Viewing Study NCT05590767



Ignite Creation Date: 2024-05-06 @ 6:15 PM
Last Modification Date: 2024-10-26 @ 2:44 PM
Study NCT ID: NCT05590767
Status: COMPLETED
Last Update Posted: 2024-05-03
First Post: 2022-10-18

Brief Title: Pupillary Pain Index to Evaluate Interscalene Block and Postoperative Pain in Patients Underwent Shoulder Surgery
Sponsor: Tri-Service General Hospital
Organization: Tri-Service General Hospital

Study Overview

Official Title: Department of Anesthesiology Tri-Service General Hospital and National Defense Medical Center Taipei Taiwan
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: When an individual encounters nociceptive pain stimuli the pupil dilates in a unique manner known as Pupil reflex dilation PRDThe degree of pupillary reflex dilatation can be further quantified into an objective parameter termed the Pupillary pain index PPI as a monitoring tool for the balance between nociception and antinociception in surgical patients The motivation for this study is to investigate the feasibility of using pupillometry to assess acute pain after shoulder surgery The purpose of the study is as follows 1 Can PDR in patients undergoing general anesthesia be used to assess the analgesic effect of interscalene block 2 Does PPI at the end of surgical anesthesia in such patients correlate with the first numerical pain scale NRS during the recovery room
Detailed Description: When an individual encounters nociceptive pain stimuli the pupil dilates in a unique way called pupillary reflex dilation PRD which can be observed both when the individual is awake or under anesthesia The degree of pupillary reflex dilatation can be further quantified into an objective parameter called the Pupillary pain index PPI which serves as a monitoring tool for the balance between nociception and antinociception in surgical patients Larson studied 32 female breast surgery patients who received general anesthesia combined with thoracic paravertebral nerve block on the affected side The results showed that the affected side of the nerve block had significantly lower pupillary reflex dilation than those without nerve block on the healthy side of the breast The authors believed that this study confirmed the value of pupillary reflex dilation in monitoring the success rate of unilateral thoracic paravertebral nerve block during general anesthesia In a prospective observational study of 26 patients undergoing neurosurgery under general anesthesia Pupillary pain index at the end of surgical anesthesia and Numerical Rating Scale NRS during the recovery room were recorded separately The results showed a significant correlation between the two parameters rS 062 P 0002 The authors concluded that the application of the measurement of pupillary reflex dilation may be useful in predicting and preventing acute postoperative pain Shoulder rotator muscle repair is a common surgery in our hospital Patients must receive general anesthesia sometimes combined with scalene interscalene block ISB to improve postoperative acute pain help to perform passive shoulder rehabilitation exercises and prevent shoulder joint adhesions Based on the above literature review the motivation for this study was to investigate the feasibility of using pupillometry to assess acute pain after shoulder surgery The objectives of the research project are as follows 1 Can pupillary reflex dilation in patients undergoing general anesthesia be used to assess the analgesic effect of scalene nerve block 2 Is the pupillary pain index PPI at the end of surgical anesthesia correlated with the first numerical pain scale NRS during the recovery room in such patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None