Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block

Sponsor

Diskapi Teaching and Research Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05540847

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

20.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aimed to assess the effectiveness of the ultrasound-guided interfascial injection approach with the subpectineal injection technique for obturator nerve block in bladder cancers undergoing transurethral resection of bladder tumor (TURBT) under spinal anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Bladder Neoplasm	Procedure: Interfascial Injection Procedure: Subpectineal Injection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block

Anticipated Study Start Date :

Sep 20, 2022

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Dec 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ultrasound guided interfascial obturator nerve block In supine position, ultrasound probe will be placed on inguinal region, 2-3 cm below to the inguinal crease. Patients in this group will receive interfascial obturator nerve block under ultrasound guidance.	Procedure: Interfascial Injection Interfascial Injection on Ultrasound-guided Obturator Nerve Block
Experimental: Ultrasound guided subpectineal obturator nerve block In supine position, the ultrasound probe will be placed on in inguinal region, 1-2 cm below to the inguinal crease to identiy the subpectineal area. Patients in this group will receive subpectineal obturator nerve block under ultrasound guidance.	Procedure: Subpectineal Injection Subpectineal Injection on Ultrasound-guided Obturator Nerve Block

Arm

Intervention/Treatment

Active Comparator: Ultrasound guided interfascial obturator nerve block

In supine position, ultrasound probe will be placed on inguinal region, 2-3 cm below to the inguinal crease. Patients in this group will receive interfascial obturator nerve block under ultrasound guidance.

Procedure: Interfascial Injection

Interfascial Injection on Ultrasound-guided Obturator Nerve Block

Experimental: Ultrasound guided subpectineal obturator nerve block

In supine position, the ultrasound probe will be placed on in inguinal region, 1-2 cm below to the inguinal crease to identiy the subpectineal area. Patients in this group will receive subpectineal obturator nerve block under ultrasound guidance.

Procedure: Subpectineal Injection

Subpectineal Injection on Ultrasound-guided Obturator Nerve Block

Outcome Measures

Primary Outcome Measures

Success rate of obturatr nerve block [Peroperative period]
The success or fail of the obturator nerve block will be conformed using nerve stimulator. Detecting muscles twitch will br considered to be a fail.

Secondary Outcome Measures

Number of adductor muscle spazms [Intraoperative period]
Number of adductor muscle spazms in each group will be noted during the intraoperative period.
Sensory block [30 minutes after the intervention]
Sensory block area will be evaluated by a pin prick at in the dermatomal areas related obturator nerve and branches.
Patient satisfaction [Peroperative period]
Changes in overall satisfaction will be assessed using a 5 point Likert Scale ( 1-very dissatisfied, 2- dissatisfied, 3- neutral, 4-satisfied, 5 - very satisfied
Procedure time [During the procedure]
Block performance time will be recorded from the time the first ultrasound image is obtained until the procedure is completed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Lateral wall bladder tumour
ASA I-II patients

Exclusion Criteria:

Contraindications for spinal anesthesia,
Tumors that disrupt the integrity of the bladder,
Coagulation disorders,
Uncooperative patients,
Allergy to local anesthetics.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital	Yenimahalle	Ankara	Turkey	06170

Sponsors and Collaborators

Diskapi Teaching and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Halil Cihan Kose, Principal investigator, Diskapi Teaching and Research Hospital

ClinicalTrials.gov Identifier:

NCT05540847

Other Study ID Numbers:

141/09

First Posted:

Sep 15, 2022

Last Update Posted:

Sep 16, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Halil Cihan Kose, Principal investigator, Diskapi Teaching and Research Hospital

obturator nerve block

ultrasound guided block

bladder tumor

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Study Results

No Results Posted as of Sep 16, 2022