N/A
N=40
Pupillary Pain Index to Evaluate Interscalene Block and Postoperative Pain in Patients Underwent Shoulder Surgery
Surgery · Shoulder Impingement
Bottom Line
View on ClinicalTrials.gov: NCT05590767 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Pupillary Pain Index (PPI ) — 1.8; 6.6 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Patients scheduled to undergo shoulder rotators repair surgery (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tri-Service General Hospital
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pupillary Pain Index (PPI ) |
1.8; 6.6 | — |
| SECONDARY Difference Between Intraoperative Pupillary Pain Index (PPI) and Postoperative Numerical Pain Scale (NRS) |
1.5; 1.7 | — |
Summary
When an individual encounters nociceptive pain stimuli, the pupil dilates in a unique manner known as Pupil reflex dilation (PRD).The 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?
Eligibility Criteria
Inclusion Criteria
- Patients who received general anesthesia combined with ipsilateral interscalene block
- Patients listed as a Class I/II physical condition of the American Society ofAnesthesiologists
Exclusion Criteria
- Patients younger than 20 years of age
- The presence of ophthalmologic (recent eye surgery or cataracts) or neurologic diseases (diabetic neuropathy,or postherpetic neuralgia) that could interfere with Pupillometer
Data sourced from ClinicalTrials.gov (NCT05590767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.