Trial Outcomes & Findings for Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis (NCT NCT00658736)

Results Overview

The Pain Disability Index (PDI) measures patients' responses of the extent to which pain limits their abilities to carry out everyday tasks. The index is scored from 0 (no limitation) to 70 (severe limitation). A decrease in score of 10 points or more is regarded as indicating significant improvement in the ability to carry out daily activities.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

1 month after block

Results posted on

2017-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Bupivicaine Alone EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution.	Bupivicaine Plus Triamcinolone EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution mixed with 80 mg Triamcinolone.
Overall Study STARTED	19	21
Overall Study COMPLETED	13	19
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupivicaine and Triamcinolone n=21 Participants EUS guided celiac block with bupivicaine and triamcinolone Triamcinolone	Bupivicaine Alone n=19 Participants EUS guided celiac block with bupivicaine only Bupivicaine alone	Total n=40 Participants Total of all reporting groups
Age, Continuous	39.5 years STANDARD_DEVIATION 10.9 • n=21 Participants	44.1 years STANDARD_DEVIATION 12.5 • n=19 Participants	41.7 years STANDARD_DEVIATION 11.9 • n=40 Participants
Sex: Female, Male Female	9 Participants n=21 Participants	9 Participants n=19 Participants	18 Participants n=40 Participants
Sex: Female, Male Male	12 Participants n=21 Participants	10 Participants n=19 Participants	22 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 1 month after block

The Pain Disability Index (PDI) measures patients' responses of the extent to which pain limits their abilities to carry out everyday tasks. The index is scored from 0 (no limitation) to 70 (severe limitation). A decrease in score of 10 points or more is regarded as indicating significant improvement in the ability to carry out daily activities.

Outcome measures

Outcome measures
Measure	Bupivicaine and Triamcinolone n=21 Participants EUS guided celiac block with bupivicaine and triamcinolone Triamcinolone	Bupivicaine Alone n=19 Participants EUS guided celiac block with bupivicaine only Bupivicaine alone
Change in Pain Disability Index	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 1 month

The SF12 survey measures patients' impressions of their level of health and well-being. The results are reported as two scores: A physical component and a mental component, each of which is reported on a scale of 0 (lowest level of health) to 100 (excellent health). Scores that increase from baseline indicate an improvement in patients' feelings of well-being.

Outcome measures

Outcome measures
Measure	Bupivicaine and Triamcinolone n=21 Participants EUS guided celiac block with bupivicaine and triamcinolone Triamcinolone	Bupivicaine Alone n=19 Participants EUS guided celiac block with bupivicaine only Bupivicaine alone
Change From Baseline in Quality of Life Score at 1 Month - SF12 Physical Component	-0.2 units on a scale Standard Deviation 7.5	1.7 units on a scale Standard Deviation 8.8

Adverse Events

Bupivicaine and Triamcinolone

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Bupivicaine Alone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bupivicaine and Triamcinolone n=21 participants at risk EUS guided celiac block with bupivicaine and triamcinolone Triamcinolone	Bupivicaine Alone n=19 participants at risk EUS guided celiac block with bupivicaine only Bupivicaine alone
Vascular disorders Hypertension urgency	0.00% 0/21	5.3% 1/19 • Number of events 1
Gastrointestinal disorders Abdominal pain	14.3% 3/21 • Number of events 3	5.3% 1/19 • Number of events 1
Gastrointestinal disorders Gastric hematoma	4.8% 1/21 • Number of events 1	0.00% 0/19

Additional Information

Dr. Tyler Stevens

Cleveland Clinic

Phone: 216 445-1996

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place