Postoperative Pain
Conditions
Keywords
Analgesia/Nociception index
Brief summary
The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia.
Detailed description
Evaluation of the relationship between ANI and numerical rating pain scale (NRS) by linear regression. Assessment of the performance of ANI to detect NRS\>3 and NRS\>=7 by building ROC curves.
Interventions
None listed
Sponsors
Hôpital Edouard Herriot
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* adult * surgical or endoscopic procedures performed on general anesthesia
Exclusion criteria
* age \<18 yrs or \>75 yrs * arrythmia * administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes * psychiatric diseases * autonomic nervous system (ANS) disorders * inability to understand the verbal rating pain scale.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesia/Nociception Index (ANI) | 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. |
| Pain Scores on a 0-10 Numeric Rating Scale (NRS) | 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 |
Countries
France
Participant flow
Recruitment details
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.
Pre-assignment details
No patient were excluded from the trial before assignment to groups
Participants by arm
| Arm | Count |
|---|---|
| NRS<=3 Patients with numerical rating scale \<=3 at arrival in PACU | 132 |
| NRS>3 Patients with numerical rating scale pain score \>3 at arrival in PACU | 68 |
| Total | 200 |
Baseline characteristics
| Characteristic | NRS>3 | NRS<=3 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 14 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 118 Participants | 180 Participants |
| Age Continuous | 44 years STANDARD_DEVIATION 15 | 41 years STANDARD_DEVIATION 18 | 43 years STANDARD_DEVIATION 15 |
| Region of Enrollment France | 68 participants | 132 participants | 200 participants |
| Sex: Female, Male Female | 26 Participants | 62 Participants | 88 Participants |
| Sex: Female, Male Male | 42 Participants | 70 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 132 | 0 / 68 |
| serious Total, serious adverse events | 0 / 132 | 0 / 68 |
Outcome results
Primary
Analgesia/Nociception Index (ANI)
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.
Time frame: At arrival in post-operative care unit (PACU) or 10 min after extubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NRS<=3 | Analgesia/Nociception Index (ANI) | 73 units on a scale | Standard Deviation 17 |
| NRS>3 | Analgesia/Nociception Index (ANI) | 49 units on a scale | Standard Deviation 14 |
Primary
Pain Scores on a 0-10 Numeric Rating Scale (NRS)
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
Time frame: At arrival in PACU or 10 min after extubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NRS<=3 | Pain Scores on a 0-10 Numeric Rating Scale (NRS) | 1 units on a scale | Standard Deviation 1 |
| NRS>3 | Pain Scores on a 0-10 Numeric Rating Scale (NRS) | 5 units on a scale | Standard Deviation 1 |