Trial Outcomes & Findings for Superior Hypogastric Nerve Block for Pain Control Post-uterine Fibroid Embolization (NCT NCT02270255)
NCT ID: NCT02270255
Last Updated: 2019-08-14
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
6 hrs (from time of end of UFE to time of discharge from recovery room)
Results posted on
2019-08-14
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
Complete Data at Discharge PACU
|
22
|
22
|
|
Overall Study
Complete Data From Home Survey
|
21
|
22
|
|
Overall Study
COMPLETED
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=22 Participants
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
|
Sup Hypogastric Nerve Block Group
n=22 Participants
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
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
44 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 5.2 • n=22 Participants
|
47 years
STANDARD_DEVIATION 5.7 • n=22 Participants
|
46.5 years
STANDARD_DEVIATION 5.5 • n=44 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
44 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
22 participants
n=22 Participants
|
22 participants
n=22 Participants
|
44 participants
n=44 Participants
|
|
Pain sensitivity
|
3.2 units on a scale
STANDARD_DEVIATION 2.2 • n=22 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 2.3 • n=22 Participants
|
3.35 units on a scale
STANDARD_DEVIATION 2.2 • n=44 Participants
|
|
Pain of regular menstrual cramps
|
6.3 units on a scale
STANDARD_DEVIATION 2.5 • n=22 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 1.7 • n=22 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 2.1 • n=44 Participants
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Control Group
n=22 Participants
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
|
Sup Hypogastric Nerve Block Group
n=22 Participants
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
|
|---|---|---|
|
mg Equivalent Morphine Used Until Discharge From Recovery Room to Control Pain Level Below 4/10 (VAS)
|
11 mg
Standard Deviation 9
|
5.1 mg
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 10 daysNumber 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.
Outcome measures
| Measure |
Control Group
n=22 Participants
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
|
Sup Hypogastric Nerve Block Group
n=22 Participants
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
|
|---|---|---|
|
Number of Patients With Serious Adverse Reactions From Superior Hypogastric Nerve Block
|
0 Participants
|
0 Participants
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sup Hypogastric Nerve Block Group
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Group
n=22 participants at risk
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
|
Sup Hypogastric Nerve Block Group
n=22 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Pain during the block procedure itself
|
0.00%
0/22 • 4-6 months
SIR Classification definition of adverse events.
|
27.3%
6/22 • 4-6 months
SIR Classification definition of adverse events.
|
|
Reproductive system and breast disorders
Hard fibroid needing use of 18g needle
|
0.00%
0/22 • 4-6 months
SIR Classification definition of adverse events.
|
4.5%
1/22 • 4-6 months
SIR Classification definition of adverse events.
|
|
Cardiac disorders
Tachycardia, transient, from Xylocaine with epi injection
|
0.00%
0/22 • 4-6 months
SIR Classification definition of adverse events.
|
4.5%
1/22 • 4-6 months
SIR Classification definition of adverse events.
|
|
Vascular disorders
Aspiration of blood
|
0.00%
0/22 • 4-6 months
SIR Classification definition of adverse events.
|
4.5%
1/22 • 4-6 months
SIR Classification definition of adverse events.
|
|
Nervous system disorders
Temporary heat sensation in foot
|
0.00%
0/22 • 4-6 months
SIR Classification definition of adverse events.
|
4.5%
1/22 • 4-6 months
SIR Classification definition of adverse events.
|
|
Nervous system disorders
Temporary heaviness in foot
|
0.00%
0/22 • 4-6 months
SIR Classification definition of adverse events.
|
4.5%
1/22 • 4-6 months
SIR Classification definition of adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place