Effects of Quadratus Lumborum Block on Lower Urinary System Symptoms

NCT06290323 | Completed

• 1 other identifier: 11/05/2022-9/VIII
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

Lithotripsy; Lower Urinary Tract Symptoms; Pain

Outcome Measures

Primary Outcomes (1)

• Quadratus posterior block

  On the 7th post-operative day, lower urinary tract symptoms due to the ureteral stent will be evaluated with the ureteral stent symptom scoring questionnaire (with the stent in place) (questionnaire 1). Approximately one month after their operations, patients' lower urinary tract symptoms will be questioned withent symptom scoring survey (after stent removal) (survey 2) (Appendix 2) five the ureteral st days after their ureteral stents are removed.

  1 month

Secondary Outcomes (1)

• Pain Score

  7 days

Study Arms (2)

Placebo

OTHER

Patients in the first group are the control group, and after spinal anesthesia, the sensory block is formed, and the lithotomy position will be taken for the surgical procedure. Patients will be monitored for 48 hours for postoperative pain (Numarating Raiting Scala: NRS) and side effects. On the postoperative 7th day, the patient's pain level will be NRS, and the DJS-connected sub-urinary system symptoms assessed will be evaluated with the ureteral stent discomfort questionnaire (with the stent inserted). In our clinic, approximately one month after URS operations, 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 discomfort questionnaire (after removal of the stent).

Procedure: Placebo

Quadratus lumborum

ACTIVE COMPARATOR

After the posterior quadratus lumborum block was made in the lateral decubitus position, the patient was taken to the lithotomy position for surgery. Patients will be monitored for 48 hours for postoperative pain (Numarating Raiting Scala: NRS) and side effects. On the postoperative 7th day, the patient's pain level will be NRS and the DJS-connected sub-urinary system symptoms will be assessed and evaluated using the ureteral stent discomfort questionnaire (with the stent inserted). 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 discomfort questionnaire (after removal of the stent).

Procedure: Quadratus lumborum block

Interventions

Quadratus lumborum block PROCEDURE

Posterior quadratus lumborum block

Quadratus lumborum

Placebo PROCEDURE

Patients in the first group are the control group and after spinal anesthesia, the sensory block is formed, the lithotomy position will be taken for the surgical procedure.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral URS planned to be applied
• DJS is planned to be inserted due to unilateral stone size of 5-15 mm.
• ASA I-II-III patients

You may not qualify if:

• Patients with bilateral ureteral stones,
• Patients with \>15 mm or \<5 mm ureteral stones,
• Patients with known paracetamol allergy,
• Patients with any contraindications to the regional technique
• Patients with chronic analgesic use
• Patients with a body mass index over 35 kg/m2

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Mugla Sitki Kocman Training and Research Hospital

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Pain

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Eylem Yasar, MD

  Mugla Sitki Kocman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher evaluating the survey does not know which group the patients are.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients with double J catheter inserted into ureteroscopic lithotripsy surgeries due to urethral stones

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 4, 2024
• Study Start: January 25, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 4, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)