Trial Outcomes & Findings for Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block (NCT NCT01303003)

NCT ID: NCT01303003

Last Updated: 2018-09-21

Results Overview

Documenting the time required by patients to the first request of additional analgesia.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

24 hours post-op

Results posted on

2018-09-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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.
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
Overall Study
STARTED
0
0
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 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.

Documenting the time required by patients to the first request of additional analgesia.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Treatment Arm 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment Arm 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Meghan Cashman, IRB Manager

Steward St. Elizabeth's Medical Center

Phone: 617-789-2804

Results disclosure agreements

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