Effect of Noise Isolation on the Incidence of Moderate to Severe Postoperative Pain

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Device: Wear noise-cancelling earphones

• Registration Number: NCT06316440
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-12
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-18
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Noise-canceling Group	Wear noise-cancelling earphones	Intraoperative intervention with noise-canceling earphones was performed to isolate the noise

Primary Outcome Measures

Name	Time	Method
The incidence of moderate to severe postoperative pain	From ending of the surgery to 24 hours postoperatively	Moderate to severe postoperative pain：NRS score ≥ 4 (Pain was assessed using NRS scale of 0-10, with 0 being no pain and 10 being most painful)

Secondary Outcome Measures

Name	Time	Method
Maximum pain score (NRS score) at 0-48 hours postoperatively	From ending of the surgery to 48 hours postoperatively	NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Patient controlled analgesia pump analgesic consumption	From the time when the surgery was completed until to 48 hours after surgery	Analgesic requirements was assessed by recording the volume of patient controlled analgesia pump
Accumulative postoperative pain NRS	From ending of the surgery to 48 hours postoperatively	Accumulative NRS score (Pain was assessed using NRS scale of 0-10, with 0 being no pain and 10 being most painful) at 6, 12, 24 and 48 hours after surgery
The incidence of additional analgesic requirements	From the time when the surgery was completed until to 48 hours after surgery	the percentage of patients who received additional analgesic out of the total number of patients in the group
The incidence of moderate to severe postoperative pain	From ending of the surgery to 48 hours postoperatively	Moderate to severe postoperative pain：NRS score ≥ 4 (Pain was assessed using NRS scale of 0-10, with 0 being no pain and 10 being most painful)

Trial Locations

Locations (1)

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China