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NCT Number: NCT06316440

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chongqing, Chongqing Municipality, 400010, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wear noise-cancelling earphones

Device

Intervention of wearing noise-canceling earphones after general anesthesia

Primary outcomes

  1. The incidence of moderate to severe postoperative pain

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

    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)

Secondary outcomes

  1. Patient controlled analgesia pump analgesic consumption

    Time frame: 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. Patient controlled analgesia pump analgesic consumption

    Time frame: From the time when the surgery was completed until to 48 hours after surgery

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

  3. The incidence of additional analgesic requirements

    Time frame: From the time when the surgery was completed until to 48 hours after surgery

    the percentage of patients who received additional analgesic out of the total number of patients in the group

  4. Maximum pain score (NRS score) at 0-48 hours postoperatively

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

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

  5. The incidence of moderate to severe postoperative pain

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

    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)

  6. Accumulative postoperative pain NRS

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

    Accumulative NRS score (Pain was assessed using NRS scale of 0-10, with 0 being no pain and 10 being most painful) at 6, 12, 24 and 48 hours after surgery

Other outcomes

  1. Pain score (NRS score) at 0-6 hours postoperatively

    Time frame: 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

  2. Pain score (NRS score) at 6-12 hours postoperatively

    Time frame: From ending of the surgery 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

  3. Pain score (NRS score) at 12-24 hours postoperatively

    Time frame: 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

  4. Pain score (NRS score) at 24-48 hours postoperatively

    Time frame: From 24 hours postoperatively to 48 hours postoperatively

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

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Collaborators

  • ChongGang General Hospital
  • Chongqing Hechuan District People's Hospital
  • Chongqing Qijiang District People's Hospital
  • Shapingba People's Hospital of Chongqing University
  • The 3rd. Affiliated Hospital of Chongqing Medical University
  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study title

Effect of Noise Isolation During General Anesthesia on the Incidence of Moderate to Severe Postoperative Pain in Patients Undergoing Major Abdominal Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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