Comparison of Open-tip End-hole and Close-tip Triple-hole Catheters For Continuous Infraclavicular Analgesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- numeric rating scale (NRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
CEMP (closed-ended multiport catheter) group
Infraclavicular closed-ended multiport nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia
Intervention: CEMP (closed-ended multiport catheter) group (Procedure)
CEMP (closed-ended multiport catheter) group
Infraclavicular closed-ended multiport nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia
Intervention: Patient-controlled analgesia (Procedure)
OESP (open-ended single port catheter) group
Infraclavicular open-ended single port nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia
Intervention: OESP (open-ended single port catheter) group (Procedure)
OESP (open-ended single port catheter) group
Infraclavicular open-ended single port nerve catheter will be included in the patients undergoing upper extremity surgery for postoperative analgesia
Intervention: Patient-controlled analgesia (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mehmet Burak Eşkin
Assistant Professor
Gulhane School of Medicine