The Efficacy of Continuous Femoral Nerve Catheter Orifice Configuration for Postoperative Analgesia in Knee Arthroplasty

Gulhane School of Medicine

Status: Completed

Conditions: Pain, Postoperative; Knee Arthropathy; Catheter Blockage; Anesthesia

Treatments: Procedure: CEMP (closed-ended multiport catheter) group; Procedure: OESP (open-ended single port catheter) group

Study type: Interventional

Funder types: Other

Identifiers

NCT04202250

19/397

Details and patient eligibility

About

Femoral nerve catheter for postoperative analgesia will be included in the adult patients undergoing total knee arthroplasty included in the study. These patients will be randomized to the catheter tip configuration as CEMP (closed-ended multiport catheter) group and OESP (open-ended single port catheter) group. Patient controlled analgesia device will be attached to the peripheral nerve catheter of these patients. Demographic data of the patients , the number of pushing the button the amount of bolus dose given, and the total dose given in the patient controlled anesthesia device, the need for additional analgesia and the amount, pain scores, complications will be recorded for three days postoperatively. Records will be compared statistically.

Full description

Ethics committee approval was received on 10 December 2019, numbered 19/397. The study was planned to include 90 adult patients undergoing total knee arthroplasty at Gülhane Training and Research Hospital between 10 December 2019 and April 2020. Continue femoral nerve catheter for postoperative analgesia will be included in the patients included in the study. These patients will be randomized to the catheter tip configuration as CEMP (closed-ended multiport catheter) group and OESP (open-ended single port catheter) group. Patient controlled analgesia device will be attached to the peripheral nerve catheter of these patients. Demographic data of the patients who have placed an femoral nerve catheter and used the catheter successfully for three days postoperatively, the number of pushing the button, the amount of bolus dose given and the total dose given in the patient controlled anesthesia device,the amounts of need for additional analgesia and pain scores(Numeric rating Scale), complications will be recorded for three days postoperatively. Records will be compared statistically.

Enrollment: 80 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) Score I-III
• upper extremity surgery

Exclusion criteria

• emergency surgery,
• secondary surgery,
• chronic pain treatment
• pregnancy,
• any contraindication to peripheral nerve blockade,
• pre-existing peripheral nerve neuropathy,
• allergy to LA (study medications),
• ASA score ≥ 4,
• neurologic or neuromuscular disease,
• psychiatric disease,
• renal failure,
• hepatic failure,
• NSAID contraindication,
• inability to use a patient controlled analgesia (PCA) device,
• infection at the injection site
• withdrawal of consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

CEMP (closed-ended multiport catheter) group

Active Comparator group

Description:

closed-ended multiport femoral nerve catheter will be included in the patients undergoing total knee arthroplasty surgery for postoperative analgesia

Treatment:

Procedure: CEMP (closed-ended multiport catheter) group

OESP (open-ended single port catheter) group

Active Comparator group

Description:

open-ended single port femoral nerve catheter will be included in the patients undergoing total knee arthroplasty surgery for postoperative analgesia

Treatment:

Procedure: OESP (open-ended single port catheter) group