NCT05652309

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

December 6, 2022

Last Update Submit

December 6, 2022

Conditions

Obturator Nerve BlockUltrasound Guided Nerve BlockComplications Neurological

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

spinal anesthesia

spinal block will be performed to patients after monitoring

Procedure: 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

Interventions

spinal block and obturator nerve blockPROCEDURE

spinal block and obturator nerve block

spinal anesthesiaspinal anesthesia and obturator nerve block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who will undergo transurethral resection of the bladder

You may qualify if:

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

You may not qualify if:

  • The patient's refusal
  • Active infection in the area to be blocked
  • Kidney failure
  • Liver failure
  • Heart failure
  • BMI less than 18 and a BMI greater than 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Serap Diker

Ankara, Çankaya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Central Study Contacts

serap diker, MD

CONTACT

+9031256600serap.diker@gmail.com

feryal akçay, MD

CONTACT

+9031256600feryalakcay@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 15, 2022

Study Start

January 1, 2023

Primary Completion

May 1, 2023

Study Completion

December 1, 2023

Last Updated

December 15, 2022

Record last verified: 2022-12

Locations

TU(1)