Effect of Noise Blocking During General Anesthesia on Postoperative Pain

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA Classification ⅰ-ⅲ
• 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

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: group 1; 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: group 2; 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
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
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 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
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 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
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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Study Chair: Huang He, doctor, Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative Pain; noise blocking
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Noise blocking and 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
• product manufactured in and exported from the U.S.: No