Effect of Perioperative Hypothermia on Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

The Effect of Perioperative Hypothermia on Postoperative Pain and Pain Sensitization With Laparoscopic Surgery: a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05681091
• Other study ID #: Body temperature and pain
• Status: Recruiting
• Start date: October 17, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2023
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Huang He, MD
• Phone: 13708385557
• Email: huanghe[@]cqmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to observe the impact of perioperative body temperature on postoperative pain and pain sensitization for the patients with laparoscopic surgery. Based on this study the investigators aimed to explore the effect of perioperative hypothermia on postoperative pain.

Description:

This study aims to included surgery patients to observe the impact of perioperative body temperature on postoperative pain and pain sensitization for the patients with laparoscopic surgery. Body temperature and postoperative pain will be continuously assessed, and then association analysis will be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 years old

• American society of anesthesiologists I-III

• Patients who plan to laparoscopic surgery under general anesthesia

• Volunteer to participate in this study and sign informed consent.

Exclusion Criteria:

• the patient with chronic pain

• Patients with fever

• The patient is infected

• Severe vision, hearing, language impairment or other reasons unable to communicate with visitors

• Patients with known mental illness or lack of communication or cognitive impairment before operation;

• Long-term use of sedatives, antidepressants or alcoholism

• Artificial cooling and low temperature protection were taken during the operation

Related Conditions & MeSH terms

• Hypothermia
• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
China	Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' pain score after surgery	The patients' pain score was tested with Numerical analogue scale of pain (0-10, 0 represents pain free, and 10 represents unbearable pain).	From ending of the surgery to 24 hours after anesthetic resuscitation
Secondary	Patients' pain score during postanesthesia care unit	The patients' pain score was tested with Numerical analogue scale of pain (0-10, 0 represents pain free, and 10 represents unbearable pain).	From ending of the surgery to the time when discharge from postanesthesia care unit with a mean of 30 minutes after surgery
Secondary	Pressure pain threshold	the patients' pain threshold was tested by tenderness meter.	From beginning of the surgery to the time when discharge from postanesthesia care unit with a mean of 30 minutes after surgery