Pain, PostoperativeNCT04205695
Comparison of Catheters Orifice Configuration For Continuous Infraclavicular Analgesia
A study testing CEMP (closed-ended multiport catheter) group and OESP (open-ended single port catheter) group in people with Pain, Postoperative and Catheter Blockage, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Postoperative, Catheter Blockage, Anesthesia
- What is being tested?
- CEMP (closed-ended multiport catheter) group and OESP (open-ended single port catheter) group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2019to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Score I-III
- upper extremity surgery
Who cannot join
- emergency surgery,
- secondary surgery,
- chronic pain treatment
- pregnancy,
- any contraindication to peripheral nerve blockade,
- pre-existing peripheral nerve neuropathy,
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, Keçiören, 06100
About this study
Official title: 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.
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.
- Conditions
- Pain, Postoperative, Catheter Blockage, Anesthesia
- Being tested
- CEMP (closed-ended multiport catheter) group, OESP (open-ended single port catheter) group, Patient-controlled analgesia
- Keywords
- infraclavicular catheter, upper extremity surgery, Postoperative analgesia, continuous nerve block, Catheter tips configurations
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEMP (closed-ended multiport catheter) groupProcedure or surgery
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) groupProcedure or surgery
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 analgesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: CEMP (closed-ended multiport catheter) group; Procedure: 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 Receives: Procedure: OESP (open-ended single port catheter) group; Procedure: Patient-controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric rating scale (NRS)
Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)
Measured: three days postoperatively
data from patient-controlled analgesia (PCA) device
The number of PCA button presses
Measured: 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.
Measured: three days postoperatively
complications related to opioids
Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration,
Measured: 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.
Measured: three days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start10 Dec 2019
- Primary completion12 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Burak Eşkin, Gulhane School of Medicine
- Investigators
- Mehmet B EŞKİN, M.D., Study director, Gulhane Training and Research HospitalAyşegül Ceylan, Principal investigator, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205695
- Sponsor's protocol ID
- 19/398
- Status last verified
- Mar 2020
- First submitted
- 16 Dec 2019
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Open-tip End-hole and Close-tip Triple-hole Catheters For Continuous Infraclavicular Analgesia
- ClinicalTrials.gov ID
- NCT04205695
- Acronym / sponsor ID
- 19/398
- Conditions
- Pain, Postoperative, Catheter Blockage, Anesthesia
- Keywords
- infraclavicular catheter, upper extremity surgery, Postoperative analgesia, continuous nerve block, Catheter tips configurations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| CEMP (closed-ended multiport catheter) group | Active comparator | Procedure: CEMP (closed-ended multiport catheter) group, Procedure: Patient-controlled analgesiaInfraclavicular closed-ended multiport nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia |
| OESP (open-ended single port catheter) group | Active comparator | Procedure: OESP (open-ended single port catheter) group, Procedure: Patient-controlled analgesiaInfraclavicular open-ended single port nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) Score I-III
- upper extremity surgery
Key exclusion criteria (16 listed)
- emergency surgery,
- secondary surgery,
- chronic pain treatment
- pregnancy,
- any contraindication to peripheral nerve blockade,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEMP (closed-ended multiport catheter) groupThe 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 or surgery | CEMP (closed-ended multiport catheter) group |
| OESP (open-ended single port catheter) groupThe 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. | Procedure or surgery | OESP (open-ended single port catheter) group |
| Patient-controlled analgesiaA 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 or surgery | CEMP (closed-ended multiport catheter) group, OESP (open-ended single port catheter) group |
Primary outcome
numeric rating scale (NRS)
Time frame: three days postoperatively
Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)
data from patient-controlled analgesia (PCA) device
Time frame: three days postoperatively
The number of PCA button presses
Data from patient-controlled analgesia (PCA) device
Time frame: three days postoperatively
Total amount (ml) of local anesthetic (0.125% bupivacaine) delivered to patient recorded by patient controlled analgesia device.
complications related to opioids
Time frame: three days postoperatively
Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration,
the requirement for additional analgesia
Time frame: three days postoperatively
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet B EŞKİN, M.D. study director
Gulhane Training and Research Hospital
Ayşegül Ceylan principal investigator
Gulhane Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEMP (closed-ended multiport catheter) group and OESP (open-ended single port catheter) group in people with Pain, Postoperative and Catheter Blockage, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numeric rating scale (NRS) (time frame: three days postoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.