Trial Outcomes & Findings for Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI) (NCT NCT01633320)

Results Overview

The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.

Recruitment status

COMPLETED

Target enrollment

200 participants

Primary outcome timeframe

At arrival in post-operative care unit (PACU) or 10 min after extubation

Results posted on

2012-12-18

Participant Flow

Study performed between June and July 2012 at Édouard Herriot university hospital,Lyon, France. 200 American Society of Anesthesiologists physical status I-II patients undergoing general anesthesia were included. The procedures performed were ear, nose and throat surgery or endoscopy and plastic surgery.

No patient were excluded from the trial before assignment to groups

Participant milestones

Participant milestones
Measure	NRS<=3 (no or Mild Pain) Patients with numerical rating pain scale \<=3 at arrival in PACU	NRS>3 (Moderate to Severe Pain) Patients with numerical rating scale pain score \>3 at arrival in PACU
Overall Study STARTED	132	68
Overall Study COMPLETED	132	68
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NRS<=3 n=132 Participants Patients with numerical rating scale \<=3 at arrival in PACU	NRS>3 n=68 Participants Patients with numerical rating scale pain score \>3 at arrival in PACU	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	118 Participants n=5 Participants	62 Participants n=7 Participants	180 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Age Continuous	41 years STANDARD_DEVIATION 18 • n=5 Participants	44 years STANDARD_DEVIATION 15 • n=7 Participants	43 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	26 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	42 Participants n=7 Participants	112 Participants n=5 Participants
Region of Enrollment France	132 participants n=5 Participants	68 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: At arrival in post-operative care unit (PACU) or 10 min after extubation

The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.

Outcome measures

Outcome measures
Measure	NRS<=3 n=132 Participants Patients with numerical rating scale \<=3 at arrival in PACU	NRS>3 n=68 Participants Patients with numerical rating scale pain score \>3 at arrival in PACU
Analgesia/Nociception Index (ANI)	73 units on a scale Standard Deviation 17	49 units on a scale Standard Deviation 14

PRIMARY outcome

Timeframe: At arrival in PACU or 10 min after extubation

Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS\<3 corresponds to no or mild pain NRS\>=3 corresponds to moderate to severe pain NRS\>=7 corresponds to severe pain

Outcome measures

Outcome measures
Measure	NRS<=3 n=132 Participants Patients with numerical rating scale \<=3 at arrival in PACU	NRS>3 n=68 Participants Patients with numerical rating scale pain score \>3 at arrival in PACU
Pain Scores on a 0-10 Numeric Rating Scale (NRS)	1 units on a scale Standard Deviation 1	5 units on a scale Standard Deviation 1

Adverse Events

NRS<=3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NRS>3

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 Emmanuel Boselli

Edouard Herriot hôspital Anaesthesia and intensive care

Phone: +334711689

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place