Effect of Noise Blocking During General Anesthesia on Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

Effect of Noise Blocking During General Anesthesia on Postoperative Pain in Patients Undergoing Laparoscopic Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05540691
• Other study ID #: Noise blocking and pain
• Status: Completed
• Phase: N/A
• Start date: October 8, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: December 2022
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the effect of noise blocking during general anesthesia on postoperative pain in patients undergoing laparoscopic abdominal surgery. The aim of this study was to determine whether noise blocking can reduce postoperative pain, analgesic use, and its possible effects on intraoperative electrocorticogram.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA Classification ?-?

• Patients undergoing elective laparoscopic abdominal surgery under general anesthesia

• Voluntarily accept PCIA 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 (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum pain score (NRS score) at 0-24 hours postoperatively	NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful	From ending of the surgery to 24 hours postoperatively
Primary	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
Primary	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 6 hours postoperatively to 12 hours postoperatively
Primary	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
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	Postoperative hyperalgesia after surgery	Postoperative hyperalgesia was measured by the ratio of pressure pain threshold at time when discharged from postanesthesia care unit compare to before surgery	from the 30 minutes before the surgery until to 30 minutes after surgery