Postoperative PainNCT05681091
Effect of Perioperative Hypothermia on Postoperative Pain
An observational study of Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2022to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: the patients' age is during 18-70 years old
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Guangyou Duan, M.D, 18323376014, duangy@hospital.cqmu.edu.cn
shuai you, 15823826973, 197372465@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From ending of the surgery to 24 hours after anesthetic resuscitation
Secondary outcomes (2)
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).
Measured: 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.
Measured: From beginning of the surgery to the time when discharge from postanesthesia care unit with a mean of 30 minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start17 Oct 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang He, MD, Study director, Department of Anesthesiology, The Second Affiliated Hospital, Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681091
- Sponsor's protocol ID
- Body temperature and pain
- Status last verified
- Feb 2023
- First submitted
- 27 Dec 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Hypothermia on Postoperative Pain and Pain Sensitization With Laparoscopic Surgery: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05681091
- Acronym / sponsor ID
- Body temperature and pain
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the patients' age is during 18-70 years old
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients' pain score after surgery
Time frame: 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).
2 secondary outcomes
Patients' pain score during postanesthesia care unit
Time frame: 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
Time frame: From beginning of the surgery to the time when discharge from postanesthesia care unit with a mean of 30 minutes after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huang He, MD study director
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang He, MD (13708385557 ext. +86, huanghe@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' pain score after surgery (time frame: From ending of the surgery to 24 hours after anesthetic resuscitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.