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CompletedNCT04205695Updated Mar 6, 2020

Comparison of Catheters Orifice Configuration For Continuous Infraclavicular Analgesia

An interventional study of CEMP (closed-ended multiport catheter) group and OESP (open-ended single port catheter) group in Pain, Postoperative, Catheter Blockage and Anesthesia, sponsored by Gulhane School of Medicine. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-03-06.

Sponsored by Gulhane School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain, Postoperative
  • Catheter Blockage
  • Anesthesia

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Keywords

  • infraclavicular catheter
  • upper extremity surgery
  • Postoperative analgesia
  • continuous nerve block
  • Catheter tips configurations
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 70 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Gulhane School of Medicine is the lead sponsor of 66 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • 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 · Procedure: Patient-controlled analgesia

  • 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: OESP (open-ended single port catheter) group · Procedure: Patient-controlled analgesia

Interventions

  • ProcedureCEMP (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.

  • ProcedureOESP (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.

  • ProcedurePatient-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.

06

What researchers measure

Primary outcomes

  1. numeric rating scale (NRS)

    Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)

    Time frame: three days postoperatively

  2. data from patient-controlled analgesia (PCA) device

    The number of PCA button presses

    Time frame: three days postoperatively

  3. 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.

    Time frame: three days postoperatively

  4. complications related to opioids

    Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration,

    Time frame: three days postoperatively

  5. 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.

    Time frame: three days postoperatively

07

Study locations

1 site
  • Gulhane Training and Research Hospital
    Ankara, Keçiören 06100, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04205695
Lead sponsor
Gulhane School of Medicine
Responsible party
Mehmet Burak Eşkin (Assistant Professor, Gulhane School of Medicine) — Principal investigator
First posted
Dec 19, 2019
Start date
Dec 10, 2019
Primary completion
Feb 12, 2020
Completion
Feb 28, 2020
Last update
Mar 6, 2020

Study contacts

Mehmet B EŞKİN, M.D.
study director · Gulhane Training and Research Hospital
Ayşegül Ceylan
principal investigator · Gulhane Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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