Back to resultsEffect of Noise Blocking During General Anesthesia on Postoperative Pain
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Wear noise-cancelling earphones
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring noise blocking, Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
group 1
group 2
Arm Description
Intraoperative intervention with noise-canceling earphones was performed to isolate the noise
After general anesthesia, the intervention of wearing noise-canceling earphones was not given
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Patient controlled analgesia pump analgesic consumption
Analgesic requirements was assessed by recording the volume of patient controlled analgesia pump
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
Full Information
NCT ID
NCT05540691
First Posted
September 6, 2022
Last Updated
March 28, 2023
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05540691
Brief Title
Effect of Noise Blocking During General Anesthesia on Postoperative Pain
Official Title
Effect of Noise Blocking During General Anesthesia on Postoperative Pain in Patients Undergoing Laparoscopic Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 8, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Chongqing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
noise blocking, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were randomly divided into intervention group（noise blocking） and control group（No noise blocking）
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Description
Intraoperative intervention with noise-canceling earphones was performed to isolate the noise
Arm Title
group 2
Arm Type
No Intervention
Arm Description
After general anesthesia, the intervention of wearing noise-canceling earphones was not given
Intervention Type
Device
Intervention Name(s)
Wear noise-cancelling earphones
Intervention Description
Intervention of wearing noise-canceling earphones after general anesthesia
Primary Outcome Measure Information:
Title
Maximum pain score (NRS score) at 0-24 hours postoperatively
Description
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 24 hours postoperatively
Title
Pain score (NRS score) at 0-6 hours postoperatively
Description
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 6 hours postoperatively
Title
Pain score (NRS score) at 6-12 hours postoperatively
Description
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Time Frame
From 6 hours postoperatively to 12 hours postoperatively
Title
Pain score (NRS score) at 12-24 hours postoperatively
Description
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Time Frame
From 12 hours postoperatively to 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Patient controlled analgesia pump analgesic consumption
Description
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
Title
Postoperative hyperalgesia after surgery
Description
Postoperative hyperalgesia was measured by the ratio of pressure pain threshold at time when discharged from postanesthesia care unit compare to before surgery
Time Frame
from the 30 minutes before the surgery until to 30 minutes after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huang He, doctor
Organizational Affiliation
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Effect of Noise Blocking During General Anesthesia on Postoperative Pain
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