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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202250
• Other study ID #: 19/397
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: May 10, 2020

Study information

• Verified date: May 2020
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 10, 2020
• Est. primary completion date: April 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Catheter Blockage
• Joint Diseases
• Knee Arthropathy
• Pain, Postoperative

Intervention

Procedure:
• CEMP (closed-ended multiport catheter) group
After sterile preparation and large inguinal crease draping, with the US probe in a sterile sleeve or cover , we will proceed to hydrolocalization with 5-10 mL 5% dextrose in order to open the space between the femoral nerve and the superior part of the ilio-psoas muscle. The Contiplex® FX Non-Stimulating Tuohy Set, 17Ga. x 3½ inches. the Non-Stimulating Needle and the closed-tip multiport catheter will be then inserted under control and its position assessed between the femoral nerve and the superior aspect of the ilio-psoas muscle. Some aliquots of 5% dextrose will inject to confirm correct dispersal of the solution along the femoral nerve. The catheter will be tunnelled subcutaneously.A patient-controlled analgesic device will be attached to the catheter for postoperative analgesia. continuous peripheral nerve patient-controlled analgesia is as follows: 0.125% bupivacaine; hourly infusion: 4 ml / hour, pca dose (bolus): 5 ml / hour, lock-up time: 30 min, 4-hours limit: 30 ml.
• OESP (open-ended single port catheter) group
After sterile preparation and large inguinal crease draping, with the US probe in a sterile sleeve or cover , we will proceed to hydrolocalization with 5-10 mL 5% dextrose in order to open the space between the femoral nerve and the superior part of the ilio-psoas muscle. The Contiplex® FX Non-Stimulating Tuohy Set, 17Ga. x 3½ inches. the Non-Stimulating Needle and the open-ended catheter will be then inserted under control and its position assessed between the femoral nerve and the superior aspect of the ilio-psoas muscle. Some aliquots of 5% dextrose will inject to confirm correct dispersal of the solution along the femoral nerve. The catheter will be tunnelled subcutaneously. A patient-controlled analgesic device will be attached to the catheter for postoperative analgesia. continuous peripheral nerve patient-controlled analgesia is as follows: 0.125% bupivacaine; hourly infusion: 4 ml / hour, pca dose (bolus): 5 ml / hour, lock-up time: 30 min, 4-hours limit: 30 ml.

Locations

Country	Name	City	State
Turkey	Gulhane Training and Research Hospital	Ankara	Keçiören

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numeric rating scale (NRS)	Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)	three days postoperatively
Primary	use of patient control analgesia	The number of PCA button presses, the total amount of local anesthetics applied	three days postoperatively
Primary	complications related to opioids	Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration,	three days postoperatively
Primary	the requirement for additional analgesia	Additional analgesic dexketoprofen (trometamol) 50 mg / 2 ml will be administered intravenously as rescue analgesia to patients with an NRS score above 3 and recorded.	three days postoperatively