Effect of Noise Blocking During General Anesthesia on Postoperative Pain

NCT05540691 | Completed DMC

• 1 other identifier: Noise blocking and pain
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

noise blocking; Postoperative Pain

Outcome Measures

Primary Outcomes (4)

• 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

  From ending of the surgery to 24 hours postoperatively

• 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

  From ending of the surgery to 6 hours postoperatively

• 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

  From 6 hours postoperatively to 12 hours postoperatively

• 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

  From 12 hours postoperatively to 24 hours postoperatively

Secondary Outcomes (2)

• Patient controlled analgesia pump analgesic consumption

  From the time when the surgery was completed until to 24 hours after surgery

• Postoperative hyperalgesia after surgery

  from the 30 minutes before the surgery until to 30 minutes after surgery

Study Arms (2)

group 1

EXPERIMENTAL

Intraoperative intervention with noise-canceling earphones was performed to isolate the noise

Device: Wear noise-cancelling earphones

group 2

NO INTERVENTION

After general anesthesia, the intervention of wearing noise-canceling earphones was not given

Interventions

Wear noise-cancelling earphones DEVICE

Intervention of wearing noise-canceling earphones after general anesthesia

group 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA Classification ⅰ-ⅲ
• Patients undergoing elective laparoscopic abdominal surgery under general anesthesia
• Voluntarily accept PCIA and signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400010, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Huang He, doctor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were randomly divided into intervention group（noise blocking） and control group（No noise blocking）

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 15, 2022
• Study Start: October 8, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 29, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Five years after the study

Locations

CN (1)