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LeiomyomaPhase 2NCT02270255

Superior Hypogastric Nerve Block for Pain Control Post-uterine Fibroid Embolization

A Phase 2 study testing Superior hypogastric nerve block, 0.75% Ropivacaine and Subcutaneous injection in people with Leiomyoma, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Uterine fibroid embolization (UFE) is now an accepted treatment of uterine fibroids. However the procedure is often very painful and, in many centres, patients are admitted overnight with patient controlled analgesic (PCA) pumps for pain control and discharged the next day with heavy pain medications. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Leiomyoma
What is being tested?
Superior hypogastric nerve block, 0.75% Ropivacaine and Subcutaneous injection
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteCanada
Study dates
Apr 2015to 1 Nov 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • All women with symptomatic fibroids or adenomyosis that have requested and been approved for uterine artery embolization
  • Ability to comply with the requirements of the study procedures

Who cannot join

  • Patients in whom the vascular anatomy prevents access to the superior hypogastric nerve plexus safely
  • Patients who have known allergy to the anesthetic agent
  • Patients with signs of skin infection at the entry site of the needle used to place the nerve block
  • Patients with signs of infection such as fever
  • Patients with history of inflammatory bowel disease of with signs of colitis
  • Patients with uncorrectable abnormal coagulation status (INR >1.5 and plt < 50000 without use of anticoagulation agents)
Show all 9Show fewer
  • Patients with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
  • Patients who are uncooperative, cannot follow instructions, or who are unlikely to comply with follow-up appointments or fill-out the post-procedural pain questionnaires.
  • Patients with a mental state that may preclude completion of the study procedure or is unable to provide informed consent

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University Health Centre - Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

Other trials in Canada

About this study

Official title: Prospective Blinded Study Looking at PO/IV Analgesia Alone Versus PO/IV Analgesia With Superior Hypogastric Nerve Block for Uterine Artery Embolization Pain Management

Uterine fibroid embolization (UFE) is now an accepted treatment of uterine fibroids. However the procedure is often very painful and, in many centres, patients are admitted overnight with patient controlled analgesic (PCA) pumps for pain control and discharged the next day with heavy pain medications. The goal of this study is to evaluate the effectiveness of a superior hypogastric nerve block (SHGNB) in controlling the pain post-UFE.

Read the detailed description

This is a double blinded study in which the patients and the primary operators of the UFE as well as the post-procedural caregivers are blinded to whether the patients have received a sham procedure (injection of xylocaine in the skin in the peri-umbilical region) or the superior hypogastric nerve block.

The superior hypogastric nerve block (SHGNB) consists of advancing a 21g Chiba needle via an anterior approach up to the superior hypogastric nerve plexus and injecting 20cc of 0.75% Ropivacaine which is a long lasting local anesthetic agent. The nerve plexus is positioned below the aortic bifurcation along the anterior surface of the vertebral body. By fluoroscopy, the location can be identified by having a catheter crossing the aortic bifurcation. That way, we are able to target, under fluoroscopy, the anterior surface of the vertebral body just below the catheter.

Our UFE starts with a right common femoral artery (CFA) access. The catheter is crossed to the left side and the left uterine artery embolized with polyvinyl alcohol (PVA) 500-700 particles. The operator will then leave the room. Another operator will come and perform either the hypogastric nerve block or the sham procedure (injection of xylocaine in the periumbilical subcutaneous tissues). If the hypogastric nerve block is done, the needle is advanced into position via an anterior periumbilical approach under fluoroscopic guidance. Once the bony surface is contacted, 3 cc of xylocaine is injected to numb the area and then 3-6 cc of contrast is injected to ensure that it drapes the anterior vertebral body surface. If it spreads along both sides of the vertebral body and there is no vascular intravasation of contrast, the 20 cc of Ropivacaine is injected. If it only drapes one side, 10 cc is injected and the needle repositioned to the other side, the position verified with contrast, and the left over 10 cc of Ropivacaine injected.

After the block or sham procedure is done, the primary operator enters the room again and the UFE completed with embolization of the right uterine artery.

