NCT02733705

Brief Summary

Nowadays, TRUS biopsy become one of the most popular tests for diagnosis of prostate cancer. This procedure causes pain to the patients who does not received the sedative drugs or analgesic drugs. There are many ways to reduce pain and inconvenience for the patients, such as intravenous propofol, intravenous fentanyl etc. In Siriraj hospital, anesthesiologists usually give intravenous propofol with intravenous opioids but the visual analogue score after this procedure was average at 0.9-2.9. Furthermore, some systematic reviews have shown that there was no difference in pain score between periprostatic nerve block plus opioid and periprostatic nerve block only. So, this study is to find out whether opioids is need for TRUS biopsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

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

March 27, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

March 27, 2016

Last Update Submit

August 31, 2021

Conditions

Pain

Keywords

PainTRUS biopsy

Outcome Measures

Primary Outcomes (1)

  • Pain assess using Numeric rating scale (NRS) score

    20 minutes

Secondary Outcomes (2)

  • Number of participants with hypoxia defined as oxygen saturation <92%

    60 minutes

  • Number of participants with hypotension, defined as systolic blood pressure <90 mmHg

    60 minutes

Study Arms (2)

Control

PLACEBO COMPARATOR

normal saline IV plus propofol infusion

Other: ControlDrug: propofol

Fentanyl

ACTIVE COMPARATOR

0.5 mcg/kg ideal body weight IV plus propofol infusion

Drug: FentanylDrug: propofol

Interventions

ControlOTHER

normal saline IV

Control
FentanylDRUG

fentanyl 0.5 mcg/kg ideal BW

Fentanyl
propofolDRUG

propofol infusion

ControlFentanyl

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 year
  • Patient American society of anesthesiology physical status I-III.
  • Scheduled for Transrectal ultrasound-guided prostate biopsy
  • BMI equal to or less than 30 kg/cm2

You may not qualify if:

  • Known hypersensitivity to propofol or fentanyl
  • History of bleeding tendency
  • Known case of active anal or rectal disease
  • Unable to rate pain score
  • History of drug abuse
  • Chronic opioid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sirilak Suksompong

Bangkok, 10700, Thailand

Location

Related Publications (1)

  • Suksompong S, Limratana P, Saengsomsuan N, Wongsawang N, Chaikittisilpa N. Propofol with or without fentanyl for pain relief after transrectal ultrasound-guided prostate (TRUS-P) biopsy: a randomized controlled study. Braz J Anesthesiol. 2021 Jul-Aug;71(4):345-351. doi: 10.1016/j.bjane.2021.02.001. Epub 2021 Feb 3.

    PMID: 34229860DERIVED

MeSH Terms

Conditions

Pain

Interventions

FentanylPropofol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Sirilak Suksompong

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 27, 2016

First Posted

April 11, 2016

Study Start

January 1, 2017

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

TH(1)