Nociceptive PainGORANCT06040307
Guiding Opioid Administration in Patients With Regional Anesthesia
A study testing SPI (Surgical Pleth Index) in people with Nociceptive Pain and Pain, Postoperative, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
General anesthesia is a combination of hypnotic drugs to achieve unconsciousness and opioid analgesics to ensure antinociception. An alternative approach to the intraoperative administration of high potency opioids in order to achieve antinociception during surgery is combining a general anesthesia with a regional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nociceptive Pain, Pain, Postoperative, Analgesia
- What is being tested?
- SPI (Surgical Pleth Index)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 18 Dec 2023to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having elective trauma or orthopaedic surgery with a combination of general and regional anaesthesia
Who cannot join
- Preexisting therapy with beta-blockers, cardiac glycosides or pacemakers
- Cardiac arrhythmia (atrial fibrillation, atrioventricular block > I°)
- Intraoperative treatment with ketamine, beta blockers, beta-adrenergic agonists or clonidine
- Serious peripheral or cardiac autonomic neuropathy
- Inability to specify the postoperative pain level
- Postoperative treatment in an Intensive Care Unit
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center
Hamburg, 20246
About this study
Official title: Effect of Guiding Sufentanil Administration by Surgical Plethysmographic Index (SPI) Monitoring on Intraoperative Sufentanil Consumption in Patients Having Trauma and Orthopaedic Surgery With a Combination of General and Regional Anesthesia
General anesthesia is a combination of hypnotic drugs to achieve unconsciousness and opioid analgesics to ensure antinociception. An alternative approach to the intraoperative administration of high potency opioids in order to achieve antinociception during surgery is combining a general anesthesia with a regional anesthesia.
Modern general anesthesia aims to treat nociception induced by surgical stimulation while avoiding an overdose of opioid analgesics and reducing side-effects of opioid administration. Quality and safety of general anesthesia are of major clinical importance and can be improved by adjusting the opioid analgesics to the optimal individual dose needed.
Read more
In the current clinical practice, the opioid dosage is usually chosen by clinical judgment. Recently different monitoring devices estimating the effect of nociception during unconsciousness have become commercially available. One of the first commercially available nociception indices was the Surgical Pleth Index (SPI) derived by the CARESCAPE™B650 patient monitor (GE Healthcare).
Until today, it remains unknown whether guiding sufentanil administration by SPI monitoring affects the administered amount of intraoperative and postoperative opioid, immediate postoperative pain in the postanesthesia care unit (PACU) and the quality of postoperative recovery in patients with a combination of general and regional anesthesia. This study aims to investigate whether guiding sufentanil administration by SPI monitoring - compared to routine care - reduces intraoperative sufentanil consumption in patients having trauma and orthopaedic surgery with a combination of general and regional anesthesia.
Read the detailed description
General anesthesia is a combination of hypnotic drugs and opioid analgesics. Modern general anesthesia aims to treat nociception induced by surgical stimulation while avoiding an overdose of opioid analgesics and reducing side-effects of opioid administration. Underdosing of opioids during surgery can lead to nociception with increased sympathetic tone, elevated levels of stress hormones, unintended patient movement due to nociception as well as increased postoperative pain. On the other hand, overdosing of opioids can lead to negative side effects such as nausea and vomiting, arterial hypotension, immunosuppression, prolonged recovery times, postoperative delirium and an increase in postoperative pain by opioid-induced-hyperalgesia. Anesthesiologists aim for a long-lasting perioperative anesthesia while at the same time trying to reduce the intraoperative and postoperative opioid administration.
An alternative approach to the intraoperative administration of high potency opioids in order to achieve antinociception during surgery is combining a general anesthesia with a regional anesthesia. However, the quality of regional anesthesia cannot be assessed during general anesthesia by the anesthesiologist and patients cannot express pain themselves. Therefore, anesthesiologists tend to administer a certain calculated opioid dose during the operation. If this calculated opioid administration is essential for a sufficient anesthesia or an unnecessary overdose cannot be assessed by the anesthesiologist. Until now there has been no measurement tool that could estimate the effectiveness of regional anesthesia and the absence of nociception during general anesthesia combined with a regional anesthesia.
