Influence of Intraoperative Nociception Guided Analgesia on Perioperative Total Analgesic Requirement Endometriosis

NCT ID: NCT06732050

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-06
• Study Completion Date: 2025-10-01

Brief Summary

Adequate analgesia in the perioperative setting is one of the most important pillars of anesthesiology. It is generally understood that poorly managed acute postoperative pain correlates with increased morbidity, prolonged recovery periods, extended opioid utilization, and serves as a predictor for chronic pain onset . On the other hand, the overuse of opioid-based analgesics during surgery may evoke respiratory depression, constipation, nausea, sedation, and opioid-induced hyperalgesia . Thus far, the lack of an objective intraoperative pain monitor has constrained anesthesia practitioners to rely on the interpretation of physiological cues such as tachycardia, hypertonia, and lacrimation as surrogate markers of pain (3). Variability in the educational background and clinical experience among providers may predispose to either excessive or inadequate administration of analgesics, consequently allowing for unfavorable postoperative outcomes. However, recent advancements have introduced novel devices for nociception measurement. Thus, a quantifiable assessment of nociception has become feasible. The most widely approved device is the Nociception Level (NOL®) index developed by Medasense in Israel. This index operates by discerning various sympathetic responses of the body to nociceptive stimuli and has been thoroughly tested on opioid-based analgesic regimens. The NOL® index uses a multiparametric approach including a random forest algorithm to measure the balance between sympathetic and parasympathetic system activity. Recently, a strong correlation has been reported between the response of the NOL® index and analgesia during surgery.

Patients being scheduled for endometriosis surgery do have a significant history of chronic pain thus being more prone to postoperative complications and therefore will benefit the most from a tailored analgesic regimen.

Detailed Description

Adequate analgesia in the perioperative setting is one of the most important pillars of anaesthesiology. It is generally understood that poorly managed acute postoperative pain correlates with increased morbidity, prolonged recovery periods, extended opioid utilization, and serves as a predictor for chronic pain onset. On the other hand, the overuse of opioid-based analgesics during surgery may evoke respiratory depression, constipation, nausea, sedation, and opioid-induced hyperalgesia. Thus far, the lack of an objective intraoperative pain monitor has constrained anaesthesia practitioners to rely on the interpretation of physiological cues such as tachycardia, hypertonia, and lacrimation as surrogate markers of pain. Variability in the educational background and clinical experience among providers may predispose to either excessive or inadequate administration of analgesics, consequently allowing for unfavorable postoperative outcomes. However, recent advancements have introduced novel devices for nociception measurement. Thus, a quantifiable assessment of nociception has become feasible. The most widely approved device is the Nociception Level (NOL®) index developed by Medasense in Israel. This index operates by discerning various sympathetic responses of the body to nociceptive stimuli and has been thoroughly tested on opioid-based analgesic regimens. The NOL® index uses a multiparametric approach including a random forest algorithm to measure the balance between sympathetic and parasympathetic system activity. Recently, a strong correlation has been reported between the response of the NOL® index and analgesia during surgery.

Patients being scheduled for endometriosis surgery do have a significant history of chronic pain thus being more prone to postoperative complications and therefore will benefit the most from a tailored analgesic regimen. Patients' existing analgesic regimen, typically comprising Paracetamol, NSAIDs, and Metamizol, will be carefully documented during preoperative anesthetic consultations and taken into account in the study protocols.

Preoperatively, patients will be staged by their gynecologists using the ENZIAN classification. The ENZIAN classification is a diagnostic system for endometriosis that covers various localizations and forms of the disease. It enables a standardized assessment for both non-invasive and invasive diagnostic procedures. The classification considers specific compartments and uses standardized coding for the severity and location of lesions. The classification is performed preoperatively using ultrasound diagnostics as well as intraoperatively and is annotated with the lower-case letters: (s)= Surgical, (u)= Ultrasound (Keckstein J, 2021). Thereby, a comprehensive picture of the disease is obtained. Deeply infiltrating endometriosis requires a more invasive procedure, a longer operating time and a higher consumption of analgesics.

Conditions

Perioperative Analgesia in Endometriosis

Keywords

endometriosis surgery; perioperative analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Control group

The control group will undergo standard treatment for laparoscopic endometriosis/adenomyosis surgery at Spital Limmattal. Although the control group will not be using NOL®-monitoring to guide analgesic requirement, the monitor will be installed with a blinded screen to investigate whether our multimodal anesthesia model is in coherence with values between 10 and 25. The anesthesia care team will not be able to see the values during surgery in order to tailor analgesic requirement only by conventional clinical judgement.

Group Type: NO_INTERVENTION

No interventions assigned to this group

nociception guided treatment

For the nociception level-guided group the same standard narcosis will be applied whilst ensuring that the NOL® level value will be maintained between 10 and 25.

Group Type: EXPERIMENTAL

nociception guided treatment

Intervention Type: DEVICE

For the nociception level-guided group the same standard narcosis will be applied whilst ensuring that the NOL® level value will be maintained between 10 and 25.

Interventions

nociception guided treatment

For the nociception level-guided group the same standard narcosis will be applied whilst ensuring that the NOL® level value will be maintained between 10 and 25.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Premenopausal females
• Undergoes any type of laparoscopic surgery for suspected endometriosis or adenomyosis (diagnostic/therapeutic and/or hysterectomy)

Exclusion Criteria

• Age < 18 years
• Patients with contraindications for opioids and/or ketamine/clonidine (standard medications)
• Pregnant or breastfeeding women
• Lack of ability to follow the study procedure, e.g. due to severe language barriers, mental disorders, dementia
• Patients requiring preoperative or postoperative treatment in the intensive care unit
• Patients with conditions precluding the use of the NOL® sensor, such as neuromuscular deficits affecting hand function
• Regular consumption of opioids (Mankoski Score ≥6)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prof Urs Zingg

OTHER

Sponsor Role: lead

Responsible Party

Prof Urs Zingg

Prof. Dr. med. Urs Zingg

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Isabel Marcolino, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Spital STS AG

Locations

Spital Limmattal

Schlieren, Canton of Zurich, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Isabel Marcolino, Dr. med.

Role: CONTACT

Phone: 044 736 82 18

Email: isabel.marcolino@spital-limmattal.ch

Paul Ranner

Role: CONTACT

Phone: 044 736 88 05

Email: paul.ranner@spital-limmattal.ch

Facility Contacts

Isabel Marcolino, Dr. med.

Role: primary

Patrizia Heeb

Role: backup

Other Identifiers

2024-00822

Identifier Type: -

Identifier Source: org_study_id