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

The Second Affiliated Hospital of Chongqing Medical University304 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

304

Conditions

Postoperative Pain

Interventions

Wear noise-cancelling earphonesDEVICE

Intervention of wearing noise-canceling earphones after general anesthesia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: From ending of the surgery to 24 hours postoperatively

Secondary Outcomes

Patient controlled analgesia pump analgesic consumption

Analgesic requirements was assessed by recording the volume of patient controlled analgesia pump

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: From ending of the surgery to 48 hours postoperatively

Central Contacts

Guangyou Duan, Doctor

CONTACT

(+86)18323376014 duangy@hospital.cqmu.edu.cn

Data from ClinicalTrials.gov

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