Comparison of Catheters Orifice Configuration For Continuous Infraclavicular Analgesia

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Anesthesia; Catheter Blockage
• Intervention / Treatment: Procedure: CEMP (closed-ended multiport catheter) group; Procedure: Patient-controlled analgesia; Procedure: OESP (open-ended single port catheter) group

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Keçiören
    • Ankara, Keçiören, Turkey, 06100
      • Gulhane Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CEMP (closed-ended multiport catheter) group; Infraclavicular closed-ended multiport nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia	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.; Procedure: 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.
Active Comparator: OESP (open-ended single port catheter) group; Infraclavicular open-ended single port nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia	Procedure: 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.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numeric rating scale (NRS)	Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)	three days postoperatively
complications related to opioids	Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration,	three days postoperatively
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
data from patient-controlled analgesia (PCA) device	The number of PCA button presses	three days postoperatively
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

Collaborators and Investigators

• Sponsor: Gulhane School of Medicine
• Investigators: Principal Investigator: Ayşegül Ceylan, Gulhane Training and Research Hospital; Study Director: Mehmet B EŞKİN, M.D., Gulhane Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): February 12, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative analgesia; upper extremity surgery; Catheter tips configurations; continuous nerve block; infraclavicular catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 19/398

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No