Effect of Perioperative Hypothermia on Postoperative Pain

Sponsor

The Second Affiliated Hospital of Chongqing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05681091

Collaborator

(none)

240

Enrollment

Location

9.4

Anticipated Duration (Months)

25.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain

Study Design

Study Type:

Observational

Anticipated Enrollment :

240 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 17, 2022

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Outcome Measures

Primary Outcome Measures

Patients' pain score after surgery [From ending of the surgery to 24 hours after anesthetic resuscitation]
The patients' pain score was tested with Numerical analogue scale of pain (0-10, 0 represents pain free, and 10 represents unbearable pain).

Secondary Outcome Measures

Patients' pain score during postanesthesia care unit [From ending of the surgery to the time when discharge from postanesthesia care unit with a mean of 30 minutes 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).
Pressure pain threshold [From beginning of the surgery to the time when discharge from postanesthesia care unit with a mean of 30 minutes after surgery]
the patients' pain threshold was tested by tenderness meter.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 18-70 years old
ASA 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing	China	400010

Sponsors and Collaborators

The Second Affiliated Hospital of Chongqing Medical University

Investigators

Study Director: Huang He, MD, Department of Anesthesiology, The Second Affiliated Hospital, Chongqing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Second Affiliated Hospital of Chongqing Medical University

ClinicalTrials.gov Identifier:

NCT05681091

Other Study ID Numbers:

Body temperature and pain

First Posted:

Jan 12, 2023

Last Update Posted:

Jan 12, 2023

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Hypothermia

Study Results

No Results Posted as of Jan 12, 2023