Postoperative HyperalgesiaNCT05234697
Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids
An observational study of Postoperative Hyperalgesia, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
To explore the effect of daytime variation on postoperative hyperalgesia induced by opioids. Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia maintenance were respectively included. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Hyperalgesia
- What is being tested?
- Remifentanil
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2022to 20 May 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia maintenance were included.
Who may be able to join
- American Society of Anesthesiologists classification I-II
- Abdominal endoscopy surgery
- Estimated surgery duration 1-2h
- Right handedness
- Voluntarily receive postoperative intravenous controlled analgesia
Who cannot join
- Heavy smoking or alcohol dependence
- Puerpera or lactation women
- History of chronic pain
- Analgesic use within one month before surgery
- Allergy to opioids
- Can not follow with the study procedure
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
To explore the effect of daytime variation on postoperative hyperalgesia induced by opioids. Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia maintenance were respectively included. Postoperative hyperalgesia at PACU and 24 hours after surgery were assessed through mechanical pain measurement. Comparative analysis of postoperative hyperalgesia levels, pain and analgesic requirements between morning group and afternoon group were performed.
- Conditions
- Postoperative Hyperalgesia
- Being tested
- Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Remifentanil was used for maintenance of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Morning group | Surgery performed during 08:00 to 12:00 Receives: Drug: Remifentanil | |
| Afternoon group | Surgery performed during 14:00 to 18:00 Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hyperalgesia when discharged from postanesthesia care unit
The ratio of pressure pain threshold when discharged from PACU compare to before surgery
Measured: from the 30 minutes before the surgery until to the time when discharged from postanesthesia care unit, assessed up to about 2 hours
Secondary outcomes (5)
Postoperative hyperalgesia at 24 hours after surgery
The ratio of pressure pain threshold at 24 hours after surgery compare to before surgery
Measured: from the 30 minutes before the surgery until to 24 hours after surgery
Postoperative pain intensity
Pain intensity was assessed by numerical rating scale (0-10, 0 represents painless; 10 represents intolerable pain)
Measured: from the time when the surgery was completed until to 24 hours after surgery
Postoperative analgesic requirements
Analgesic requirements was assessed by recording the volume of patient controlled analgesia pump
Measured: from the time when the surgery was completed until to 24 hours after surgery
Plasma concentration of remifentanil and sufentanil
Determined by Elisa test
Measured: from 30 minutes before the surgery until to the time after stop infusion of remifentanil, assessed up to about 2 hours
Activity of plasma nonspecific esterase
Determined by laboratory detection
Measured: from 30 minutes before the surgery until to the time after stop infusion of remifentanil, , assessed up to about 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start12 Jan 2022
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative HyperalgesiaStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234697
- Sponsor's protocol ID
- Postoperative hyperalgesia
- Status last verified
- Dec 2022
- First submitted
- 12 Jan 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data for this study is available from the sponsor on reasonable request through email.
Publications
Shu B, Liu H, Zheng X, He J, Wu Y, Chen J, Chen Y, Tian H, Ju D, Huang H, Duan G. Opioid infusions at different times of the day produce varying degrees of opioid-induced hyperalgesia. Br J Anaesth. 2023 Dec;131(6):1072-1081. doi: 10.1016/j.bja.2023.08.039. Epub 2023 Oct 9.
PubMed 37821342
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids
- ClinicalTrials.gov ID
- NCT05234697
- Acronym / sponsor ID
- Postoperative hyperalgesia
- Conditions
- Postoperative Hyperalgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 10 Feb 2022 (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.
To explore the effect of daytime variation on postoperative hyperalgesia induced by opioids. Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia maintenance were respectively included. Postoperative hyperalgesia at PACU and 24 hours after surgery were assessed through mechanical pain measurement. Comparative analysis of postoperative hyperalgesia levels, pain and analgesic requirements between morning group and afternoon group were performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning group | – | Drug: RemifentanilSurgery performed during 08:00 to 12:00 |
| Afternoon group | – | Drug: RemifentanilSurgery performed during 14:00 to 18:00 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia maintenance were included.
Key inclusion criteria (5 listed)
- American Society of Anesthesiologists classification I-II
- Abdominal endoscopy surgery
- Estimated surgery duration 1-2h
- Right handedness
- Voluntarily receive postoperative intravenous controlled analgesia
Key exclusion criteria (6 listed)
- Heavy smoking or alcohol dependence
- Puerpera or lactation women
- History of chronic pain
- Analgesic use within one month before surgery
- Allergy to opioids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilRemifentanil was used for maintenance of anesthesia. | Drug | Afternoon group, Morning group |
Primary outcome
Postoperative hyperalgesia when discharged from postanesthesia care unit
Time frame: from the 30 minutes before the surgery until to the time when discharged from postanesthesia care unit, assessed up to about 2 hours
The ratio of pressure pain threshold when discharged from PACU compare to before surgery
5 secondary outcomes
Postoperative hyperalgesia at 24 hours after surgery
Time frame: from the 30 minutes before the surgery until to 24 hours after surgery
Postoperative pain intensity
Time frame: from the time when the surgery was completed until to 24 hours after surgery
Postoperative analgesic requirements
Time frame: from the time when the surgery was completed until to 24 hours after surgery
Plasma concentration of remifentanil and sufentanil
Time frame: from 30 minutes before the surgery until to the time after stop infusion of remifentanil, assessed up to about 2 hours
Activity of plasma nonspecific esterase
Time frame: from 30 minutes before the surgery until to the time after stop infusion of remifentanil, , assessed up to about 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Derived from this study: PubMed 37821342Shu B, Liu H, Zheng X, He J, Wu Y, Chen J, Chen Y, Tian H, Ju D, Huang H, Duan G. Opioid infusions at different times of the day produce varying degrees of opioid-induced hyperalgesia. Br J Anaesth. 2023 Dec;131(6):1072-1081. doi: 10.1016/j.bja.2023.08.039. Epub 2023 Oct 9.
- Individual participant dataSharing planned: Yes. The individual participant data for this study is available from the sponsor on reasonable request through email.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hyperalgesia, 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 28 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative hyperalgesia when discharged from postanesthesia care unit (time frame: from the 30 minutes before the surgery until to the time when discharged from postanesthesia care unit, assessed up to about 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05234697, which also lists 1 linked publication.
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 28 Dec 2022.