Comparison of Catheters Orifice Configuration For Continuous Infraclavicular Analgesia
Primary Purpose
Pain, Postoperative, Catheter Blockage, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
CEMP (closed-ended multiport catheter) group
OESP (open-ended single port catheter) group
Patient-controlled analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring infraclavicular catheter, upper extremity surgery, Postoperative analgesia, continuous nerve block, Catheter tips configurations
Eligibility Criteria
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.
Sites / Locations
- Gulhane Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CEMP (closed-ended multiport catheter) group
OESP (open-ended single port catheter) group
Arm Description
Infraclavicular closed-ended multiport nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia
Infraclavicular open-ended single port nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia
Outcomes
Primary Outcome Measures
numeric rating scale (NRS)
Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)
data from patient-controlled analgesia (PCA) device
The number of PCA button presses
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.
complications related to opioids
Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration,
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04205695
First Posted
December 16, 2019
Last Updated
March 5, 2020
Sponsor
Gulhane School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04205695
Brief Title
Comparison of Catheters Orifice Configuration For Continuous Infraclavicular Analgesia
Official Title
Comparison of Open-tip End-hole and Close-tip Triple-hole Catheters For Continuous Infraclavicular Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Catheter Blockage, Anesthesia
Keywords
infraclavicular catheter, upper extremity surgery, Postoperative analgesia, continuous nerve block, Catheter tips configurations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CEMP (closed-ended multiport catheter) group
Arm Type
Active Comparator
Arm Description
Infraclavicular closed-ended multiport nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia
Arm Title
OESP (open-ended single port catheter) group
Arm Type
Active Comparator
Arm Description
Infraclavicular open-ended single port nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
CEMP (closed-ended multiport catheter) group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
OESP (open-ended single port catheter) group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Patient-controlled analgesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
numeric rating scale (NRS)
Description
Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)
Time Frame
three days postoperatively
Title
data from patient-controlled analgesia (PCA) device
Description
The number of PCA button presses
Time Frame
three days postoperatively
Title
Data from patient-controlled analgesia (PCA) device
Description
Total amount (ml) of local anesthetic (0.125% bupivacaine) delivered to patient recorded by patient controlled analgesia device.
Time Frame
three days postoperatively
Title
complications related to opioids
Description
Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration,
Time Frame
three days postoperatively
Title
the requirement for additional analgesia
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet B EŞKİN, M.D.
Organizational Affiliation
Gulhane Training and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ayşegül Ceylan
Organizational Affiliation
Gulhane Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulhane Training and Research Hospital
City
Ankara
State/Province
Keçiören
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
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Comparison of Catheters Orifice Configuration For Continuous Infraclavicular Analgesia
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