NCT05681091

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

December 27, 2022

Last Update Submit

February 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • 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

  • 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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the patients' age is during 18-70 years old

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Huang He, MD

    Department of Anesthesiology, The Second Affiliated Hospital, Chongqing

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2022

First Posted

January 12, 2023

Study Start

October 17, 2022

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations