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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06236035
Other study ID # 2022/04-21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date January 1, 2024

Study information

Verified date February 2024
Source Zonguldak Bulent Ecevit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date January 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Analgesia nociception index
a device to assess patient's pain during surgery

Locations

Country Name City State
Turkey Zonguldak Bülent Ecevit University Zonguldak Kozlu

Sponsors (1)

Lead Sponsor Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary intraoperatively total opioid consumption total remifentanil consumption during surgery during the surgery
Secondary pain scores assessment pain scores by numeric rating scale (min:0, max:10) up to 24 hours after surgery
Secondary postoperatif analgesic requirement need for analgesics after surgery up to 24 hours after surgery
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