Clinical trial NCT06316440: Effect of Noise Isolation on the Incidence of Moderate to Severe Postoperative Pain
Official title: Effect of Noise Isolation During General Anesthesia on the Incidence of Moderate to Severe Postoperative Pain in Patients Undergoing Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: noise Isolation
major abdominal surgery
postoperative Pain
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: Shapingba People's Hospital of Chongqing University
name: The 3rd. Affiliated Hospital of Chongqing Medical University
name: Chongqing Hechuan District People's Hospital
name: Chongqing Qijiang District People's Hospital
name: ChongGang General Hospital
First posted: 2024-03-18
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly divided into intervention group（noise blocking） and control group（No noise blocking）
Primary purpose: TREATMENT

Brief summary: To investigate the effect of noise isolation during general anesthesia on the incidence of moderate to severe postoperative pain in patients undergoing major abdominal surgery. The aim of this study was to determine whether noise isolation can reduce the Incidence of moderate to severe postoperative pain and analgesic use.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 70, both male and female.
* American Society of Anesthesiologists Classification 1-3
* Patients undergoing elective major abdominal surgery under general anesthesia(Surgery time ≥ 2h)
* Voluntarily accept patient controlled intravenous analgesia and signed informed consent

Exclusion Criteria:

* Patients with previous severe disease
* Patients with hearing abnormalities
* Patients requiring mechanical ventilation or undergoing epidural catheters or other types of regional anesthesia after surgery
* Patients with chronic preoperative pain and/or long-term analgesic use
* Patients who could not cooperate with the study for any reason

Primary outcomes:
measure: The incidence of moderate to severe postoperative pain
timeFrame: From ending of the surgery to 24 hours postoperatively
Secondary outcomes:
measure: Patient controlled analgesia pump analgesic consumption
timeFrame: From the time when the surgery was completed until to 24 hours after surgery
measure: Patient controlled analgesia pump analgesic consumption
timeFrame: From the time when the surgery was completed until to 48 hours after surgery
measure: The incidence of additional analgesic requirements
timeFrame: From the time when the surgery was completed until to 48 hours after surgery
measure: Maximum pain score (NRS score) at 0-48 hours postoperatively
timeFrame: From ending of the surgery to 48 hours postoperatively
measure: The incidence of moderate to severe postoperative pain
timeFrame: From ending of the surgery to 48 hours postoperatively
measure: Accumulative postoperative pain NRS
timeFrame: From ending of the surgery to 48 hours postoperatively
Other outcomes:
measure: Pain score (NRS score) at 0-6 hours postoperatively
timeFrame: From ending of the surgery to 6 hours postoperatively
measure: Pain score (NRS score) at 6-12 hours postoperatively
timeFrame: From ending of the surgery to 12 hours postoperatively
measure: Pain score (NRS score) at 12-24 hours postoperatively
timeFrame: From 12 hours postoperatively to 24 hours postoperatively
measure: Pain score (NRS score) at 24-48 hours postoperatively
timeFrame: From 24 hours postoperatively to 48 hours postoperatively
Locations:
city: Chongqing
country: China
facility: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
name: Guangyou Duan, Doctor
role: STUDY_CHAIR
References: