Trial Outcomes & Findings for A Research Study to Examine the Difference Between Local Anesthetics Alone and Local Anesthetics Plus Steroids in the Treatment of Chronic Headache (NCT NCT00203294)

Results Overview

Headache severity was assessed on an 11-point verbal scale twenty minutes after treatment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

20 minutes

Results posted on

2014-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	GON Block Only Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.	GON Block Plus Steroid Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
Overall Study STARTED	22	23
Overall Study COMPLETED	14	10
Overall Study NOT COMPLETED	8	13

Reasons for withdrawal

Reasons for withdrawal
Measure	GON Block Only Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.	GON Block Plus Steroid Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
Overall Study Withdrawal by Subject	8	13

Baseline Characteristics

A Research Study to Examine the Difference Between Local Anesthetics Alone and Local Anesthetics Plus Steroids in the Treatment of Chronic Headache

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GON Block Only n=22 Participants Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.	GON Block Plus Steroid n=23 Participants Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=39 Participants	23 Participants n=41 Participants	45 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Sex: Female, Male Female	17 Participants n=39 Participants	20 Participants n=41 Participants	37 Participants n=35 Participants
Sex: Female, Male Male	5 Participants n=39 Participants	3 Participants n=41 Participants	8 Participants n=35 Participants
Region of Enrollment United States	22 participants n=39 Participants	23 participants n=41 Participants	45 participants n=35 Participants

PRIMARY outcome

Timeframe: 20 minutes

Population: There were 15 patients in group A (no steroids injected) and 14 in group B (steroids injected).

Headache severity was assessed on an 11-point verbal scale twenty minutes after treatment

Outcome measures

Outcome measures
Measure	Lidocaine 2% and Bupivacaine 0.25% Plus Saline n=15 Participants Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections	Lidocaine 2% and Bupivacaine 0.25% Plus Triamcinolone 40 mg. n=14 Participants Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections
Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain	-3.29 units on a scale Standard Deviation 2.76	-3.70 units on a scale Standard Deviation 1.49

PRIMARY outcome

Timeframe: 20 minutes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 20 minutes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 20 minutes

Outcome measures

Outcome data not reported

Adverse Events

GON Block Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GON Block Plus Steroid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathleen Bradley

Thomas Jefferson University

Phone: 215-955-2025

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place