Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids

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 Overview

• Status: Completed
• Conditions: Postoperative Hyperalgesia
• Intervention / Treatment: Drug: Remifentanil

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Morning group; Surgery performed during 08:00 to 12:00	Drug: Remifentanil; Remifentanil was used for maintenance of anesthesia.
Afternoon group; Surgery performed during 14:00 to 18:00	Drug: Remifentanil; Remifentanil was used for maintenance of anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Somatosensory Disorders; Hyperalgesia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: Postoperative hyperalgesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The individual participant data for this study is available from the sponsor on reasonable request through email.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No