Trial Outcomes & Findings for Paravertebral Block vs no Block in Open Pancreaticoduodenectomy (NCT NCT05820997)

NCT ID: NCT05820997

Last Updated: 2025-12-16

Results Overview

The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain. The average score across the 11 questions was calculated for each subject using the minimum and maximum values reported for each subject across the 11 questions.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 2 participants
• Primary outcome timeframe: First 48 hours after surgery
• Results posted on: 2025-12-16

Participant Flow

Participant milestones

Measure	Paravertebral Block Pre Procedure Subject will receive a preoperative paravertebral block only Ropivacaine: Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level	No Paravertebral Block Subject will receive no paravertebral block.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Paravertebral Block vs no Block in Open Pancreaticoduodenectomy

Baseline characteristics by cohort

Measure	Paravertebral Block Pre Procedure n=1 Participants Subject will receive a preoperative paravertebral block only Ropivacaine: Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level	No Paravertebral Block n=1 Participants Subject will receive no paravertebral block.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=6 Participants	0 Participants n=5 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=6 Participants	1 Participants n=5 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=6 Participants	1 Participants n=5 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=6 Participants	1 Participants n=5 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=6 Participants	1 Participants n=5 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: First 48 hours after surgery

The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain. The average score across the 11 questions was calculated for each subject using the minimum and maximum values reported for each subject across the 11 questions.

Outcome measures

Measure	Paravertebral Block Pre Procedure n=1 Participants Subject will receive a preoperative paravertebral block only Ropivacaine: Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level	No Paravertebral Block n=1 Participants Subject will receive no paravertebral block.
Mean Post-operative Pain Score	5 score on a scale Interval 2.0 to 8.0	4 score on a scale Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: Approximately 4-6 days post surgery

Population: Block patient LOS =5. No block patient LOS =6.

Total number of days subjects were admitted to the hospital following surgery

Outcome measures

Measure	Paravertebral Block Pre Procedure n=1 Participants Subject will receive a preoperative paravertebral block only Ropivacaine: Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level	No Paravertebral Block n=1 Participants Subject will receive no paravertebral block.
Hospital Length of Stay	5 days	6 days

SECONDARY outcome

Timeframe: Approximately 2-4 days

Population: No patients had a bowel obstruction.

Number of subjects to experience a bowl obstruction following surgery

Outcome measures

Measure	Paravertebral Block Pre Procedure n=1 Participants Subject will receive a preoperative paravertebral block only Ropivacaine: Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level	No Paravertebral Block n=1 Participants Subject will receive no paravertebral block.
Number of Subjects With a Bowel Obstruction	0 Participants	0 Participants

Adverse Events

Paravertebral Block Pre Procedure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Paravertebral Block

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Paravertebral Block Pre Procedure n=1 participants at risk Subject will receive a preoperative paravertebral block only Ropivacaine: Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level	No Paravertebral Block n=1 participants at risk Subject will receive no paravertebral block.
Gastrointestinal disorders lleus	0.00% 0/1 • Adverse events were collected from the time of surgery until time of discharge, approximately 6 days.	100.0% 1/1 • Adverse events were collected from the time of surgery until time of discharge, approximately 6 days.

Additional Information

Dr. John Stauffer

Mayo Clinic

Phone: 904-953-2000

Email: stauffer.john@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place