ther. 2023 Apr;12(2):491-503. doi: 10.1007/s40122-022-00473-y. Epub 2023 Jan 18. PMID 36652140
  • Wang H, et al. Regional Block Anesthesia in Breast Surgery: What Do We Know So Far? Open Journal of Anesthesiology. 2024;14:185-195.
  • Ni Eochagain A, Carolan S, Buggy DJ. Regional anaesthesia truncal blocks for acute postoperative pain and recovery: a narrative review. Br J Anaesth. 2024 May;132(5):1133-1145. doi: 10.1016/j.bja.2023.12.020. Epub 2024 Jan 19. PMID 38242803

Identifiers

NCT: NCT07051434 · mastektomi rcsq

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