Guiding Opioid Administration in Patients With Regional Anesthesia

NCT06040307 | Completed

• 1 other identifier: 2023-08
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Nociceptive Pain; Pain, Postoperative; Analgesia; Anesthesia Recovery Period; Opioid Use

Keywords

General Anesthesia; Regional Anesthesia; Analgesia Monitoring

Outcome Measures

Primary Outcomes (1)

• Intraoperative Sufentanil Consumption

  Compares the amount of intraoperative opioid administration (sufentanil) per minute of general anesthesia and per kg bodyweight between groups.

  1 day

Secondary Outcomes (8)

• Highest postoperative pain level at the PACU

  1 day

• Median postoperative pain level at the PACU

  1 day

• Incidence of moderate to severe postoperative pain

  1 day

• Postoperative opioids

  1 day

• PONV

  1 day

Study Arms (2)

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.

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.

Interventions

SPI (Surgical Pleth Index) PROCEDURE

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.

SPI (Surgical Pleth Index)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having elective trauma or orthopaedic surgery with a combination of general and regional anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center

Hamburg, 20246, Germany

Location

Related Publications (1)

• 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. 2025 Oct 3. doi: 10.1007/s10877-025-01363-2. Online ahead of print.

  PMID: 41042488 DERIVED

MeSH Terms

Conditions

Nociceptive Pain; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Rainer Nitzschke, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single-blinded to the primary endpoint (intraoperative amount of sufentanil). Participants are not informed about the group assignment (intervention takes place in general anesthesia). The attending anesthesiologists can not be blinded to the group-allocation, because the study involves intervention during the intraoperative treatment. The study is double-blinded regarding the secondary endpoints. Postoperative outcome parameters are assessed by members of the study team. These outcome-assessors are blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to intervention groups by chance

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: December 18, 2023
• Primary Completion: April 9, 2024
• Study Completion: May 6, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

DE (1)