Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290323
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-02-12
Brief Title:
Effects of Quadratus Lumborum Block on Lower Urinary System Symptoms
Sponsor:
Muğla Sıtkı Koçman University
Organization:
Muğla Sıtkı Koçman University
Study Overview
Official Title:
Effects of Postoperative Quadratus Lumborum Block on Sub-Urine System Symptoms in Ureteroscopic Lithotripsy Operations Randomized Controlled Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The most common reason for applying to a hospital in the postoperative period is due to the double J stent inserted during operations of the ureteroscopic lithotripsy which is reflected pain T11-L2 The posterior approximation QL block QL-P extends more quickly to the thoracic paravertebral cavity or thoracolumbar plane creating analgesia from T 7 to L 1 The effects of double J catheter in patients are followed by the Ureteral Stent Symptom Scoring Survey QL-P for postoperative analgesia after URS operations Our primary hypothesis in this prospective randomized controlled study is that the symptoms of the sub-urinary system associated with the DJS of the QL-P block will decrease Our secondary hypotheses in the study are to investigate the effects of the unilateral QL-P block made under ultrasound guidance on pain scores after ureteroscopic lithotripsy operations due to unilateral ureteral stones made under spinal anesthesia
Detailed Description:
All patients will be seated to apply spinal anesthetic Patients will be inserted into the interspinal space using a 25-gauge Quincke needle from the lumbar L 3-L4 spinal interval or the L4-L5 spinal interval thereby inducing a sensory block at a 05 hyperbaric bupivacaine level with a Trocal T 10 Once a T-10 level sensory block has been established the patients will be separated into two groups As the control group the individuals comprising Group 1 will be positioned in the lithotomy position after the sensory block for the surgical procedure Group 2 patients will be placed in lateral decubitus to conduct a quadratus lumborum block Once the skins surface has been sterilized the convex ultrasound probe SonoSiteMTurbo FUJIFILM SonoSite Bothell WA will be moved laterally to the lateral to visualize the psoas and quadratus lumborum muscles The probe will be inserted perpendicular to the spine in the 12th vertebral body The in-plane method with the lateral of the probe 22 gauge needle between the quadratus lumborum muscle and the front layer of the thoracolumbar fascia after the position accuracy is determined with 1-2 mL serum physiologic 0375 Mg of bupivacaine will be injected in 20 ml The patient will then be placed in the lithotomy position for the surgical procedure Patients of a blind research assistant to the group distribution are seen on-site in the 1st 6th 12th and 24th hours after surgery postoperative 7 Per phone daily pain intensities will be assessed by a numerical assessment scale Numeric Rating Scala NRS If NRS is above 3 for half an hour 100 mg tramadol will be added For 48 hours tramadol and non-steroidal anti-inflammatory consumption will be monitored In addition complications such as local anesthesia toxicity allergy internal organ injury postoperative nausea and vomiting and postoperative bleeding will be recorded In addition on the 7th post-operative day the patients pain level will be evaluated with NRS and the sub-productive system symptoms connected to DJS are assessed with the ureteral stent symptom scoring questionnaire while inserted in the stent In our clinic approximately one month after URS operations a control cystoscopy is performed and ureteral stents are removed After five days of removal of the ureteral stent the lower urinary system symptoms will be questioned with the ureteral stent symptom scoring questionnaire after the stent is removed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None