Intraoperative Analgesia Based on ANI

NCT ID: NCT06236035

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-01-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group Control

No interventions assigned to this group

Group ANI

Analgesia nociception index

Intervention Type: DEVICE

a device to assess patient's pain during surgery

Interventions

Analgesia nociception index

a device to assess patient's pain during surgery

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zonguldak Bulent Ecevit University

OTHER

Sponsor Role: lead

Responsible Party

Keziban Bollucuoglu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zonguldak Bülent Ecevit University

Zonguldak, Kozlu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022/04-21

Identifier Type: -

Identifier Source: org_study_id