In recent years, different monitoring devices estimating the effect of nociception during unconsciousness have become commercially available. Such monitoring devices should help physicians to choose the right dose of opioid analgesics during general anesthesia. Among those, the Surgical Pleth Index (SPI) was one of the first commercially available nociception monitoring devices. The SPI is derived by the CARESCAPE™B650 patient monitor (GE Healthcare) and calculates an index value from normalized heart rate and pulse wave amplitude derived by photoplethysmography. The index is presented on a scale from 0 (low sympathetic tone) to 100 (high sympathetic tone). Nevertheless, current literature is inconclusive about the impact of nociception-monitor-guided opioid administration. So far, there is no definitive evidence on anesthesia related outcome parameters like the administered amount of opioid, postoperative short-term recovery, and long-term outcome. Besides, there has been no study evaluating the assessment of the effectiveness of regional anesthesia during general anesthesia by monitoring the intraoperative nociception with the SPI. If the SPI was able to assess nociception, SPI guided opioid administration would prevent unnecessary opioid administration during the operation and reduce the total dose of opioids. Reduction of the intraoperative opioid dose would mean a clinically important benefit for patients against the background of potential risks of opioid administration. Nevertheless, it remains unknown whether guiding sufentanil administration by SPI monitoring effects the administered amount of intraoperative and postoperative opioid, immediate postoperative pain in the postanesthesia care unit (PACU) and the quality of postoperative recovery in patients with a combination of general and regional anesthesia.
This prospective, randomized controlled trial aims to investigate whether guiding sufentanil administration by SPI monitoring - compared to routine care - reduces intraoperative sufentanil consumption in patients having trauma and orthopaedic surgery with a combination of general and regional anesthesia. The hypothesis tested in the present study is that in patients having trauma and orthopaedic surgery with a combination of general and regional anesthesia guiding sufentanil administration of sufentanil guided by SPI monitoring reduces intraoperative sufentanil consumption compared to routine care.
- Being tested
- SPI (Surgical Pleth Index)
- Keywords
- General Anesthesia, Regional Anesthesia, Analgesia Monitoring
- Medical subject headings
- Nociceptive Pain, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI (Surgical Pleth Index)Procedure or surgery
Elective surgery in patients having trauma and orthopedic surgery with a combination of general and regional anesthesia. Opioid titration is guided by SPI during general anesthesia in the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| SPI (Surgical Pleth Index) | Experimental | Opioid administration (sufentanil) guided by by Surgical Pleth Index (SPI) derived from photoplethysmography performed by the device CARESCAPE B650 Patient Monitor from the manufacturer GE (General Electric) Healthcare, Boston, Massachusetts, US. Included in the monitoring system is a software that continuously calculates the SPI from normalized heart rate and pulse wave amplitude derived from finger photoplethysmography. The numerical index ranges between 0 (low sympathetic tone) and 100 (high sympathetic tone). A SPI score between 20 and 50 has been proposed as the target range to guide opioid analgesics. 5 µg Sufentanil will be administered every 5 minutes if SPI score is calculated more than 50. Receives: Procedure: SPI (Surgical Pleth Index) |
| Control | No intervention | Opioid administration (sufentanil) guided according to standard clinical practice of the attending anesthesiologist based upon changes of heart rate, blood pressure, lacrimation, sweating and spontaneous movements of the patient. As an orientation anesthesiologists are advised to administer 5 µg sufentanil if systolic blood pressure is > 140 mmHg or mean blood pressure is > 100 mmHg or heart rate is > 90 /min. If assessed necessary, the anaesthesiologists are allowed to administer higher or lower sufentanil doses up to their discretion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Sufentanil Consumption
Compares the amount of intraoperative opioid administration (sufentanil) per minute of general anesthesia and per kg bodyweight between groups.
Measured: 1 day
Secondary outcomes (8)
Highest postoperative pain level at the PACU
Postoperative pain level measured with the highest score in Numeric Rating Scale (NRS) at the postanesthesia care unit (PACU) with a minimum of 0 and a maximum of 10 values. Higher scores mean a worse outcome.
Measured: 1 day
Median postoperative pain level at the PACU
Postoperative pain level measured with the median score in Numeric Rating Scale (NRS) at the postanesthesia care unit (PACU) with a minimum of 0 and a maximum of 10 values. Higher scores mean a worse outcome.
Measured: 1 day
Incidence of moderate to severe postoperative pain
Incidence of moderate to severe postoperative pain (NRS 4-10) at the postanesthesia care unit (PACU)
Measured: 1 day
Postoperative opioids
Postoperative administered amount of opioids in morphine equivalents (mg) at the postanesthesia care unit (PACU)
Measured: 1 day
PONV
Incidence of postoperative nausea and vomiting (PONV) at the postanesthesia care unit (PACU)
Measured: 1 day
PACU stay
Length of stay at the postanesthesia care unit (PACU) (min) until patients reach fit-for-discharge status
Measured: 1 day
Pain after 24 hours
Postoperative pain level at rest measured with the Numeric Rating Scale (NRS) 24 hours after the operation on the ward with a minimum of 0 and a maximum of 10 values. Higher scores mean a worse outcome.