The patient is transferred to the recovery room and monitored. Pain medication including fentanyl and midazolam are offered at routine interval or on patient request. Pain scales are measured routinely and the patient is discharge home with a pain survey with visual analog pain scales to be performed routinely for 10 days.

The patient is followed up in 4-6 months with a follow-up magnetic resonance imaging (MRI) and consultation to look at the results of the procedure.

Comparison of the pain scale reports and use of pain medication will be evaluated between both groups to determine if there is a statistically significant difference.

Conditions
Leiomyoma
Being tested
Superior hypogastric nerve block, 0.75% Ropivacaine, Subcutaneous injection, 1% Xylocaine
Keywords
embolization, analgesia
Medical subject headings
Leiomyoma, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Superior hypogastric nerve blockProcedure or surgery

    21g Chiba needle advanced into the superior hypogastric plexus via an anterior infraumbilical approach using the arterial catheter as a fluoroscopic landmark to target the vertebral body below.

  • 0.75% RopivacaineDrug

    Also called Naropin

    20 ml of 0.75% Ropivacaine

  • Subcutaneous injectionProcedure or surgery

    Injection into subcutaneous tissues in periumbilical region

  • 1% XylocaineDrug

    Also called Lidocaine

    5ml of 1% Xylocaine

Study groups in NCT02270255
Study groupRoleWhat they receive
Control groupSham comparatorSham procedure. Subcutaneous injection of 5cc of 1% Xylocaine in the periumbilical region.
Receives: Procedure: Subcutaneous injection; Drug: 1% Xylocaine
Sup Hypogastric Nerve block groupExperimentalSuperior hypogastric nerve block performed during UFE. 20cc of 0.75% Ropivacaine injected at the superior hypogastric nerve plexus.
Receives: Procedure: Superior hypogastric nerve block; Drug: 0.75% Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mg Equivalent Morphine Used Until Discharge From Recovery Room to Control Pain Level Below 4/10 (VAS)

    mg equivalent morphine used until discharge from recovery room to maintain pain level below 4/10 (visual analog scale 0/10=no pain to 10/10=worse pain the patient could imagine)

    Measured: 6 hrs (from time of end of UFE to time of discharge from recovery room)

Secondary outcomes (1)

  1. Number of Patients With Serious Adverse Reactions From Superior Hypogastric Nerve Block

    Number of patients with Grade C/D/E/F adverse events (Society of Interventional Radiology (SIR) Classification). Per Society of Interventional Radiology (SIR) Classification: Grade C, require therapy, brief hospitalization (<48 hours); Grade D, require major therapy, unplanned increased level of care, prolonged hospitalization (>48 hours); Grade E, permanent adverse sequelae; Grade F, death.

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2014 (estimated)
  2. Study startApr 2015
  3. Primary completion1 Nov 2017
  4. Study completion1 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02270255
Sponsor's protocol ID
4242
Status last verified
Aug 2019
First submitted
16 Oct 2014
Last updated
14 Aug 2019
Data monitoring committee
No
Individual data sharing
No

Publications

  • Rasuli P, Jolly EE, Hammond I, French GJ, Preston R, Goulet S, Hamilton L, Tabib M. Superior hypogastric nerve block for pain control in outpatient uterine artery embolization. J Vasc Interv Radiol. 2004 Dec;15(12):1423-9. doi: 10.1097/01.RVI.0000137406.09852.A4.

    PubMed 15590800

  • Yoon J, Valenti D, Muchantef K, Cabrera T, Toonsi F, Torres C, Bessissow A, Bandegi P, Boucher LM. Superior Hypogastric Nerve Block as Post-Uterine Artery Embolization Analgesia: A Randomized and Double-Blind Clinical Trial. Radiology. 2018 Oct;289(1):248-254. doi: 10.1148/radiol.2018172714. Epub 2018 Jul 10.

    PubMed 29989515

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Superior hypogastric nerve block, 0.75% Ropivacaine and Subcutaneous injection in people with Leiomyoma, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mg Equivalent Morphine Used Until Discharge From Recovery Room to Control Pain Level Below 4/10 (VAS) (time frame: 6 hrs (from time of end of UFE to time of discharge from recovery room)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02270255, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.

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