Prostate CA
Conditions
Brief summary
Transversus abdominis plane (TAP) blocks are increasingly being performed after abdominal surgery to provide post operative analgesia. Dexamethasone has demonstrated an ability to prolong the effective duration of analgesia in several different peripheral nerve blocks. The study will examine, in a blinded, prospective and randomized fashion, whether the addition of dexamethasone to TAP blocks similarly prolongs blockade and pain relief. The study will compare local anesthetic with and without the addition of dexamethasone in the TAP block.
Detailed description
The study will be done in two phases. In the first phase, patients will be randomized to receive either 20 cc of 0.125% bupivicaine with or without 2 mg of dexamethasone on each side of their abdomen (40 cc and 4 mg in total) and patients who receive the dexamethasone will be compared with patients who did not receive it. In the second phase, we will assess whether patients can serve as their own controls by adding dexamethasone only to one side of the block (one side of the abdomen) and comparing pain relief/efficacy with the contra-lateral plain local anesthetic effect. The study will assess pain relief, opioid consumption, level of blockade, and operator's prospective assessment of likely efficacy, based on the ultrasound visualization of the local anesthetic injection as compared with actual efficacy.
Interventions
DRUGDexamethasone
40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.
PROCEDURETAP block
Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side
Sponsors
Steward St. Elizabeth's Medical Center of Boston, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male patients, between ages 18-85 years old, undergoing Robot-assisted laparoscopic prostatectomy by a single surgeon at a single hospital. * Subjects are physically and mentally able to participate in the study. * Subjects are able to give fully informed consent to participating in this study after demonstrating good understanding of the risks and benefits of the proposed components of the TAP block.
Exclusion criteria
* Demonstrated hypersensitivity or allergy to local anesthetics or dexamethasone. * Any subject whose anatomy, or surgical procedure, in the opinion of the investigator, might preclude the potential successful performance of a TAP block. * Any subject, who in the opinion of the investigator, might be harmed or be a poor candidate for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Request of Additional Analgesia | 24 hours post-op | Documenting the time required by patients to the first request of additional analgesia. |
Secondary
| Measure | Time frame |
|---|---|
| Assess the Efficacy of the TAP Block by Measuring Visual Analog Scales, Total Opioid Use During the First 24 Hours Post-op, and Provider Assessments to Recognize the Overall Efficacy of the Procedure With and Without Dexamethasone Adjunct. | 24 hours post-op |
Countries
United States
Participant flow
Pre-assignment details
No data are available for this study, due to the fact that the PI has left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm 1 Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.
Dexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side. | 0 |
| Treatment Arm 2 Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side
TAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Time to First Request of Additional Analgesia
Documenting the time required by patients to the first request of additional analgesia.
Time frame: 24 hours post-op
Population: No data are available for this study, due to the fact that the PI has left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.
Secondary
Assess the Efficacy of the TAP Block by Measuring Visual Analog Scales, Total Opioid Use During the First 24 Hours Post-op, and Provider Assessments to Recognize the Overall Efficacy of the Procedure With and Without Dexamethasone Adjunct.
Time frame: 24 hours post-op
Population: No data are available for this study, due to the fact that the PI and study staff have left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.