SurgeryNCT05590767

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

An observational study of Surgery and Shoulder Impingement, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 85 years
Conditions the study is for: Surgery, Shoulder Impingement
What is being tested?: Patients scheduled to undergo shoulder rotators repair surgery
Type of treatment: Surgery or procedure
How many people: 40 participants
Where: 1 siteTaiwan
Study dates: 27 Oct 2022to 31 Aug 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients scheduled to undergo shoulder rotators repair surgery

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Department of Anesthesiology, Tri-Service General Hospital
Taipei, 114

Other trials in Taiwan

About this study

Official title: Department of Anesthesiology, Tri-Service General Hospital and National Defense Medical Center , Taipei, Taiwan

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?

Read the 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 = 0.62; P = 0.002). 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?

Conditions: Surgery, Shoulder Impingement
Being tested: Patients scheduled to undergo shoulder rotators repair surgery
Medical subject headings: Shoulder Impingement Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05590767
Study group	Role	What they receive
shoulder rotators repair		Patients scheduled to undergo shoulder rotators repair surgery Receives: Procedure: Patients scheduled to undergo shoulder rotators repair surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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 .
Measured: After induction of anesthesia and before surgical incision

Secondary outcomes (1)

Difference Between Intraoperative Pupillary Pain Index (PPI) and Postoperative Numerical Pain Scale (NRS)
1. PPI: 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.
2. NRS: the nursing staff in the post-anesthesia care unit asked the patient to rate their pain at the surgical site using the NRS, with a range of 0(no pain)-10(most severe pain).
Measured: From emergency of anesthesia to early Post-anesthesia period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 202231 Aug 2023

First posted21 Oct 2022
Study start27 Oct 2022
Primary completion17 Aug 2023
Study completion31 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05590767
Sponsor's protocol ID: C202205095
Status last verified: May 2024
First submitted: 18 Oct 2022
Last updated: 3 May 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Department of Anesthesiology, Tri-Service General Hospital and National Defense Medical Center , Taipei, Taiwan
ClinicalTrials.gov ID: NCT05590767
Acronym / sponsor ID: C202205095
Conditions: Surgery, Shoulder Impingement
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Tri-Service General Hospital (TSGH)University, hospital or other
Study start: 27 Oct 2022 (actual)
Primary completion: 17 Aug 2023 (actual)
Study completion: 31 Aug 2023 (actual)
First posted: 21 Oct 2022 (actual)
Results: Posted 3 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
shoulder rotators repair	–	Procedure: Patients scheduled to undergo shoulder rotators repair surgeryPatients scheduled to undergo shoulder rotators repair surgery

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients scheduled to undergo shoulder rotators repair surgery

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patients scheduled to undergo shoulder rotators repair surgeryPatients scheduled to undergo shoulder rotators repair surgery, and received combined general anesthesia and interscalene block	Procedure or surgery	shoulder rotators repair

Primary outcome

Pupillary Pain Index (PPI )
Time frame: After induction of anesthesia and before surgical incision
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 .

1 secondary outcome

Difference Between Intraoperative Pupillary Pain Index (PPI) and Postoperative Numerical Pain Scale (NRS)
Time frame: From emergency of anesthesia to early Post-anesthesia period

Results and safety

Results posted to the registry on 3 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Shoulder Rotators Repair	40	37

Primary outcome: Pupillary Pain Index (PPI )

Time frame: After induction of anesthesia and before surgical incision. Mean (Standard Deviation). Unit: score on a scale

Measure	Shoulder Rotators Repair n = 34
ISB side	1.8 (0.2)
Control side	6.6 (0.3)

Population analysed: 40 patients scheduled for rotator cuff surgery were recruited for this study. Of these, three did not follow the study protocol: one had canceled surgery, one did not undergo ISB, and in one case, sevoflurane was not used as the main anesthetic. For the remaining 37 patients, Three patients did not report a loss of subjective cold/pinprick sensation in the C5 and C6 dermatomes, indicating an unsuccessful block. Therefore, 34 patients were included in the final analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Shoulder Rotators Repair	0 of 34 (0%)	0 of 34 (0%)	0 of 34

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yeh Chun-chang, M.D. principal investigator

Department of Anesthesiology, Tri-Service General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery and Shoulder Impingement, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pupillary Pain Index (PPI ) (time frame: After induction of anesthesia and before surgical incision). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05590767.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.