An interventional study of Dexamethasone and TAP block in Prostate CA, sponsored by Steward St. Elizabeth's Medical Center of Boston, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-09-21.
Sponsored by Steward St. Elizabeth's Medical Center of Boston, Inc. · Not applicable, Interventional, and Treatment
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.
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.
Steward St. Elizabeth's Medical Center of Boston, Inc. is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.
Drug: Dexamethasone
Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side
Procedure: TAP block
40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.
Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side
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
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
| Milestone | Treatment Arm 1 | Treatment Arm 2 |
|---|---|---|
| Started | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 0 | 0 |
Documenting the time required by patients to the first request of additional analgesia.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm 1 | — | — | — |
| Treatment Arm 2 | — | — | — |
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.
| Age, Categorical | Treatment Arm 1 | Treatment Arm 2 | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Age, Continuous | Treatment Arm 1 | Treatment Arm 2 | Total |
|---|
| Sex: Female, Male | Treatment Arm 1 | Treatment Arm 2 | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Region of Enrollment(participants) | Treatment Arm 1 | Treatment Arm 2 | Total |
|---|
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Steward St. Elizabeth's Medical Center of Boston, Inc.