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Completed

NCT Number: NCT05540691

Effect of Noise Blocking During General Anesthesia on Postoperative Pain

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.

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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

  • 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

Treatment and study plan

Wear noise-cancelling earphones

Device

Intervention of wearing noise-canceling earphones after general anesthesia

Primary outcomes

  1. Maximum pain score (NRS score) at 0-24 hours postoperatively

    Time frame: 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

    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

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

    Time frame: 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

    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

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. Postoperative hyperalgesia after surgery

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 15, 2022
Registry last updated
Mar 29, 2023

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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