Pain, Stress
Conditions
Keywords
Analgesia, Sedation, Spinal, Stress, Surgical, Surgical Stress, Pain
Brief summary
The Surgical Pleth index (SPI) has been introduced as a non invasive tool to measure stress and pain during surgery. Preliminary studies were performed in patients under general anaesthesia with propofol and remifentanil. These trials showed a good correlation between SPI and aching procedures and a negative correlation between SPI and the remifentanil dosage. Hence, it was concluded that SPI may be a bedside tool to measure 'pain' during surgery. So far, no study investigated SPI during regional anaesthesia.
Detailed description
1. Spinal anaesthesia secures full pain relieve and muscle relaxation usually in the lower part of the body. Thus, SPI - a measure that reflects pain during surgery - may not exceed significantly compared to baseline. It may slightly increase only during administration of the block. 2. Increasing SPI values due to surgery under subarachnoid block may reflect intraoperative patient's stress mediated by activation of the autonomic nervous system, specifically sympathetic activation. 3. In consistence with previously published data no changes of SPI should occur due to standardized sedation with propofol.
Interventions
None listed
Sponsors
University Hospital Schleswig-Holstein
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* surgical procedures feasible under general or spinal anesthesia * duration between 30 and 90 min * ASA status I,II or III
Exclusion criteria
* contraindications against one of the anesthesia methods * age under 18 * emergencies * chronical pain history * lack of sinus rhythm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints | Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay | Surgical Pleth Index (SPI), derived from finger photoplethysmographic signal has a range from 0 showing the lowest stress level to 100 showing the maximum stress level. SPI was compared between the groups during six defined time points: baseline (BL)- day before surgery; induction (IND)-before induction of general anesthesia or before spinal punction respectively; intubation (INT) or spinal punction (SPA); skin incision (INC), surgical suture (SU) and 10 minutes after admission to the recovery room (PACU). Difference between the groups is calculated using ANOVA. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| General Anesthesia Patients undergoing short-term surgery (30-90 min) under general anesthesia | 21 |
| Spinal Patients undergoing short-term surgery (30-90 min) under spinal anesthesia | 20 |
| Spinal + Sedation Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation | 28 |
| Total | 69 |
Baseline characteristics
| Characteristic | General Anesthesia | Spinal | Spinal + Sedation | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 7 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 15 Participants | 21 Participants | 52 Participants |
| Age Continuous | 59 years STANDARD_DEVIATION 16 | 61 years STANDARD_DEVIATION 18 | 62 years STANDARD_DEVIATION 17 | 60 years STANDARD_DEVIATION 17 |
| Region of Enrollment Germany | 21 participants | 20 participants | 28 participants | 69 participants |
| Sex: Female, Male Female | 16 Participants | 17 Participants | 23 Participants | 56 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 20 | 0 / 28 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 | 0 / 28 |
Outcome results
Primary
Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints
Surgical Pleth Index (SPI), derived from finger photoplethysmographic signal has a range from 0 showing the lowest stress level to 100 showing the maximum stress level. SPI was compared between the groups during six defined time points: baseline (BL)- day before surgery; induction (IND)-before induction of general anesthesia or before spinal punction respectively; intubation (INT) or spinal punction (SPA); skin incision (INC), surgical suture (SU) and 10 minutes after admission to the recovery room (PACU). Difference between the groups is calculated using ANOVA.
Time frame: Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| General Anesthesia | Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints | Median SPI at skin incision | 46 SPI and delta SPI (to baseline) | Standard Error 4 |
| Spinal | Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints | Median SPI at skin incision | 67 SPI and delta SPI (to baseline) | Standard Error 3 |
| Spinal + Sedation | Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints | Median SPI at skin incision | 40 SPI and delta SPI (to baseline) | Standard Error 47 |