Comparison of Catheters Orifice Configuration For Continuous Infraclavicular Analgesia

Anesthesia Clinical Trial

Official title:

Comparison of Open-tip End-hole and Close-tip Triple-hole Catheters For Continuous Infraclavicular Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205695
• Other study ID #: 19/398
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: February 28, 2020

Study information

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

Clinical Trial Summary

Infraclavicular nerve catheter for postoperative analgesia will be included in the 70 adult patients undergoing upper extremity surgery 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 number of pushing the button, the amount of bolus dose given, 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 19/398. The study was planned to include 70 adult patients undergoing upper extremity surgery at Gulhane Training and Research Hospital between 10 December 2019 and February 2020. Continue infraclavicular 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 infraclavicular 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. Records will be compared statistically.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 28, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 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 local anesthetics (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
• Pain, Postoperative

Intervention

Procedure:
• CEMP (closed-ended multiport catheter) group
The linear probe will be placed parasagittally at the junction between the clavicle and the choroidal process. After medial to lateral scanning, the branches of the brachial plexus will be seen as posterior, lateral and medial truncus around the axillary artery. Contiplex® FX Non-Stimulating Tuohy Set, 17Ga. x 3½ inches. the Non-Stimulating Needle and the closed-tip multiport catheter will be delivered through the needle and placed at the 6 o'clock position relative to the axillary artery and then secured by forming a tunnel under the skin. After negative aspiration, the location of the catheter will be confirmed by injecting 1-2 ml of local anesthetic under ultrasonic guidance.
• OESP (open-ended single port catheter) group
The linear probe will be placed parasagittally at the junction between the clavicle and the choroidal process. After medial to lateral scanning, the branches of the brachial plexus will be seen as posterior, lateral and medial truncus around the axillary artery. Contiplex® Non-Stimulating Tuohy Set, 17Ga. x 3½ inches. hhe Non-Stimulating Needle and the Non-Stimulating open-ended catheter will be delivered through the needle and placed at the 6 o'clock position relative to the axillary artery and then secured by forming a tunnel under the skin. After negative aspiration, the location of the catheter will be confirmed by injecting 1-2 ml of local anesthetic under ultrasonic guidance.
• Patient-controlled analgesia
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	data from patient-controlled analgesia (PCA) device	The number of PCA button presses	three days postoperatively
Primary	Data from patient-controlled analgesia (PCA) device	Total amount (ml) of local anesthetic (0.125% bupivacaine) delivered to patient recorded by patient controlled analgesia device.	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