Clinical Trials Directory

Trials / Completed

CompletedNCT01303003

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

Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block: Does it Enhance the Quality and Duration of Analgesia?

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc. · Academic / Other
Sex
Male
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDexamethasone40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.
PROCEDURETAP blockBilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side

Timeline

Start date
2010-12-01
Primary completion
2012-11-01
Completion
2012-11-01
First posted
2011-02-24
Last updated
2018-09-21
Results posted
2018-09-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01303003. Inclusion in this directory is not an endorsement.