Measured: 2 days
Quality-of-Recovery (QoR-15)
Quality of postoperative recovery measured with the Quality-of-Recovery (QoR-15) Score 24 hours after the operation on the ward with a minimum of 0 and a maximum of 150 values. Higher scores mean a better outcome.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start18 Dec 2023
- Primary completion9 Apr 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nociceptive PainStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to intervention groups by chance
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Nitzschke, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040307
- Sponsor's protocol ID
- 2023-08
- Acronym
- GORA
- Status last verified
- May 2024
- First submitted
- 8 Sep 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koschmieder KC, Pinnschmidt HO, Borst LS, Greiwe G, Kainz E, Fischer M, Nitzschke R. Opioid administration guided by Surgical Pleth Index in patients with a combination of general and regional anaesthesia during trauma and orthopaedic surgery: a double-blind, randomised controlled trial. J Clin Monit Comput. 2026 Apr;40(2):489-499. doi: 10.1007/s10877-025-01363-2. Epub 2025 Oct 3.
PubMed 41042488
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Guiding Sufentanil Administration by Surgical Plethysmographic Index (SPI) Monitoring on Intraoperative Sufentanil Consumption in Patients Having Trauma and Orthopaedic Surgery With a Combination of General and Regional Anesthesia
- ClinicalTrials.gov ID
- NCT06040307
- Acronym / sponsor ID
- GORA / 2023-08
- Keywords
- General Anesthesia, Regional Anesthesia, Analgesia Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
General anesthesia is a combination of hypnotic drugs to achieve unconsciousness and opioid analgesics to ensure antinociception. An alternative approach to the intraoperative administration of high potency opioids in order to achieve antinociception during surgery is combining a general anesthesia with a regional anesthesia.
Modern general anesthesia aims to treat nociception induced by surgical stimulation while avoiding an overdose of opioid analgesics and reducing side-effects of opioid administration. Quality and safety of general anesthesia are of major clinical importance and can be improved by adjusting the opioid analgesics to the optimal individual dose needed.
In the current clinical practice, the opioid dosage is usually chosen by clinical judgment. Recently different monitoring devices estimating the effect of nociception during unconsciousness have become commercially available. One of the first commercially available nociception indices was the Surgical Pleth Index (SPI) derived by the CARESCAPE™B650 patient monitor (GE Healthcare).
Until today, it remains unknown whether guiding sufentanil administration by SPI monitoring affects the administered amount of intraoperative and postoperative opioid, immediate postoperative pain in the postanesthesia care unit (PACU) and the quality of postoperative recovery in patients with a combination of general and regional anesthesia. This study aims to investigate whether guiding sufentanil administration by SPI monitoring - compared to routine care - reduces intraoperative sufentanil consumption in patients having trauma and orthopaedic surgery with a combination of general and regional anesthesia.
Detailed description
General anesthesia is a combination of hypnotic drugs and opioid analgesics. Modern general anesthesia aims to treat nociception induced by surgical stimulation while avoiding an overdose of opioid analgesics and reducing side-effects of opioid administration. Underdosing of opioids during surgery can lead to nociception with increased sympathetic tone, elevated levels of stress hormones, unintended patient movement due to nociception as well as increased postoperative pain. On the other hand, overdosing of opioids can lead to negative side effects such as nausea and vomiting, arterial hypotension, immunosuppression, prolonged recovery times, postoperative delirium and an increase in postoperative pain by opioid-induced-hyperalgesia. Anesthesiologists aim for a long-lasting perioperative anesthesia while at the same time trying to reduce the intraoperative and postoperative opioid administration.
An alternative approach to the intraoperative administration of high potency opioids in order to achieve antinociception during surgery is combining a general anesthesia with a regional anesthesia. However, the quality of regional anesthesia cannot be assessed during general anesthesia by the anesthesiologist and patients cannot express pain themselves. Therefore, anesthesiologists tend to administer a certain calculated opioid dose during the operation. If this calculated opioid administration is essential for a sufficient anesthesia or an unnecessary overdose cannot be assessed by the anesthesiologist. Until now there has been no measurement tool that could estimate the effectiveness of regional anesthesia and the absence of nociception during general anesthesia combined with a regional anesthesia.
In recent years, different monitoring devices estimating the effect of nociception during unconsciousness have become commercially available. Such monitoring devices should help physicians to choose the right dose of opioid analgesics during general anesthesia. Among those, the Surgical Pleth Index (SPI) was one of the first commercially available nociception monitoring devices. The SPI is derived by the CARESCAPE™B650 patient monitor (GE Healthcare) and calculates an index value from normalized heart rate and pulse wave amplitude derived by photoplethysmography. The index is presented on a scale from 0 (low sympathetic tone) to 100 (high sympathetic tone). Nevertheless, current literature is inconclusive about the impact of nociception-monitor-guided opioid administration. So far, there is no definitive evidence on anesthesia related outcome parameters like the administered amount of opioid, postoperative short-term recovery, and long-term outcome. Besides, there has been no study evaluating the assessment of the effectiveness of regional anesthesia during general anesthesia by monitoring the intraoperative nociception with the SPI. If the SPI was able to assess nociception, SPI guided opioid administration would prevent unnecessary opioid administration during the operation and reduce the total dose of opioids. Reduction of the intraoperative opioid dose would mean a clinically important benefit for patients against the background of potential risks of opioid administration. Nevertheless, it remains unknown whether guiding sufentanil administration by SPI monitoring effects the administered amount of intraoperative and postoperative opioid, immediate postoperative pain in the postanesthesia care unit (PACU) and the quality of postoperative recovery in patients with a combination of general and regional anesthesia.
