Effect of Noise Blocking During General Anesthesia on Postoperative Pain

Sponsor
The Second Affiliated Hospital of Chongqing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05540691
Collaborator
(none)
90
1
2
3.6
24.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Wear noise-cancelling earphones
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients were randomly divided into intervention group(noise blocking) and control group(No noise blocking)Patients were randomly divided into intervention group(noise blocking) and control group(No noise blocking)
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Noise Blocking During General Anesthesia on Postoperative Pain in Patients Undergoing Laparoscopic Abdominal Surgery
Anticipated Study Start Date :
Sep 12, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Maximum pain score (NRS score) at 0-24 hours postoperatively [From ending of the surgery to 24 hours postoperatively]

    NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

  2. Pain score (NRS score) at 0-6 hours postoperatively [From ending of the surgery to 6 hours postoperatively]

    NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

  3. Pain score (NRS score) at 6-12 hours postoperatively [From 6 hours postoperatively to 12 hours postoperatively]

    NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

  4. Pain score (NRS score) at 12-24 hours postoperatively [From 12 hours postoperatively to 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

  1. Patient controlled analgesia pump analgesic consumption [From the time when the surgery was completed until to 24 hours after surgery]

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

  2. Postoperative hyperalgesia after surgery [from the 30 minutes before the surgery until to 30 minutes 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University Chongqing Chongqing China 400010

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT05540691
Other Study ID Numbers:
  • Noise blocking and pain
First Posted:
Sep 15, 2022
Last Update Posted:
Sep 15, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Second Affiliated Hospital of Chongqing Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 15, 2022