Effect of Perioperative Hypothermia on Postoperative Pain | NCT05681091

Studies
Effect of Perioperative Hypothermia on Postoperative Pain

NCT05681091

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Status

Unknown status

Last Update Posted

Feb 15, 2023Actual

Enrollment

240Estimated

Phase

Not provided

Conditions

Postoperative Pain

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2022Actual

Primary Completion Date

Jul 31, 2023Estimated

Completion Date

Jul 31, 2023Estimated

First Submitted Date

Dec 27, 2022

First Submission Date that Met QC Criteria

Dec 27, 2022

First Posted Date

Jan 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2023

Last Update Posted Date

Feb 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

the patients' age is during 18-70 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Huang He, MD	Contact	13708385557	+86	huanghe@cqmu.edu.cn

Overall Officials

Name	Affiliation	Role
Huang He, MD	Department of Anesthesiology, The Second Affiliated Hospital, Chongqing	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University	Recruiting	Chongqing	Chongqing Municipality	400010	China

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

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Browse Branches

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