NCT04782206

Brief Summary

The investigators hypothesis that adding pulsed radiofrequency neuromodulation at S3 nerve root to superior hypogastric plexus chemical neurolysis improves analgesia in patients with chronic pelvic cancer pain.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

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

February 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

February 26, 2021

Last Update Submit

March 3, 2021

Conditions

Pain CancerPain, Chronic

Keywords

pelvic cancer painsuperior hypogastric plexus blockpulsed radiofrequency

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    Visual Analogue Scale post-procedure

    from 30 min. after procedure to 2 months after it

Secondary Outcomes (3)

  • complications

    during the block procedure and within the first 24 hours after the block

  • procedure time

    during the block procedure

  • Total oral analgesic consumption

    in the first 24 hours after procedures and at 1,2,4 weeks and 2 months visits after it

Study Arms (2)

group 1

ACTIVE COMPARATOR

superior hypogastric plexus block

Procedure: superior hypogastric plexus block

group 2

ACTIVE COMPARATOR

pulsed radiofrequency at S3 nerve root + superior hypogastric plexus block

Procedure: pulsed radiofrequency at S3 root plus superior hypogastric plexus block

Interventions

superior hypogastric plexus blockPROCEDURE

superior hypogastric plexus chemical neurolysis

group 1
pulsed radiofrequency at S3 root plus superior hypogastric plexus blockPROCEDURE

pulsed radiofrequency neuromodulation at S3 root plus superior hypogastric plexus chemical neurolysis

group 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pelvic cancer patients
  • with pelvic pain not responding to oral analgesic medications
  • side effects of oral analgesic medications

You may not qualify if:

  • patients with metastatic cancer disease
  • patients with significantly impaired organ functions
  • patients with bleeding diathesis
  • patients with mental disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cancer PainChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double-blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor of Anesthesia, ICU, and Pain management

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 4, 2021

Study Start

March 15, 2021

Primary Completion

March 15, 2022

Study Completion

May 1, 2022

Last Updated

March 4, 2021

Record last verified: 2021-03