Clinical trial NCT04202250: The Efficacy of Continuous Femoral Nerve Catheter Orifice Configuration for Postoperative Analgesia in Knee Arthroplasty
Official title: Comparison of the Efficacy of Single-port Open-ended Catheter and Closed-end Multiport Catheters for Continuous Femoral Nerve Blockade for Postoperative Analgesia in Patients Undergoing Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Catheter Blockage
Knee Arthropathy
Pain, Postoperative
Keywords: femoral nerve catheter
Total Knee Arthroplasty
Catheter tips configurations
continuous nerve block
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomized to the catheter tip configuration as CEMP (closed-ended multiport catheter) group and OESP (open-ended single port catheter) group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: numeric rating scale (NRS)
timeFrame: three days postoperatively
measure: use of patient control analgesia
timeFrame: three days postoperatively
measure: complications related to opioids
timeFrame: three days postoperatively
measure: the requirement for additional analgesia
timeFrame: three days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
state: Keçiören
Study officials:
affiliation: Gulhane Training and Research Hospital
name: Mehmet B EŞKİN, M.D.
role: STUDY_DIRECTOR
affiliation: Gulhane Training and Research Hospital
name: Ayşegül Ceylan
role: PRINCIPAL_INVESTIGATOR
References: