Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-01-10 @ 12:24 AM
Study NCT ID:
NCT04205695
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2019-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Catheters Orifice Configuration For Continuous Infraclavicular Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}, {'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-05', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'numeric rating scale (NRS)', 'timeFrame': 'three days postoperatively', 'description': 'Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)'}, {'measure': 'data from patient-controlled analgesia (PCA) device', 'timeFrame': 'three days postoperatively', 'description': 'The number of PCA button presses'}, {'measure': 'Data from patient-controlled analgesia (PCA) device', 'timeFrame': 'three days postoperatively', 'description': 'Total amount (ml) of local anesthetic (0.125% bupivacaine) delivered to patient recorded by patient controlled analgesia device.'}, {'measure': 'complications related to opioids', 'timeFrame': 'three days postoperatively', 'description': 'Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration,'}, {'measure': 'the requirement for additional analgesia', 'timeFrame': 'three days postoperatively', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infraclavicular catheter', 'upper extremity surgery', 'Postoperative analgesia', 'continuous nerve block', 'Catheter tips configurations'], 'conditions': ['Pain, Postoperative', 'Catheter Blockage', 'Anesthesia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) Score I-III\n* upper extremity surgery\n\nExclusion Criteria:\n\n* emergency surgery,\n* secondary surgery,\n* chronic pain treatment\n* pregnancy,\n* any contraindication to peripheral nerve blockade,\n* pre-existing peripheral nerve neuropathy,\n* allergy to local anesthetics (study medications),\n* ASA score ≥ 4,\n* neurologic or neuromuscular disease,\n* psychiatric disease,\n* renal failure,\n* hepatic failure,\n* NSAID contraindication,\n* inability to use a patient controlled analgesia (PCA) device,\n* infection at the injection site\n* withdrawal of consent.'}, 'identificationModule': {'nctId': 'NCT04205695', 'briefTitle': 'Comparison of Catheters Orifice Configuration For Continuous Infraclavicular Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Gulhane School of Medicine'}, 'officialTitle': 'Comparison of Open-tip End-hole and Close-tip Triple-hole Catheters For Continuous Infraclavicular Analgesia', 'orgStudyIdInfo': {'id': '19/398'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CEMP (closed-ended multiport catheter) group', 'description': 'Infraclavicular closed-ended multiport nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia', 'interventionNames': ['Procedure: CEMP (closed-ended multiport catheter) group', 'Procedure: Patient-controlled analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OESP (open-ended single port catheter) group', 'description': 'Infraclavicular open-ended single port nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia', 'interventionNames': ['Procedure: OESP (open-ended single port catheter) group', 'Procedure: Patient-controlled analgesia']}], 'interventions': [{'name': 'CEMP (closed-ended multiport catheter) group', 'type': 'PROCEDURE', '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.", 'armGroupLabels': ['CEMP (closed-ended multiport catheter) group']}, {'name': 'OESP (open-ended single port catheter) group', 'type': 'PROCEDURE', '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.", 'armGroupLabels': ['OESP (open-ended single port catheter) group']}, {'name': 'Patient-controlled analgesia', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['CEMP (closed-ended multiport catheter) group', 'OESP (open-ended single port catheter) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'state': 'Keçiören', 'country': 'Turkey (Türkiye)', 'facility': 'Gulhane Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Mehmet B EŞKİN, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gulhane Training and Research Hospital'}, {'name': 'Ayşegül Ceylan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gulhane Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mehmet Burak Eşkin', 'investigatorAffiliation': 'Gulhane School of Medicine'}}}}