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Intraoperative Analgesia Based on ANI

Intraoperative Analgesia Management by Monitoring Analgesia Nociception Index (ANI) in Total Knee Arthroplasty With Femoral Nerve Block: a Randomized Controlled Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06236035
Enrollment
1
Registered
2024-02-01
Start date
2022-03-01
Completion date
2024-01-01
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Monitoring, Pain Assessment, Opioid Consumption

Keywords

Analgesia nociception index, opioid consumption, Pain management

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.

Interventions

a device to assess patient's pain during surgery

Sponsors

Zonguldak Bulent Ecevit University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

1.18-75 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

Exclusion criteria

1. Those who do not want to participate in the study, 2. ASA IV-V patients 3. Those with central or autonomic nervous system disease

Design outcomes

Primary

MeasureTime frameDescription
intraoperatively total opioid consumptionduring the surgerytotal remifentanil consumption during surgery

Secondary

MeasureTime frameDescription
pain scoresup to 24 hours after surgeryassessment pain scores by numeric rating scale (min:0, max:10)
postoperatif analgesic requirementup to 24 hours after surgeryneed for analgesics after surgery

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026