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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator | Sham procedure. Subcutaneous injection of 5cc of 1% Xylocaine in the periumbilical region. |
|
| Sup Hypogastric Nerve block group | Experimental | Superior hypogastric nerve block performed during UFE. 20cc of 0.75% Ropivacaine injected at the superior hypogastric nerve plexus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 hrs (from time of end of UFE to time of discharge from recovery room) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis-Martin NJ Boucher, MD/PhD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre - Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15590800 | Background | 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. | |
| 29989515 | Derived | 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. |
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No enrolled participants were excluded from the study. Data were complete for all participants up to the time of discharge from the postanesthesia care unit (PACU). Forty-three of the 44 participants (98%) completed the home survey; one participant (2%) was lost to follow-up.
Between April 2015 and February 2017, 87 patients were approached for enrollment. All patients fit the inclusion criteria, and no patients were excluded. However, 43 of the 87 patients (49%) declined participation in the study, leaving 44 patients (51%) who agreed to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Sham procedure. Subcutaneous injection of 5cc of 1% Xylocaine in the periumbilical region. Subcutaneous injection: Injection into subcutaneous tissues in periumbilical region 1% Xylocaine: 5ml of 1% Xylocaine |
| FG001 | Sup Hypogastric Nerve Block Group | Superior hypogastric nerve block performed during UFE. 20cc of 0.75% Ropivacaine injected at the superior hypogastric nerve plexus. Superior hypogastric nerve block: 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: 20 ml of 0.75% Ropivacaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Same as assignment population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Sham procedure. Subcutaneous injection of 5cc of 1% Xylocaine in the periumbilical region. Subcutaneous injection: Injection into subcutaneous tissues in periumbilical region 1% Xylocaine: 5ml of 1% Xylocaine |
| BG001 | Sup Hypogastric Nerve Block Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | mg | 6 hrs (from time of end of UFE to time of discharge from recovery room) |
|
4-6 months
SIR Classification definition of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Sham procedure. Subcutaneous injection of 5cc of 1% Xylocaine in the periumbilical region. Subcutaneous injection: Injection into subcutaneous tissues in periumbilical region 1% Xylocaine: 5ml of 1% Xylocaine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain during the block procedure itself | Nervous system disorders | Systematic Assessment | Temporary discomfort/pain during placement of the block needle. |
Small number of patients. Single centre study. Occasional use of different narcotics needing morphine equivalent calculations. SHAM procedure did not place a needle as deep as in the study group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Louis-Martin boucher | McGill University Health Centre | 5149341934 | 44454 | lmboucher@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 2, 2014 | Mar 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D007279 | Injections, Subcutaneous |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| 0.75% Ropivacaine | Drug | 20 ml of 0.75% Ropivacaine |
|
|
| Subcutaneous injection | Procedure | Injection into subcutaneous tissues in periumbilical region |
|
| 1% Xylocaine | Drug | 5ml of 1% Xylocaine |
|
|
| 10 days |
Superior hypogastric nerve block performed during UFE. 20cc of 0.75% Ropivacaine injected at the superior hypogastric nerve plexus. Superior hypogastric nerve block: 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: 20 ml of 0.75% Ropivacaine |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | McGill University Health Centre | Number | participants |
|
| Pain sensitivity | Person self-evaluation of pain of vaccine on scale of 0-10/10 Visual analog scale (VAS). Patient rates pain on a scale from 0 to 10, 0 being no pain at all and 10 being the worse pain they could ever imagine. | Mean | Standard Deviation | units on a scale |
|
| Pain of regular menstrual cramps | Patients self-reporting of pain of average menstrual cramp on a scale form 0 to 10 (Visual analog scale - VAS), 0 being no pain at all and 10 being the worse pain they could ever imagine. | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 10 days |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Sup Hypogastric Nerve Block Group | Superior hypogastric nerve block performed during UFE. 20cc of 0.75% Ropivacaine injected at the superior hypogastric nerve plexus. Superior hypogastric nerve block: 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: 20 ml of 0.75% Ropivacaine | 0 | 22 | 0 | 22 | 11 | 22 |
|
| Hard fibroid needing use of 18g needle | Reproductive system and breast disorders | Systematic Assessment |
|
| Tachycardia, transient, from Xylocaine with epi injection | Cardiac disorders | Systematic Assessment | To ensure no intravascular injection of long-acting block agent, a test dose of Xylocaine with epi is injected. One patient had a transient tachycardia confirming intravascular uptake and needing change in needle position. |
|
| Aspiration of blood | Vascular disorders | Systematic Assessment | Aspiration of blood prior to injecting anesthetic, needing needle repositioning. |
|
| Temporary heat sensation in foot | Nervous system disorders | Systematic Assessment | Presumably from sympathetic chain blockade |
|
| Temporary heaviness in foot | Nervous system disorders | Systematic Assessment | Resolved by the end of the time in the PACU |
|
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| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000083 | Acetanilides |