Trial Outcomes & Findings for Greater Occipital Nerve Block Versus Metoclopramide (NCT NCT03269435)
NCT ID: NCT03269435
Last Updated: 2021-09-22
Results Overview
Pain score assessed at baseline and one hour. 0= no pain, 10 = worst imaginable. This outcome is the change in pain between baseline and one hour
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
99 participants
Primary outcome timeframe
one hour
Results posted on
2021-09-22
Participant Flow
Participant milestones
| Measure |
Greater Occipital Nerve Block
Bilateral greater occipital nerve block with bupivacaine 0.5%
\+ Normal saline IV
Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally
|
Metoclopramide
Metoclopramide 10mg IV
\+ Bilateral greater occipital nerve block with normal saline
Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
48
|
|
Overall Study
COMPLETED
|
51
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Greater Occipital Nerve Block
n=51 Participants
Bilateral greater occipital nerve block with bupivacaine 0.5%
\+ Normal saline IV
Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally
|
Metoclopramide
n=48 Participants
Metoclopramide 10mg IV
\+ Bilateral greater occipital nerve block with normal saline
Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 11 • n=51 Participants
|
38 years
STANDARD_DEVIATION 11 • n=48 Participants
|
39 years
STANDARD_DEVIATION 11 • n=99 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=51 Participants
|
34 Participants
n=48 Participants
|
78 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=51 Participants
|
14 Participants
n=48 Participants
|
21 Participants
n=99 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
51 participants
n=51 Participants
|
48 participants
n=48 Participants
|
99 participants
n=99 Participants
|
|
Baseline pain intensity
Severe pain
|
38 Participants
n=51 Participants
|
35 Participants
n=48 Participants
|
73 Participants
n=99 Participants
|
|
Baseline pain intensity
Moderate pain
|
13 Participants
n=51 Participants
|
13 Participants
n=48 Participants
|
26 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: one hourPain score assessed at baseline and one hour. 0= no pain, 10 = worst imaginable. This outcome is the change in pain between baseline and one hour
Outcome measures
| Measure |
Greater Occipital Nerve Block
n=51 Participants
Bilateral greater occipital nerve block with bupivacaine 0.5%
\+ Normal saline IV
Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally
|
Metoclopramide
n=48 Participants
Metoclopramide 10mg IV
\+ Bilateral greater occipital nerve block with normal saline
Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes
|
|---|---|---|
|
0-10 Pain Score
|
5.0 units on a scale
Interval 4.1 to 5.8
|
6.1 units on a scale
Interval 5.2 to 6.9
|
SECONDARY outcome
Timeframe: 48 hoursHeadache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication
Outcome measures
| Measure |
Greater Occipital Nerve Block
n=51 Participants
Bilateral greater occipital nerve block with bupivacaine 0.5%
\+ Normal saline IV
Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally
|
Metoclopramide
n=47 Participants
Metoclopramide 10mg IV
\+ Bilateral greater occipital nerve block with normal saline
Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes
|
|---|---|---|
|
Sustained Headache Relief
|
11 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 48 hoursHeadache = none, achieved in emergency department and maintained for 48 hours
Outcome measures
| Measure |
Greater Occipital Nerve Block
n=51 Participants
Bilateral greater occipital nerve block with bupivacaine 0.5%
\+ Normal saline IV
Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally
|
Metoclopramide
n=48 Participants
Metoclopramide 10mg IV
\+ Bilateral greater occipital nerve block with normal saline
Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes
|
|---|---|---|
|
Sustained Headache Freedom
|
3 Participants
|
7 Participants
|
Adverse Events
Greater Occipital Nerve Block
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Metoclopramide
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Greater Occipital Nerve Block
n=51 participants at risk
Bilateral greater occipital nerve block with bupivacaine 0.5%
\+ Normal saline IV
Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally
|
Metoclopramide
n=48 participants at risk
Metoclopramide 10mg IV
\+ Bilateral greater occipital nerve block with normal saline
Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
7.8%
4/51 • Number of events 4 • 48 hours
|
6.2%
3/48 • Number of events 3 • 48 hours
|
|
Nervous system disorders
drowsiness
|
0.00%
0/51 • 48 hours
|
6.2%
3/48 • Number of events 3 • 48 hours
|
|
Nervous system disorders
headache
|
5.9%
3/51 • Number of events 3 • 48 hours
|
4.2%
2/48 • Number of events 2 • 48 hours
|
|
Injury, poisoning and procedural complications
head numbness
|
7.8%
4/51 • Number of events 4 • 48 hours
|
0.00%
0/48 • 48 hours
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
3.9%
2/51 • Number of events 2 • 48 hours
|
2.1%
1/48 • Number of events 1 • 48 hours
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
3.9%
2/51 • Number of events 2 • 48 hours
|
0.00%
0/48 • 48 hours
|
|
Investigations
Various
|
2.0%
1/51 • 48 hours
|
18.8%
9/48 • 48 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place