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

Effect of Noise Isolation During General Anesthesia on the Incidence of Moderate to Severe Postoperative Pain in Patients Undergoing Major Abdominal Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: Wear noise-cancelling earphones

• Study Type: Interventional
• Enrollment (Estimated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guangyou Duan, Doctor; Phone Number: (+86)18323376014; Email: duangy@hospital.cqmu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Recruiting
      • Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
      • Contact: Guangyou Duan, MD; Phone Number: (+86)18323376014; Email: duangy@hospital.cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• American Society of Anesthesiologists Classification 1-3
• Patients undergoing elective major abdominal surgery under general anesthesia
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Noise-canceling Group; Intraoperative intervention with noise-canceling earphones was performed to isolate the noise	Device: Wear noise-cancelling earphones; Intervention of wearing noise-canceling earphones after general anesthesia
No Intervention: Control Group; After general anesthesia, the intervention of wearing noise-canceling earphones was not given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of moderate to severe postoperative pain	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)	From ending of the surgery to 24 hours postoperatively

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score (NRS score) at 0-6 hours postoperatively	NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful	From ending of the surgery to 6 hours postoperatively
Pain score (NRS score) at 12-24 hours postoperatively	NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful	From 12 hours postoperatively to 24 hours postoperatively
Pain score (NRS score) at 6-12 hours postoperatively	NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful	From ending of the surgery to 12 hours postoperatively
Pain score (NRS score) at 24-48 hours postoperatively	NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful	From 24 hours postoperatively to 48 hours postoperatively

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Collaborators: Wuhan University; Tongji Hospital; The First Affiliated Hospital of Zhengzhou University; Shapingba People's Hospital of Chongqing University; Chongganng General Hospital
• Investigators: Study Chair: Guangyou Duan, Doctor, Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: major abdominal surgery; postoperative Pain; noise Isolation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: noise and postoperative pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data for this study is available from the sponsor on reasonable request through email
• IPD Sharing Time Frame: Five years after the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No