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Clinical Trials/NCT06236035
NCT06236035
Completed
Not Applicable

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

Zonguldak Bulent Ecevit University1 site in 1 country1 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain Monitoring
Sponsor
Zonguldak Bulent Ecevit University
Enrollment
1
Locations
1
Primary Endpoint
intraoperatively total opioid consumption
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
January 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Zonguldak Bulent Ecevit University
Responsible Party
Principal Investigator
Principal Investigator

Keziban Bollucuoglu

Principal Investigator

Zonguldak Bulent Ecevit University

Eligibility Criteria

Inclusion Criteria

  • 1.18-75 years old, 2.ASA I-II-III risk group 3.undergo knee operation under general anesthesia
  • Patients with preoperative femoral nerve block
  • Patients whose informed consent was read and consent was obtained from them and their guardian

Exclusion Criteria

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

Outcomes

Primary Outcomes

intraoperatively total opioid consumption

Time Frame: during the surgery

total remifentanil consumption during surgery

Secondary Outcomes

  • pain scores(up to 24 hours after surgery)
  • postoperatif analgesic requirement(up to 24 hours after surgery)

Study Sites (1)

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