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

NCT06732050 | Completed

• 1 other identifier: 2024-00822
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Analgesia in Endometriosis

Keywords

endometriosis surgery; perioperative analgesia

Outcome Measures

Primary Outcomes (1)

• Total analgestic requirement

  Total analgesic requirement. Intra- and postoperative medication administration will be systematically documented throughout until two hours after arrival at the recovery room or until the patient has been discharged from the recovery room.

  Start of anaesthesia until discharge from the recovery room (max. lenghth of stay in the recovery 2 hours)..

Secondary Outcomes (3)

• Postoperative Numeric Rating Scale (NRS) scores in PACU

  Start Start at arrival in the recovery room until discharge from the recovery room (max. lenghth of stay in the recovery 2 hours)

• Total length of Stay in the PACU (min)

  Start at arrival in the recovery room until discharge from the recovery room (max. lenghth of stay in the recovery 2 hours)

• Postoperative Numeric Rating Scale (NRS) scores at discharge

  Immediately postoperatively until discharge (1-3 days).

Study Arms (2)

Control group

NO INTERVENTION

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.

nociception guided treatment

EXPERIMENTAL

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.

Device: nociception guided treatment

Interventions

nociception guided treatment 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.

nociception guided treatment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Prof Urs Zingg: lead

Study Sites (1)

Spital Limmattal

Schlieren, Canton of Zurich, 8952, Switzerland

Location

Study Officials

• Isabel Marcolino, Dr. med.

  Spital STS AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Urs Zingg

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: December 13, 2024
• Study Start: August 6, 2024
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CH (1)