Obturator Block in Lateral Tumors of the Bladder: Does it Have Adverse Effects on Early Postoperative Mobilization?

Investigation of delay in postoperative mobilization due to motor block and complications related to block in patients who underwent USG-assisted obturator nerve block with distal approach

Study Overview

• Status: Not yet recruiting
• Conditions: Obturator Nerve Block; Ultrasound Guided Nerve Block; Complications Neurological
• Intervention / Treatment: Procedure: spinal block and obturator nerve block

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: serap diker, MD; Phone Number: +9031256600; Email: serap.diker@gmail.com
• Study Contact Backup: Name: feryal akçay, MD; Phone Number: +9031256600; Email: feryalakcay@gmail.com

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey
      • Serap Diker
      • Contact: Serap Diker, MD; Email: serap.diker@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who will undergo transurethral resection of the bladder

Description

Inclusion Criteria:

• age between 18-75
• ASA1, ASA2, ASA 3 physical status

Exclusion Criteria:

1. The patient's refusal
2. Active infection in the area to be blocked
3. Kidney failure
4. Liver failure
5. Heart failure
6. BMI less than 18 and a BMI greater than 40

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
spinal anesthesia; spinal block will be performed to patients after monitoring	Procedure: spinal block and obturator nerve block; spinal block and obturator nerve block
spinal anesthesia and obturator nerve block; spinal block will be performed to patients after monitoring, and then the patients in the ONB block group will be given the appropriate position, with a USG-assisted distal approach, 5 cc %2 prilocain into the anterior and 5cc %2 prilocain into the posterior branch of the obturator nerve.	Procedure: spinal block and obturator nerve block; spinal block and obturator nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pin prick test	postoperatively sensation block	postoperatively 2nd hour
bromage score	motorial block	postoperatively 2nd hour
pin prick test	postoperatively sensation block	postoperatively 5th hour
bromage score	motorial block	postoperatively 5th hour

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: E2-22-1854

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No