The Effect of Circadian Rhytm on Postoperative Pain Undergoing Pediatric Surgery

• Conditions: Postoperative Pain; Circadian Rhythm
• Interventions: Other: Group 1, Group 2, Group 3, Group 4

• Registration Number: NCT05379192
• Lead Sponsor: Faruk Cicekci

Brief Summary

These circadian rhythms are self-sustained, endogenous oscillations generated by circadian clocks that persist with a period of around 24 -h under constant conditions. Multiple clinical and foundational science studies report that circadian rhythm disruption can directly alter pain thresholds. Altered circadian pain rhythms manifest inconsistently in various disease states. circadian differences exist in tolerability of administration as well as in effectiveness of analgesia during surgical, obstetric, and dental procedures, with the majority of studies demonstrating highest pain sensitivity during the overnight or early morning hours. Although the relationship between pain states and circadian rhythm has been studied in various surgical procedures and chronic pain syndromes, there is little literature examining the relationship between postoperative pain and circadian rhythm in pediatric surgical procedures. Therefore, it was aimed to evaluate the relationship between postoperative pain and circadian rhythm after pediatric acute appendicitis surgery.

Detailed Description

This study will be conducted with the data to be obtained from the Anesthesiology Surgery Form and Pediatric Surgery Service Forms in 200 patients aged 6-18 years, after the approval of the Faculty Local Ethics Committee in the Department of Anesthesiology, Faculty of Medicine, Selcuk University. According to the time the patients were taken into the operation, Group 1; 01:01-07:00, Group 2; 07:01-13:00, Group 3; 13:01-20:00 and Group 4; 20:01-01:00, It will be divided into four groups between. The files of the patients will be examined and demographic data such as age (year), body weight (kg), height (cm), gender, ASA scores (I-III), anesthesia and surgery time, anesthesia and surgery time will be recorded. Intraoperative vital signs; systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR) oxygen saturation (SpO2) Endtidal CO2 and temperature before operation (control) and 5, 10, 15, 20, 25 and 30 minutes (min) and at the end of the process (end) data will also be saved. Perioperative side effects such as nausea-vomiting, hypotension, bradycardia, tremor, respiratory distress, sore throat, headache, and dizziness symptoms will be noted if they occur. The routinely applied analgesic protocol and vital signs in the postoperative pediatric surgery service, the total amount of analgesic administered, the time to first analgesia requirement and VAS scores at 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded. There will be no interference with the routinely applied analgesic protocol.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-04-29
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-17
• Last Update Submitted: 2022-05-17
• Study First Posted: 2022-05-18
• Last Update Posted: 2022-05-18
• Primary Completion: 2022-08-15
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical condition I-II,
• Undergoing acute appendicitis,
• Patients aged 6-18 years

Exclusion Criteria

• ASA ≥ III,
• Uncontrolled chronic, metabolic disease,
• Opioid or analgesic use in the last 10 days,
• Acute peritonitis or sepsis
• History of abnormal operation or recovery from anesthesia,
• Patients with parents who are unwilling to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Group 1, Group 2, Group 3, Group 4	Patients who were operated between 07:01-13:00. Sociodemographic and clinical data of the patients who will be operated between 07:00 AM- 01:00 PM will be recorded. The total amount of antiemetic, the time of first antiemetic use, and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded.
Group 4	Group 1, Group 2, Group 3, Group 4	Sociodemographic and clinical data of the patients who will be operated between 08:00 PM -01:00 AM will be recorded. The total amount of antiemetic,the time of first antiemetic use, and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded.
Group 3	Group 1, Group 2, Group 3, Group 4	Sociodemographic and clinical data of the patients who will be operated between 01:00 - 08:00 PM will be recorded. The total amount of antiemetic, the time of first antiemetic use and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded.
Group 1	Group 1, Group 2, Group 3, Group 4	Sociodemographic and clinical data of the patients who will be operated between 01:01-07:00 AM will be recorded. The total amount of antiemetic, the time of first antiemetic use, and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded.

Primary Outcome Measures

Name	Time	Method
The postoperative VAS pain scores	24th hours , postoperatively	The VAS scores at 24th will be recorded.

Secondary Outcome Measures

Name	Time	Method
The total amount of analgesic	24 hours, postoperatively	The total amount of analgesic will be recorded postoperativly .
the time to first analgesia requirement	24 hours, postoperatively	the time to first analgesia requirement will be recorded postoperativly .

Trial Locations

Locations (1)

Selcuk University, School of Medicine; 🇹🇷 Konya, Turkey