Intraoperative Analgesia Based on ANI

Completed

• Conditions: Opioid Consumption; Pain Monitoring; Pain Assessment

• Registration Number: NCT06236035
• Lead Sponsor: Zonguldak Bulent Ecevit University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-01
• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-31
• Status Verified: 2024-02
• Study First Posted: 2024-02-01
• Last Update Submitted: 2024-02-04
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intraoperatively total opioid consumption	during the surgery	total remifentanil consumption during surgery

Secondary Outcome Measures

Name	Time	Method
pain scores	up to 24 hours after surgery	assessment pain scores by numeric rating scale (min:0, max:10)
postoperatif analgesic requirement	up to 24 hours after surgery	need for analgesics after surgery

Trial Locations

Locations (1)

Zonguldak Bülent Ecevit University; 🇹🇷 Zonguldak, Kozlu, Turkey