NCT04205695

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

December 16, 2019

Last Update Submit

March 5, 2020

Conditions

Pain, PostoperativeCatheter BlockageAnesthesia

Keywords

infraclavicular catheterupper extremity surgeryPostoperative analgesiacontinuous nerve blockCatheter tips configurations

Outcome Measures

Primary Outcomes (5)

  • numeric rating scale (NRS)

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

    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

  • 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

Study Arms (2)

CEMP (closed-ended multiport catheter) group

ACTIVE COMPARATOR

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) groupProcedure: Patient-controlled analgesia

OESP (open-ended single port catheter) group

ACTIVE COMPARATOR

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) groupProcedure: Patient-controlled analgesia

Interventions

CEMP (closed-ended multiport catheter) groupPROCEDURE

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.

CEMP (closed-ended multiport catheter) group
OESP (open-ended single port catheter) groupPROCEDURE

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.

OESP (open-ended single port catheter) group
Patient-controlled analgesiaPROCEDURE

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.

CEMP (closed-ended multiport catheter) groupOESP (open-ended single port catheter) group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, Keçiören, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Population GroupsAnalgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsAnalgesiaAnesthesia and Analgesia

Study Officials

  • Mehmet B EŞKİN, M.D.

    Gulhane Training and Research Hospital

    STUDY DIRECTOR

  • Ayşegül Ceylan

    Gulhane Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 19, 2019

Study Start

December 10, 2019

Primary Completion

February 12, 2020

Study Completion

February 28, 2020

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

TU(1)