Anesthesia Clinical Trial
Official title:
Comparison of Open-tip End-hole and Close-tip Triple-hole Catheters For Continuous Infraclavicular Analgesia
Verified date | March 2020 |
Source | Gulhane School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Gulhane Training and Research Hospital | Ankara | Keçiören |
Lead Sponsor | Collaborator |
---|---|
Gulhane School of Medicine |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | numeric rating scale (NRS) | Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS) | three days postoperatively | |
Primary | data from patient-controlled analgesia (PCA) device | The number of PCA button presses | three days postoperatively | |
Primary | 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 | |
Primary | complications related to opioids | Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration, | three days postoperatively | |
Primary | 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 |
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