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

NCT ID: NCT07051434

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-02-01

Brief Summary

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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

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Conditions

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Sleep Quality Postoperative Recovery Anesthesia Techniques

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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General Anesthesia Only (GA)

Patients undergoing mastectomy with general anesthesia alone.

Regional Analgesic Block

Intervention Type 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).

General Anesthesia + Regional Block (GA+RB)

Patients receiving both general anesthesia and regional analgesic block.

Regional Analgesic Block

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istinye University

OTHER

Sponsor Role lead

Responsible Party

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İlke Dolgun

Assoc. prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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ilke dolgun

Role: CONTACT

+905555485632

References

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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.

Reference Type RESULT
PMID: 36652140 (View on PubMed)

Wang H, et al. Regional Block Anesthesia in Breast Surgery: What Do We Know So Far? Open Journal of Anesthesiology. 2024;14:185-195.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 38242803 (View on PubMed)

Other Identifiers

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mastektomi rcsq

Identifier Type: -

Identifier Source: org_study_id

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