NCT00742807

Brief Summary

Giving infiltration analgesia around the neck of the womb (= paracervical block, PCB) is frequently experienced as a painful procedure by women undergoing follicle aspiration. Two sedation protocols, where in the one protocol a low dose of alfentanil hydrochloride is already administered before the PCB, will be compared with each other and pain relief measured using the 'Visual Analogue Scale' and the 'Short-Form McGill Questionnaire'

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2008

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
withdrawn

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 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

6.8 years

First QC Date

August 27, 2008

Last Update Submit

November 13, 2023

Conditions

Pain

Keywords

sensationreliefduringsurgery

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    During and immediately after surgery

Study Arms (2)

1

EXPERIMENTAL

Administration of low dose of alfentanil hydrochloride before paracervical block

Drug: Low dose of alfentanil hydrochloride

2

ACTIVE COMPARATOR

Administration of alfentanil hydrochloride dose after paracervical block

Drug: Normal dose of alfentanil hydrochloride

Interventions

Low dose of alfentanil hydrochlorideDRUG

Administration of low dose alfentanil hydrochloride before paracervical block

1
Normal dose of alfentanil hydrochlorideDRUG

Normal dose of alfentanil hydrochloride is administered after paracervical block

2

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women and female infertility patients
  • Between 18 and 43 years of age

You may not qualify if:

  • Patients with a known allergy to alfentanil hydrochloride or comparable drugs (morphine, cocaine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Pain

Interventions

Alfentanil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Frank Dumortier, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2008

First Posted

August 28, 2008

Study Start

August 1, 2008

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

November 15, 2023

Record last verified: 2023-11

Locations

BE(1)