Pancreaticoduodenectomy
Conditions
Brief summary
The purpose of this study is to compare intra and postoperative pain control between Paravertebral block vs no block in open pancreaticoduodenectomy. Length of stay, and complications will also be recorded. For this study the investigator plans to randomize to obtain objective data for clinical decisions and improve patient outcomes. Following surgery patients in both groups, data will be collected from the first 48 hours after surgery and at discharge.
Interventions
DRUGRopivacaine
Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients willing and have signed consent. * Nonpregnant adults undergoing open pancreaticoduodenectomy via standard upper midline incision without contraindications to para vertebral block (PVB)
Exclusion criteria
* Not able or unwilling to sign consent. * Currently pregnant or lactating. * Patients with chronic pain, requiring daily opiate use at time of surgery. * Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Post-operative Pain Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | Approximately 4-6 days post surgery | Total number of days subjects were admitted to the hospital following surgery |
| Number of Subjects With a Bowel Obstruction | Approximately 2-4 days | Number of subjects to experience a bowl obstruction following surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1 |
| No Paravertebral Block Subject will receive no paravertebral block. | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Paravertebral Block Pre Procedure | No Paravertebral Block | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Mean Post-operative Pain Score
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.
Time frame: First 48 hours after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Paravertebral Block Pre Procedure | Mean Post-operative Pain Score | 5 score on a scale |
| No Paravertebral Block | Mean Post-operative Pain Score | 4 score on a scale |
Secondary
Hospital Length of Stay
Total number of days subjects were admitted to the hospital following surgery
Time frame: Approximately 4-6 days post surgery
Population: Block patient LOS =5. No block patient LOS =6.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paravertebral Block Pre Procedure | Hospital Length of Stay | 5 days |
| No Paravertebral Block | Hospital Length of Stay | 6 days |
Secondary
Number of Subjects With a Bowel Obstruction
Number of subjects to experience a bowl obstruction following surgery
Time frame: Approximately 2-4 days
Population: No patients had a bowel obstruction.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Paravertebral Block Pre Procedure | Number of Subjects With a Bowel Obstruction | 0 Participants |
| No Paravertebral Block | Number of Subjects With a Bowel Obstruction | 0 Participants |