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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06316440
• Other study ID #: noise and postoperative pain
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Guangyou Duan, Doctor
• Phone: (+86)18323376014
• Email: duangy[@]hospital.cqmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• Wear noise-cancelling earphones
Intervention of wearing noise-canceling earphones after general anesthesia

Locations

Country	Name	City	State
China	Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing

Sponsors (6)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University	Chongganng General Hospital, Shapingba People's Hospital of Chongqing University, The First Affiliated Hospital of Zhengzhou University, Tongji Hospital, Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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