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

NCT ID: NCT04611763

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-02-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pre FA Group

Group Type: EXPERIMENTAL

Flurbiprofen axetil preoperatively

Intervention Type: DRUG

give Flurbiprofen axetil 15 min before surgery

Post FA Group

Group Type: ACTIVE_COMPARATOR

Flurbiprofen axetil postoperatively

Intervention Type: DRUG

give Flurbiprofen axetil at the end of surgery

Interventions

Flurbiprofen axetil preoperatively

give Flurbiprofen axetil 15 min before surgery

Intervention Type: DRUG

Flurbiprofen axetil postoperatively

give Flurbiprofen axetil at the end of surgery

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bijia Song

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

beijing friendship hospital of Capital Medical university

Beijing, , China

Countries

China

References

Huang X, Wei W, Leng Z, Song B, Fu M, He J, Zhu J. Preemptive flurbiprofen axetil for sleep-pain-inflammation modulation after laparoscopic gynecological surgery: a prospective, parallel-group randomized controlled trial. Front Pharmacol. 2025 Oct 7;16:1659179. doi: 10.3389/fphar.2025.1659179. eCollection 2025.

Reference Type: DERIVED

PMID: 41126955 (View on PubMed)

Other Identifiers

Flurbiprofen axetil

Identifier Type: -

Identifier Source: org_study_id