Intraoperative Analgesia Based on ANI

NCT06236035 | Completed

• 1 other identifier: 2022/04-21
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis of the knee joint is common and total knee arthroplasty (TKA) is performed in patients with advanced joint degeneration, no response to conservative treatments, severe pain and joint instability. Severe pain levels between 4 and 8 in visual analog pain scale (VAS) scores have been reported in the postoperative period. Multimodal analgesia is considered to be the best option for pain control after total knee arthroplasty. Multimodal analgesia is defined as the combined use of different analgesia techniques such as neuraxial analgesia, peripheral nerve blocks, patient-controlled analgesia and different analgesic drugs. For this purpose, peripheral nerve blocks are effectively applied as a component of multimodal analgesia. Thus, side effects such as nausea, vomiting, pruritus and sedation that may occur due to opioid use are reduced. At the same time, in addition to providing effective analgesia, peripheral blocks contribute to early initiation of rehabilitation of the knee joint, early ambulation, reduction of pulmonary complications and early discharge from the hospital. Recently, objective methods such as skin vasomotor reflex analysis, pupilometry, pulse plethysmographic signals and analgesia nociceptive index (ANI) have been used to standardize the need for intraoperative analgesia in patients under general anesthesia. Among these methods, ANI is a non-invasive method that provides continuous measurement of parasympathetic tone, which is a part of the autonomic nervous system. Electrodes are placed on the chest wall on both sides of the heart and the patient is monitored. The investigators aimed to compare the analgesia nociception index (ANI) and the conventional method to determine perioperative analgesic needs in patients undergoing total knee arthroplasty under general anesthesia with femoral nerve block.

Conditions

Pain Monitoring; Pain Assessment; Opioid Consumption

Keywords

Analgesia nociception index; opioid consumption; Pain management

Outcome Measures

Primary Outcomes (1)

• intraoperatively total opioid consumption

  total remifentanil consumption during surgery

  during the surgery

Secondary Outcomes (2)

• pain scores

  up to 24 hours after surgery

• postoperatif analgesic requirement

  up to 24 hours after surgery

Study Arms (2)

Group Control

Group ANI

Device: Analgesia nociception index

Interventions

Analgesia nociception index DEVICE

a device to assess patient's pain during surgery

Group ANI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

18-75 years old, ASA I-II-III risk group, undergo knee operation under general anesthesia

You may qualify if:

• years old, 2.ASA I-II-III risk group 3.undergo knee operation under general anesthesia 4. Patients with preoperative femoral nerve block 5. Patients whose informed consent was read and consent was obtained from them and their guardian

You may not qualify if:

• Those who do not want to participate in the study,
• ASA IV-V patients
• Those with central or autonomic nervous system disease

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: March 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)