Clinical trial NCT06236035: Intraoperative Analgesia Based on ANI
Official title: Intraoperative Analgesia Management by Monitoring Analgesia Nociception Index (ANI) in Total Knee Arthroplasty With Femoral Nerve Block: a Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain Monitoring
Pain Assessment
Opioid Consumption
Keywords: Analgesia nociception index
opioid consumption
Pain management
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18-75 years old, ASA I-II-III risk group, undergo knee operation under general anesthesia

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.


Eligibility criteria: 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

Primary outcomes:
measure: intraoperatively total opioid consumption
timeFrame: during the surgery
Secondary outcomes:
measure: pain scores
timeFrame: up to 24 hours after surgery
measure: postoperatif analgesic requirement
timeFrame: up to 24 hours after surgery
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
state: Kozlu
Study officials:
References: