NCT05022160

Brief Summary

Bladder irrigation with a 3 way foley catheter is an important component of post operative management of transurethral bladder surgeries. But it is associated with a high incidence of bladder discomfort. Catheter related bladder discomfort (CRBD) doesn't respond to the orthodox opioid pain medication and is greatly distressful to the patients postoperatively, adversely affecting the quality of recovery often requiring administration of additional pain medication thereby increasing treatment costs, patient dissatisfaction and longer hospital stays. Several systemic agents have been used to reduce CRBD, but they have many side effects. A trial has been planned to find a way of reducing CRBD avoid distressing systemic side effects

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
250

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2021

Shorter than P25 for early_phase_1

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

Study Start

First participant enrolled

August 10, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

August 16, 2021

Last Update Submit

August 21, 2021

Conditions

Bladder NeoplasmProstatic Neoplasms

Keywords

Bupivacainepudendal nerve blockCRBD

Outcome Measures

Primary Outcomes (1)

  • Catheter related bladder discomfort

    Frequency of catheter related bladder discomfort at 3,8,12 and 24 hours after surgery

    24 hours post surgery

Secondary Outcomes (1)

  • average intensity of Catheter related bladder discomfort

    24 hours post surgery

Study Arms (2)

Group P

EXPERIMENTAL

Patients in this group will receive bilateral pudendal nerve block after spinal anesthesia- before starting the surgery

Drug: pudendal nerve block

Group C

PLACEBO COMPARATOR

Patients in this group will only receive spinal anesthesia before starting the surgery

Drug: pudendal nerve block

Interventions

pudendal nerve blockDRUG

All patients in the study group will receive bilateral pudendal nerve block at the end of surgery, with help of landmark technique, using 0.5% bupivacaine

Group CGroup P

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male patients.
  • Age \>18 years
  • Patients undergoing TURP \& TURBT under spinal anesthesia
  • No history of chronic pain
  • ASA I, II \& III

You may not qualify if:

  • Female gender
  • Ischemic Heart Disease
  • Chronic Obstructive Pulmonary Disease
  • Coagulopathy
  • Mental Disorder
  • ASA IV \& V
  • Conversion of spinal anesthesia to general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Madiha Ahmed

Islamabad, 45710, Pakistan

RECRUITING

Related Publications (2)

  • Patel HD, Ball MW, Cohen JE, Kates M, Pierorazio PM, Allaf ME. Morbidity of urologic surgical procedures: an analysis of rates, risk factors, and outcomes. Urology. 2015 Mar;85(3):552-9. doi: 10.1016/j.urology.2014.11.034.

    PMID: 25733265BACKGROUND

  • Xiaoqiang L, Xuerong Z, Juan L, Mathew BS, Xiaorong Y, Qin W, Lili L, Yingying Z, Jun L. Efficacy of pudendal nerve block for alleviation of catheter-related bladder discomfort in male patients undergoing lower urinary tract surgeries: A randomized, controlled, double-blind trial. Medicine (Baltimore). 2017 Dec;96(49):e8932. doi: 10.1097/MD.0000000000008932.

    PMID: 29245259BACKGROUND

MeSH Terms

Conditions

Urinary Bladder NeoplasmsProstatic Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 26, 2021

Study Start

August 10, 2021

Primary Completion

November 10, 2021

Study Completion

November 10, 2021

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)