RecruitingNot ApplicableNCT06732050

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

Influence of Intraoperative Nociception Guided Analgesia on Perioperative Analgesia Consumption in Patients Undergoing Laparoscopic Resection of Endometriosis


Sponsor

Prof Urs Zingg

Enrollment

120 participants

Start Date

Aug 6, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria7

  • 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)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEnociception 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.


Locations(1)

Spital Limmattal

Schlieren, Canton of Zurich, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06732050