NCT07069322

Brief Summary

To evaluate the effect of regional analgesic blocks (TAP or rectus sheath block) applied in addition to general anesthesia on postoperative sleep quality in patients undergoing total abdominal hysterectomy (RCSQ score).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

July 25, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 7, 2025

Last Update Submit

July 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Richards-Campbell Sleep Questionnaire Score (RCSQ)

    Clinically ≥50 points: good/moderate sleep quality, \<50 points: poor sleep quality

    Postoperative 24 hours

Study Arms (2)

With Regional

Those who underwent regional analgesic block (GA+RB) in addition to general anesthesia.

Behavioral: Richards-Campbell Sleep Questionnaire (RCSQ)

Without Regional

Those under general anesthesia (GA)

Behavioral: Richards-Campbell Sleep Questionnaire (RCSQ)

Interventions

\- Score 0 = Very poor sleep, 100 = Very good sleep

With RegionalWithout Regional

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women between the ages of 18 and 70 who will undergo TAH operation under general anesthesia.

You may qualify if:

  • Elective TAH planned
  • ASA I-III group
  • Female patients aged 18-70 years
  • Those who are planned to be hospitalized at least one night in the postoperative period
  • Those who have the cognitive capacity to understand and answer the questionnaire

You may not qualify if:

  • Patients with a history of neurological or psychiatric disease
  • Patients diagnosed with sleep disorders
  • Patients with sedative/hypnotic drug use
  • Patients requiring additional surgical intervention during the operation
  • Patients admitted to intensive care unit
  • Patients operated with epidural or spinal anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 16, 2025

Study Start

July 25, 2025

Primary Completion

November 25, 2025

Study Completion

December 25, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07