This prospective, randomized controlled trial aims to investigate whether guiding sufentanil administration by SPI monitoring - compared to routine care - reduces intraoperative sufentanil consumption in patients having trauma and orthopaedic surgery with a combination of general and regional anesthesia. The hypothesis tested in the present study is that in patients having trauma and orthopaedic surgery with a combination of general and regional anesthesia guiding sufentanil administration of sufentanil guided by SPI monitoring reduces intraoperative sufentanil consumption compared to routine care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to intervention groups by chance
| Arm | Type | Receives |
|---|---|---|
| SPI (Surgical Pleth Index) | Experimental | Procedure: SPI (Surgical Pleth Index)Opioid administration (sufentanil) guided by by Surgical Pleth Index (SPI) derived from photoplethysmography performed by the device CARESCAPE B650 Patient Monitor from the manufacturer GE (General Electric) Healthcare, Boston, Massachusetts, US. Included in the monitoring system is a software that continuously calculates the SPI from normalized heart rate and pulse wave amplitude derived from finger photoplethysmography. The numerical index ranges between 0 (low sympathetic tone) and 100 (high sympathetic tone). A SPI score between 20 and 50 has been proposed as the target range to guide opioid analgesics. 5 µg Sufentanil will be administered every 5 minutes if SPI score is calculated more than 50. |
| Control | No intervention | –Opioid administration (sufentanil) guided according to standard clinical practice of the attending anesthesiologist based upon changes of heart rate, blood pressure, lacrimation, sweating and spontaneous movements of the patient. As an orientation anesthesiologists are advised to administer 5 µg sufentanil if systolic blood pressure is > 140 mmHg or mean blood pressure is > 100 mmHg or heart rate is > 90 /min. If assessed necessary, the anaesthesiologists are allowed to administer higher or lower sufentanil doses up to their discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having elective trauma or orthopaedic surgery with a combination of general and regional anaesthesia
Key exclusion criteria (6 listed)
- Preexisting therapy with beta-blockers, cardiac glycosides or pacemakers
- Cardiac arrhythmia (atrial fibrillation, atrioventricular block > I°)
- Intraoperative treatment with ketamine, beta blockers, beta-adrenergic agonists or clonidine
- Serious peripheral or cardiac autonomic neuropathy
- Inability to specify the postoperative pain level
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 |
|---|---|---|
| SPI (Surgical Pleth Index)Elective surgery in patients having trauma and orthopedic surgery with a combination of general and regional anesthesia. Opioid titration is guided by SPI during general anesthesia in the experimental arm. | Procedure or surgery | SPI (Surgical Pleth Index) |
Primary outcome
Intraoperative Sufentanil Consumption
Time frame: 1 day
Compares the amount of intraoperative opioid administration (sufentanil) per minute of general anesthesia and per kg bodyweight between groups.
8 secondary outcomes
Highest postoperative pain level at the PACU
Time frame: 1 day
Median postoperative pain level at the PACU
Time frame: 1 day
Incidence of moderate to severe postoperative pain
Time frame: 1 day
Postoperative opioids
Time frame: 1 day
PONV
Time frame: 1 day
PACU stay
Time frame: 1 day
Pain after 24 hours
Time frame: 2 days
Quality-of-Recovery (QoR-15)
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Derived from this study: PubMed 41042488Koschmieder KC, Pinnschmidt HO, Borst LS, Greiwe G, Kainz E, Fischer M, Nitzschke R. Opioid administration guided by Surgical Pleth Index in patients with a combination of general and regional anaesthesia during trauma and orthopaedic surgery: a double-blind, randomised controlled trial. J Clin Monit Comput. 2026 Apr;40(2):489-499. doi: 10.1007/s10877-025-01363-2. Epub 2025 Oct 3.
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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.
Rainer Nitzschke, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPI (Surgical Pleth Index) in people with Nociceptive Pain and Pain, Postoperative, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 1 inclusion and 6 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 13 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intraoperative Sufentanil Consumption (time frame: 1 day). 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 NCT06040307, which also lists 1 linked publication.
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 13 May 2024.