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Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Laparoscopic Gynecological Surgery.

Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Laparoscopic Gynecological Surgery.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04611763
Enrollment
112
Registered
2020-11-02
Start date
2021-09-01
Completion date
2024-02-01
Last updated
2025-07-24

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

Conditions

Flurbiprofen Axetil, Perioperative Sleep Quality, Postoperative Inflammatory Markers, Postoperative Pain, Preemptive Analgesia

Brief summary

In humans and animals, circadian rhythm sleep cycle is an important function to maintain and regulate basic physiological homeostasis, such as cognitive function, glucose metabolism, memory consolidation, immune function and growth hormone secretion. The induction of general anesthesia leads to a state of reduced responsiveness, which is often described by anesthesiologists and patients as sleep. However, previous studies have shown that in the case of patients under general anesthesia, besides surgery trauma and general anesthetics may change sleep function and sleep cycle perioperatively, the postoperative complications such as pain, nausea and vomitting etc after general anesthesia may also reduce postoperative sleep quality.Meanwhile, there is a mixed literature linking sleep and markers of systemic inflammation that greater sleep disturbances were associated with higher levels of circulating IL-6 and CRP but not TNF-α. And the effects of inflammatory cytokines may also cause changes in sleep patterns. Flurbiprofen axetil is a new non-steroidal anti infection analgesic(NSAIDs), which is widely used for analgesia to reduce the dose of opioids. It not only has a high affnity for infammatory tissues to achieve targeted drug therapy and prolonged duration of action, but causes analgesia effect through decreasing the biological production of prostaglandins, reducing the reactivity of peripheral nerves to endogenous infammatory factors, and inhibiting the sensitization of central as well as peripheral nervous systems.Furthermore, it could also inhibite the occurrence of adverse reactions, such as declined sleep quality, respiratory depression, nausea and vomiting. Preemptive analgesia is an analgesic intervention that begins before surgery to prevent the nervous system from becoming sensitive to subsequent stimuli that may aggravate pain. A large number of experimental studies have shown that the use of local anesthetics and/or analgesics in advance can prevent central nervous system hyperplasia, thereby reducing postoperative pain. The aim of our study was to investigate the effect of preemptive analgesic with flurbiprofen axetil on postoperative pain, inflammatory markers and sleep quality among patients under general anesthesia. We hypothesized that use flurbiprofen axetil preoperatively would effectively relieve postoperative pain, inhibite inflammtory reaction and improve postoperative sleep quality.

Interventions

DRUGFlurbiprofen axetil preoperatively

give Flurbiprofen axetil 15 min before surgery

DRUGFlurbiprofen axetil postoperatively

give Flurbiprofen axetil at the end of surgery

Sponsors

Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

age: 18-75 ASA: I-II Receive operation under general anesthesia

Exclusion criteria

* ①Patients with mental illness; * Severe sleep disorders in the past; * A history of taking opioids; * Patients who are allergic to the drug * Patients who have difficulty communicating and refuse to participate in the trial.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative 24 hours pain score24 hours after surgeryUse VAS to evaluated postoperative pain score
perioperative inflammatory markersthe day before surgeryThe inflammtory markers such as system inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), and monocyte-to-lymphocyte ratio (MLR) were recorded before and after surgery. SII= platelet count × neutrophil count/lymphocyte count, NLR= neutrophil count/lymphocyte count, MLR= monocyte count/lymphocyte count.

Secondary

MeasureTime frameDescription
preoperative sleep qualitythe first night before surgeryevaluate postoperative sleep quality at the first night before surgery
postoperative sleep qualitythe first night after surgeryevaluate postoperative sleep quality at the first night after surgery
postoperative adverse effects24 hours after surgeryevaluate postoperative adverse effects

Countries

China

Outcome results

None listed

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