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

NCT04611763 | Completed Phase 1

• 1 other identifier: Flurbiprofen axetil
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Postoperative 24 hours pain score

  Use VAS to evaluated postoperative pain score

  24 hours after surgery

• perioperative inflammatory markers

  The 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.

  the day before surgery

• perioperative inflammatory markers

  The 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.

  first day after surgery

• perioperative inflammatory markers

  The 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.

  third day after surgery

Secondary Outcomes (4)

• preoperative sleep quality

  the first night before surgery

• postoperative sleep quality

  the first night after surgery

• postoperative sleep quality

  the third night after surgery

• postoperative adverse effects

  24 hours after surgery

Study Arms (2)

Pre FA Group

EXPERIMENTAL

Drug: Flurbiprofen axetil preoperatively

Post FA Group

ACTIVE COMPARATOR

Drug: Flurbiprofen axetil postoperatively

Interventions

Flurbiprofen axetil preoperatively DRUG

give Flurbiprofen axetil 15 min before surgery

Pre FA Group

Flurbiprofen axetil postoperatively DRUG

give Flurbiprofen axetil at the end of surgery

Post FA Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

beijing friendship hospital of Capital Medical university

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 41126955 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 2, 2020
• Study Start: September 1, 2021
• Primary Completion: October 10, 2023
• Study Completion: February 1, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)