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Completed

NCT Number: NCT02270255

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

McGill University Health Centre - Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Superior hypogastric nerve block

Procedure

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% Ropivacaine

Drug

20 ml of 0.75% Ropivacaine

Other names: Naropin

Subcutaneous injection

Procedure

Injection into subcutaneous tissues in periumbilical region

1% Xylocaine

Drug

5ml of 1% Xylocaine

Other names: Lidocaine

Primary outcomes

  1. 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)

    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)

Secondary outcomes

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

    Time frame: 10 days

    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.

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2014
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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