Pupillary Pain Index to Evaluate Interscalene Block and Postoperative Pain in Patients Underwent Shoulder Surgery

NCT05590767 | Completed Results

• 1 other identifier: C202205095
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Surgery; Shoulder Impingement

Outcome Measures

Primary Outcomes (1)

• Pupillary Pain Index (PPI )

  The primary outcome is the difference of the pupillary pain index (PPI ) between the ISB side and the control side The PPI mode applies a standardized, incremental transcutaneous electrical stimulation (100 Hz, 10-60mA, with 1-s intervals) that progressively increases in intensity until a pupil dilation of \>13% is observed. The degree of reflex dilation is quantified on a scale of 1 (very deep analgesia) to 9 (very light analgesia) and referred to as the PPI .

  After induction of anesthesia and before surgical incision

Secondary Outcomes (1)

• Difference Between Intraoperative Pupillary Pain Index (PPI) and Postoperative Numerical Pain Scale (NRS)

  From emergency of anesthesia to early Post-anesthesia period

Study Arms (1)

shoulder rotators repair

Patients scheduled to undergo shoulder rotators repair surgery

Procedure: Patients scheduled to undergo shoulder rotators repair surgery

Interventions

Patients scheduled to undergo shoulder rotators repair surgery PROCEDURE

Patients scheduled to undergo shoulder rotators repair surgery, and received combined general anesthesia and interscalene block

shoulder rotators repair

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo shoulder rotators repair surgery

You may qualify if:

• Patients who received general anesthesia combined with ipsilateral interscalene block
• Patients listed as a Class I/II physical condition of the American Society ofAnesthesiologists

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Department of Anesthesiology, Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Limitations and Caveats

the pupillometer's built-in PPI mode utilizes electrical stimulation up to 60 mA to simulate nociception. Therefore, the patient must be under sedation or anesthesia during the measurement to ensure comfort and safety.

Results Point of Contact

• Title: Dr. Lu Yi-Hsiung
• Organization: Tri-Service General Hospital, National Defense Medical Center

luyihsiung@gmail.com

+886933429559

Study Officials

• Yeh Chun-chang, M.D.

  Department of Anesthesiology, Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor, Department of Anesthesiology

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: October 27, 2022
• Primary Completion: August 17, 2023
• Study Completion: August 31, 2023
• Last Updated: May 3, 2024
• Results First Posted: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)