Effect of Perioperative Hypothermia on Postoperative Pain

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Recruiting
      • Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

the patients' age is during 18-70 years old

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Body Temperature Changes; Pain, Postoperative; Hypothermia
• Other Study ID Numbers: Body temperature and pain

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No