Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids

Postoperative Hyperalgesia Clinical Trial

Official title:

Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05234697
• Other study ID #: Postoperative hyperalgesia
• Status: Completed
• Start date: January 12, 2022
• Est. completion date: May 20, 2022

Study information

• Verified date: December 2022
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists classification I-II
• Abdominal endoscopy surgery
• Estimated surgery duration 1-2h
• Right handedness
• Voluntarily receive postoperative intravenous controlled analgesia

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hyperalgesia
• Postoperative Hyperalgesia

Intervention

Drug:
• Remifentanil
Remifentanil was used for maintenance of anesthesia.

Locations

Country	Name	City	State
China	Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative hyperalgesia when discharged from postanesthesia care unit	The ratio of pressure pain threshold when discharged from PACU compare to before surgery	from the 30 minutes before the surgery until to the time when discharged from postanesthesia care unit, assessed up to about 2 hours
Secondary	Postoperative hyperalgesia at 24 hours after surgery	The ratio of pressure pain threshold at 24 hours after surgery compare to before surgery	from the 30 minutes before the surgery until to 24 hours after surgery
Secondary	Postoperative pain intensity	Pain intensity was assessed by numerical rating scale (0-10, 0 represents painless; 10 represents intolerable pain)	from the time when the surgery was completed until to 24 hours after surgery
Secondary	Postoperative analgesic requirements	Analgesic requirements was assessed by recording the volume of patient controlled analgesia pump	from the time when the surgery was completed until to 24 hours after surgery
Secondary	Plasma concentration of remifentanil and sufentanil	Determined by Elisa test	from 30 minutes before the surgery until to the time after stop infusion of remifentanil, assessed up to about 2 hours
Secondary	Activity of plasma nonspecific esterase	Determined by laboratory detection	from 30 minutes before the surgery until to the time after stop infusion of remifentanil, , assessed up to about 2 hours