Perioperative pruritus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients aged 18-70 years undergoing lower limb fracture surgery. (2) Patients with ASA physical status classification I-III. (3) Patients receiving spinal anesthesia with fentanyl combined with bupivacaine. (4)The study protocol was approved by the Ethics Committee, and written informed consent was obtained from all participants.
Exclusion criteria
Exclusion criteria: (1) The patient declined to participate in this trial; (2) Patients with diabetes mellitus or pruritic conditions; (3) Patients with spinal deformities or local infection at the puncture site; (4) Patients with coagulation disorders, or hepatic, renal, cardiac, or pulmonary insufficiency; (5) Patients with tolerance, allergy, or a history of adverse reactions to the investigational drugs; (6) Patients with a history of dementia or psychiatric disorders, or current use of sedatives or antidepressants; (7) Patients with severe visual or hearing impairment; (8) Patients deemed ineligible for this study by the attending physician or investigator for other reasons, which must be documented; (9) Patients concurrently participating in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pruritus; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative vital signs;Intraoperative core body temperature;Ramsay Sedation Scale scores from intraoperative period to 24 hours after surgery;VAS analgesic scores from intraoperative period to 24 hours after surgery;Adverse reactions from intraoperative period to 24 hours after surgery;Quality of Recovery-15 (QoR-15) scores at 24 hours after surgery;Duration of sensory and motor block of the lower extremities after surgery; | — |
Countries
China
Contacts
Ningxia Hui Autonomous Region People's Hospital