Trial Outcomes & Findings for Pupillary Pain Index to Evaluate Interscalene Block and Postoperative Pain in Patients Underwent Shoulder Surgery (NCT NCT05590767)

Results Overview

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 .

Recruitment status

COMPLETED

Target enrollment

40 participants

Primary outcome timeframe

After induction of anesthesia and before surgical incision

Results posted on

2024-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	Shoulder Rotators Repair Patients scheduled to undergo shoulder rotators repair surgery Patients scheduled to undergo shoulder rotators repair surgery: Patients scheduled to undergo shoulder rotators repair surgery, and received combined general anesthesia and interscalene block
Overall Study STARTED	40
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Shoulder Rotators Repair Patients scheduled to undergo shoulder rotators repair surgery Patients scheduled to undergo shoulder rotators repair surgery: Patients scheduled to undergo shoulder rotators repair surgery, and received combined general anesthesia and interscalene block
Overall Study Protocol Violation	1
Overall Study surgery canceled	1
Overall Study interscalene brachial block not performed	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Shoulder Rotators Repair n=34 Participants Patients scheduled to undergo shoulder rotators repair surgery Patients scheduled to undergo shoulder rotators repair surgery: Patients scheduled to undergo shoulder rotators repair surgery, and received combined general anesthesia and interscalene block
Age, Continuous	62 years old STANDARD_DEVIATION 11 • n=34 Participants
Sex: Female, Male Female	21 Participants n=34 Participants
Sex: Female, Male Male	13 Participants n=34 Participants
Region of Enrollment Taiwan	34 participants n=34 Participants
Body Mass Index (BMI)	24.1 kg/m^2 STANDARD_DEVIATION 2.7 • n=34 Participants

PRIMARY outcome

Timeframe: After induction of anesthesia and before surgical incision

Population: 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.

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 .

Outcome measures

Outcome measures
Measure	Shoulder Rotators Repair n=34 Participants Patients scheduled to undergo shoulder rotators repair surgery Patients scheduled to undergo shoulder rotators repair surgery: Patients scheduled to undergo shoulder rotators repair surgery, and received combined general anesthesia and interscalene block
Pupillary Pain Index (PPI ) ISB side	1.8 score on a scale Standard Deviation 0.2
Pupillary Pain Index (PPI ) Control side	6.6 score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: From emergency of anesthesia to early Post-anesthesia period

Population: 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. 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).

Outcome measures

Outcome measures
Measure	Shoulder Rotators Repair n=34 Participants Patients scheduled to undergo shoulder rotators repair surgery Patients scheduled to undergo shoulder rotators repair surgery: Patients scheduled to undergo shoulder rotators repair surgery, and received combined general anesthesia and interscalene block
Difference Between Intraoperative Pupillary Pain Index (PPI) and Postoperative Numerical Pain Scale (NRS) intraoperative PPI	1.5 score on a scale Standard Deviation 0.2
Difference Between Intraoperative Pupillary Pain Index (PPI) and Postoperative Numerical Pain Scale (NRS) postoperative NRS	1.7 score on a scale Standard Deviation 1.3

Adverse Events

Shoulder Rotators Repair

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lu Yi-Hsiung

Tri-Service General Hospital, National Defense Medical Center

Phone: +886933429559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place